Comparison of Four Combination Chemotherapy Regimens Using Cisplatin in Treating Patients With Stage IVB, Recurrent, or Persistent Cancer of the Cervix

• Sponsor: Gynecologic Oncology Group (Other)
• Overall Status: Completed
• CT.gov ID: NCT00064077
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 513
• Location: 1
• Arms: 4
• Duration (Months): 177
• Patients Per Site Per Month: 2.9

Study Details

Study Description

Brief Summary

This randomized phase III trial is studying four combination chemotherapy regimens using cisplatin to compare how well they work in treating women with stage IVB, recurrent, or persistent cancer of the cervix. Drugs used in chemotherapy such as cisplatin, paclitaxel, vinorelbine, gemcitabine, and topotecan, use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which combination chemotherapy regimen containing cisplatin is most effective in treating cervical cancer.

Condition or Disease	Intervention/Treatment	Phase
Cervical Adenocarcinoma; Cervical Adenosquamous Carcinoma; Cervical Squamous Cell Carcinoma; Recurrent Cervical Carcinoma; Stage IVB Cervical Cancer	Drug: Cisplatin; Drug: Gemcitabine Hydrochloride; Drug: Paclitaxel; Other: Quality-of-Life Assessment; Drug: Topotecan Hydrochloride; Drug: Vinorelbine Tartrate	Phase 3

Detailed Description

PRIMARY OBJECTIVES:

1. Compare the survival and response of patients with stage IVB, recurrent, or persistent carcinoma of the cervix when treated with paclitaxel and cisplatin vs vinorelbine and cisplatin vs gemcitabine and cisplatin vs topotecan and cisplatin.

2. Compare the toxic effects of these regimens in these patients. III. Compare the quality of life of patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 4 treatment arms.

ARM I: Patients receive paclitaxel IV over 24 hours on day 1 and cisplatin IV over 1-4 hours on day 2.

ARM II: Patients receive vinorelbine IV over 6-10 minutes on days 1 and 8 and cisplatin IV over 1-4 hours on day 1.

ARM III: Patients receive gemcitabine IV over 30-60 minutes on days 1 and 8 and cisplatin as in arm II.

ARM IV: Patients receive topotecan IV over 30 minutes on days 1-3 and cisplatin as in arm II.

In all arms, treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, before courses 2 and 5, and at 9 months after study entry.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

Study Design

• Study Type: Interventional
• Actual Enrollment: 513 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Randomized Phase III Trial Of Paclitaxel Plus Cisplatin Versus Vinorelbine Plus Cisplatin Versus Gemcitabine Plus Cisplatin Versus Topotecan Plus Cisplatin In Stage IVB, Recurrent Or Persistent Carcinoma of the Cervix
• Study Start Date: May 1, 2003
• Actual Primary Completion Date: Jan 1, 2011
• Actual Study Completion Date: Jan 30, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm I (paclitaxel, cisplatin) Patients receive paclitaxel IV over 24 hours on day 1 and cisplatin IV over 1-4 hours on day 2.	Drug: Cisplatin; Given IV; Other Names: Abiplatin Blastolem Briplatin CDDP Cis-diammine-dichloroplatinum Cis-diamminedichloridoplatinum Cis-diamminedichloro Platinum (II) Cis-diamminedichloroplatinum Cis-dichloroammine Platinum (II) Cis-platinous Diamine Dichloride Cis-platinum Cis-platinum II Cis-platinum II Diamine Dichloride Cismaplat Cisplatina Cisplatinum Cisplatyl Citoplatino Citosin Cysplatyna DDP Lederplatin Metaplatin Neoplatin Peyrone's Chloride Peyrone's Salt Placis Plastistil Platamine Platiblastin Platiblastin-S Platinex Platinol Platinol- AQ Platinol-AQ Platinol-AQ VHA Plus Platinoxan Platinum Platinum Diamminodichloride Platiran Platistin Platosin ; Drug: Paclitaxel; Given IV; Other Names: Anzatax Asotax Bristaxol Praxel Taxol Taxol Konzentrat ; Other: Quality-of-Life Assessment; Ancillary studies; Other Names: Quality of Life Assessment
Experimental: Arm II (vinorelbine, cisplatin) Patients receive vinorelbine IV over 6-10 minutes on days 1 and 8 and cisplatin IV over 1-4 hours on day 1.	Drug: Cisplatin; Given IV; Other Names: Abiplatin Blastolem Briplatin CDDP Cis-diammine-dichloroplatinum Cis-diamminedichloridoplatinum Cis-diamminedichloro Platinum (II) Cis-diamminedichloroplatinum Cis-dichloroammine Platinum (II) Cis-platinous Diamine Dichloride Cis-platinum Cis-platinum II Cis-platinum II Diamine Dichloride Cismaplat Cisplatina Cisplatinum Cisplatyl Citoplatino Citosin Cysplatyna DDP Lederplatin Metaplatin Neoplatin Peyrone's Chloride Peyrone's Salt Placis Plastistil Platamine Platiblastin Platiblastin-S Platinex Platinol Platinol- AQ Platinol-AQ Platinol-AQ VHA Plus Platinoxan Platinum Platinum Diamminodichloride Platiran Platistin Platosin ; Other: Quality-of-Life Assessment; Ancillary studies; Other Names: Quality of Life Assessment ; Drug: Vinorelbine Tartrate; Given IV; Other Names: Biovelbin Eunades KW-2307 Navelbine Navelbine Ditartrate NVB Vinorelbine Ditartrate
Experimental: Arm III (gemcitabine, cisplatin) Patients receive gemcitabine IV over 30-60 minutes on days 1 and 8 and cisplatin as in arm II.	Drug: Cisplatin; Given IV; Other Names: Abiplatin Blastolem Briplatin CDDP Cis-diammine-dichloroplatinum Cis-diamminedichloridoplatinum Cis-diamminedichloro Platinum (II) Cis-diamminedichloroplatinum Cis-dichloroammine Platinum (II) Cis-platinous Diamine Dichloride Cis-platinum Cis-platinum II Cis-platinum II Diamine Dichloride Cismaplat Cisplatina Cisplatinum Cisplatyl Citoplatino Citosin Cysplatyna DDP Lederplatin Metaplatin Neoplatin Peyrone's Chloride Peyrone's Salt Placis Plastistil Platamine Platiblastin Platiblastin-S Platinex Platinol Platinol- AQ Platinol-AQ Platinol-AQ VHA Plus Platinoxan Platinum Platinum Diamminodichloride Platiran Platistin Platosin ; Drug: Gemcitabine Hydrochloride; Other Names: dFdCyd Difluorodeoxycytidine Hydrochloride Gemzar LY-188011 ; Other: Quality-of-Life Assessment; Ancillary studies; Other Names: Quality of Life Assessment
Experimental: Arm IV (topotecan, cisplatin) Patients receive topotecan IV over 30 minutes on days 1-3 and cisplatin as in arm II.	Drug: Cisplatin; Given IV; Other Names: Abiplatin Blastolem Briplatin CDDP Cis-diammine-dichloroplatinum Cis-diamminedichloridoplatinum Cis-diamminedichloro Platinum (II) Cis-diamminedichloroplatinum Cis-dichloroammine Platinum (II) Cis-platinous Diamine Dichloride Cis-platinum Cis-platinum II Cis-platinum II Diamine Dichloride Cismaplat Cisplatina Cisplatinum Cisplatyl Citoplatino Citosin Cysplatyna DDP Lederplatin Metaplatin Neoplatin Peyrone's Chloride Peyrone's Salt Placis Plastistil Platamine Platiblastin Platiblastin-S Platinex Platinol Platinol- AQ Platinol-AQ Platinol-AQ VHA Plus Platinoxan Platinum Platinum Diamminodichloride Platiran Platistin Platosin ; Other: Quality-of-Life Assessment; Ancillary studies; Other Names: Quality of Life Assessment ; Drug: Topotecan Hydrochloride; Given IV; Other Names: Hycamptamine Hycamtin SKF S-104864-A Topotecan HCl topotecan hydrochloride (oral)

Outcome Measures

Primary Outcome Measures

1. Duration of Overall Survival (OS) [Baseline, every other cycle during treatment, then every 3 months for 2 years, the every 6 months for 3 years (up to 5 years)]

   Overall survival is defined as the duration of time from study entry to time of death or the date of last contact.

Secondary Outcome Measures

1. Frequency of Response Using RECIST Version 1.0 [Baseline, every other cycle during treatment, then every 3 months for 2 years, the every 6 months for 3 years (up to 5 years)]

   RECIST 1.0 defines complete response as the disappearance of all target lesions and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Partial response is defined as at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of non-target lesions and no new lesions. Documentation by two disease assessments at least 4 weeks apart is required. In the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam, which is not radiographically measurable, a 50% decrease in the LD is required. These patients will have their response classified according to the definitions stated above.

2. Duration of Progression-free Survival (PFS) [Baseline, every other cycle during treatment, then every 3 months for 2 years, the every 6 months for 3 years (up to 5 years)]

   Progression-free survival (PFS) was defined as the period from study entry until disease progression, death, or the last date of contact. Progression is defined according to RECIST v1.0 as at least a 20% increase in the sum of LD target lesions taking as reference the smallest sum LD recorded since study entry, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression, or unequivocal progression of existing non-target lesions.

3. Patient-reported Quality of Life as Measured by the Functional Assessment of Cancer Therapy (FACT)-Cervical Trial Outcome of Index (FACT-Cx TOI) [Baseline (pre-cycle 1), Pre-cycle 2, Pre-cycle 5, 9 months post cycle 1]

   The FACT-Cx TOI is a scale for assessing general QOL of cervical cancer patients.consisting of three subscales: Physical Well Being (7 items), Functional Well Being (7 items), and Cervical Cancer subscale (15 items). Each item in the FACT-Cx TOI was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). For the negative statements (or questions), reversal was performed prior to score calculation. According to the FACIT measurement system, a subscale score was the summation of the individual item scores if more than 50% of subscale items were answered. When unanswered items existed, a subscale score was prorated by multiplying the mean of the answered item scores by the number of items in the subscale. The score is calculated as the sum of the subscale scores if more than 80% of the FACT-Cx TOI items provide valid answers and all of the component subscales have valid scores. The score ranges 0-116 with a large score suggesting better QOL.

4. Pain, Assessed by Brief Pain Inventory [Baseline (pre-cycle 1), Pre-cycle 2, Pre-cycle 5, 9 months post cycle 1]

   Single item from the Brief Pain Inventory (BPI) assessing "worst pain" in the past 24 hours, on a 0-10 scale with a higher score indicating more pain than a low score.

5. Patient Reported Neurotoxicity Symptoms as Measured With the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity Subscale (Short Version) (FACT/GOG-Ntx Subscale). [Baseline (pre-cycle 1), Pre-cycle 2, Pre-cycle 5, 9 months post cycle 1]

   The FACT/GOG-Ntx subscale contains 4 items. Each item was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). For the negative items, reversal was performed prior to score calculation. According to the FACIT measurement system, the Ntx score was the summation of the individual item scores if more than 50% of subscale items were answered. When unanswered items existed, a subscale score was prorated by multiplying the mean of the answered item scores by the number of items in the scale. The Ntx score ranges 0-16 with a large score suggests less neurotoxicity.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Histologically confirmed squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix

• Stage IVB, recurrent, or persistent disease

• Not amenable to curative surgery and/or radiotherapy

• At least 1 unidimensionally measurable lesion

• At least 20 mm by palpation, plain x-ray, CT scan, or MRI OR at least 10 mm by spiral CT scan

• Biopsy confirmation required if lesion is less than 30 mm

• Target lesion must be outside of a previously irradiated field

• No craniospinal metastases

• Performance status - GOG 0-1

• Absolute neutrophil count at least 1,500/mm^3

• Platelet count at least 100,000/mm^3

• Bilirubin no greater than 1.5 times normal

• Alkaline phosphatase no greater than 3 times normal

• AST no greater than 3 times normal

• Creatinine ≤ 1.2 mg/dL

• Creatinine > 1.2 mg/dL but < 1.5 mg/dL AND creatinine clearance ≥ 50 mL/min

• No bilateral hydronephrosis not alleviated by ureteral stents or percutaneous drainage

• Not pregnant or nursing

• Fertile patients must use effective contraception

• No prior or concurrent malignancy within the past 5 years except nonmelanoma skin cancer

• No prior malignancy whose treatment contraindicates the current study therapy

• No concurrent clinically significant infection

• No concurrent cytokines

• At least 6 weeks since prior chemoradiotherapy and recovered

• No prior chemotherapy (except when concurrently administered with radiotherapy)

• At least 3 weeks since prior radiotherapy and recovered

• Recovered from prior surgery

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Gynecologic Oncology Group	Philadelphia	Pennsylvania	United States	19103

Sponsors and Collaborators

• Gynecologic Oncology Group
• National Cancer Institute (NCI)

Investigators

• Principal Investigator: Bradley Monk, Gynecologic Oncology Group

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Gynecologic Oncology Group
• ClinicalTrials.gov Identifier: NCT00064077
• Other Study ID Numbers: GOG-0204; NCI-2012-02540; CDR0000306463; GOG-0204; GOG-0204; U10CA027469
• First Posted: Jul 9, 2003
• Last Update Posted: Oct 17, 2018
• Last Verified: Aug 1, 2018

• Additional relevant MeSH terms: Carcinoma; Carcinoma, Adenosquamous; Recurrence; Gemcitabine; Paclitaxel; Vinorelbine; Cisplatin; Albumin-Bound Paclitaxel; Topotecan

Study Results

Participant Flow

Recruitment Details	From May 2003 through April 2007, 513 patients were enrolled. Interim analysis recommended early closure for futility in January 2004.
Pre-assignment Detail	Until January 2004, the study consisted of only two arms. Interim analysis recommended early closure for futility. 41 patients were enrolled until that point. These 41 patients were excluded from analysis. Two more arms were added and the study re-opened with 4 arms. The 472 patients enrolled after 1/26/2004 were included in analysis.

Arm/Group Title	Arm I (Paclitaxel, Cisplatin)	Arm II (Vinorelbine, Cisplatin)	Arm III (Gemcitabine, Cisplatin)	Arm IV (Topotecan, Cisplatin)
Arm/Group Description	Patients receive paclitaxel IV over 24 hours on day 1 and cisplatin IV over 1-4 hours on day 2. Cisplatin: Given IV Paclitaxel: Given IV Quality-of-Life Assessment: Ancillary studies	Patients receive vinorelbine IV over 6-10 minutes on days 1 and 8 and cisplatin IV over 1-4 hours on day 1. Cisplatin: Given IV Quality-of-Life Assessment: Ancillary studies Vinorelbine Tartrate: Given IV	Patients receive gemcitabine IV over 30-60 minutes on days 1 and 8 and cisplatin as in arm II. Cisplatin: Given IV Gemcitabine Hydrochloride Quality-of-Life Assessment: Ancillary studies	Patients receive topotecan IV over 30 minutes on days 1-3 and cisplatin as in arm II. Cisplatin: Given IV Quality-of-Life Assessment: Ancillary studies Topotecan Hydrochloride: Given IV
Period Title: Overall Study
STARTED	118	117	119	118
COMPLETED	103	108	112	111
NOT COMPLETED	15	9	7	7

Baseline Characteristics

Arm/Group Title	Arm I (Paclitaxel, Cisplatin)	Arm II (Vinorelbine, Cisplatin)	Arm III (Gemcitabine, Cisplatin)	Arm IV (Topotecan, Cisplatin)	Total
Arm/Group Description	Patients receive paclitaxel IV over 24 hours on day 1 and cisplatin IV over 1-4 hours on day 2. Cisplatin: Given IV Paclitaxel: Given IV Quality-of-Life Assessment: Ancillary studies	Patients receive vinorelbine IV over 6-10 minutes on days 1 and 8 and cisplatin IV over 1-4 hours on day 1. Cisplatin: Given IV Quality-of-Life Assessment: Ancillary studies Vinorelbine Tartrate: Given IV	Patients receive gemcitabine IV over 30-60 minutes on days 1 and 8 and cisplatin as in arm II. Cisplatin: Given IV Gemcitabine Hydrochloride Quality-of-Life Assessment: Ancillary studies	Patients receive topotecan IV over 30 minutes on days 1-3 and cisplatin as in arm II. Cisplatin: Given IV Quality-of-Life Assessment: Ancillary studies Topotecan Hydrochloride: Given IV	Total of all reporting groups
Overall Participants	103	108	112	111	434
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	50	49	45	48	48
Sex: Female, Male (Count of Participants)
Female	103 100%	108 100%	112 100%	111 100%	434 100%
Male	0 0%	0 0%	0 0%	0 0%	0 0%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	16 15.5%	10 9.3%	20 17.9%	19 17.1%	65 15%
Not Hispanic or Latino	75 72.8%	90 83.3%	86 76.8%	78 70.3%	329 75.8%
Unknown or Not Reported	12 11.7%	8 7.4%	6 5.4%	14 12.6%	40 9.2%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	2 1.9%	1 0.9%	1 0.9%	1 0.9%	5 1.2%
Asian	4 3.9%	6 5.6%	3 2.7%	4 3.6%	17 3.9%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%	0 0%
Black or African American	19 18.4%	20 18.5%	23 20.5%	17 15.3%	79 18.2%
White	75 72.8%	79 73.1%	80 71.4%	82 73.9%	316 72.8%
More than one race	0 0%	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	3 2.9%	2 1.9%	5 4.5%	7 6.3%	17 3.9%

Outcome Measures

1. Primary Outcome

Title	Duration of Overall Survival (OS)
Description	Overall survival is defined as the duration of time from study entry to time of death or the date of last contact.
Time Frame	Baseline, every other cycle during treatment, then every 3 months for 2 years, the every 6 months for 3 years (up to 5 years)

Outcome Measure Data

Analysis Population Description

Evaluable (treatment)

Arm/Group Title	Arm I (Paclitaxel, Cisplatin)	Arm II (Vinorelbine, Cisplatin)	Arm III (Gemcitabine, Cisplatin)	Arm IV (Topotecan, Cisplatin)
Arm/Group Description	Patients receive paclitaxel IV over 24 hours on day 1 and cisplatin IV over 1-4 hours on day 2. Cisplatin: Given IV Paclitaxel: Given IV Quality-of-Life Assessment: Ancillary studies	Patients receive vinorelbine IV over 6-10 minutes on days 1 and 8 and cisplatin IV over 1-4 hours on day 1. Cisplatin: Given IV Quality-of-Life Assessment: Ancillary studies Vinorelbine Tartrate: Given IV	Patients receive gemcitabine IV over 30-60 minutes on days 1 and 8 and cisplatin as in arm II. Cisplatin: Given IV Gemcitabine Hydrochloride Quality-of-Life Assessment: Ancillary studies	Patients receive topotecan IV over 30 minutes on days 1-3 and cisplatin as in arm II. Cisplatin: Given IV Quality-of-Life Assessment: Ancillary studies Topotecan Hydrochloride: Given IV
Measure Participants	103	108	112	111
Median (95% Confidence Interval) [months]	12.87	9.99	10.28	10.25

2. Secondary Outcome

Title	Frequency of Response Using RECIST Version 1.0
Description	RECIST 1.0 defines complete response as the disappearance of all target lesions and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Partial response is defined as at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of non-target lesions and no new lesions. Documentation by two disease assessments at least 4 weeks apart is required. In the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam, which is not radiographically measurable, a 50% decrease in the LD is required. These patients will have their response classified according to the definitions stated above.
Time Frame	Baseline, every other cycle during treatment, then every 3 months for 2 years, the every 6 months for 3 years (up to 5 years)

Outcome Measure Data

Analysis Population Description

Evaluable (treatment)

Arm/Group Title	Arm I (Paclitaxel, Cisplatin)	Arm II (Vinorelbine, Cisplatin)	Arm III (Gemcitabine, Cisplatin)	Arm IV (Topotecan, Cisplatin)
Arm/Group Description	Patients receive paclitaxel IV over 24 hours on day 1 and cisplatin IV over 1-4 hours on day 2. Cisplatin: Given IV Paclitaxel: Given IV Quality-of-Life Assessment: Ancillary studies	Patients receive vinorelbine IV over 6-10 minutes on days 1 and 8 and cisplatin IV over 1-4 hours on day 1. Cisplatin: Given IV Quality-of-Life Assessment: Ancillary studies Vinorelbine Tartrate: Given IV	Patients receive gemcitabine IV over 30-60 minutes on days 1 and 8 and cisplatin as in arm II. Cisplatin: Given IV Gemcitabine Hydrochloride Quality-of-Life Assessment: Ancillary studies	Patients receive topotecan IV over 30 minutes on days 1-3 and cisplatin as in arm II. Cisplatin: Given IV Quality-of-Life Assessment: Ancillary studies Topotecan Hydrochloride: Given IV
Measure Participants	103	108	112	111
Complete Response	3 2.9%	8 7.4%	1 0.9%	2 1.8%
Partial Response	27 26.2%	20 18.5%	24 21.4%	24 21.6%
Stable Disease	50 48.5%	46 42.6%	54 48.2%	53 47.7%
Progressive Disease/other	23 22.3%	34 31.5%	33 29.5%	32 28.8%

3. Secondary Outcome

Title	Duration of Progression-free Survival (PFS)
Description	Progression-free survival (PFS) was defined as the period from study entry until disease progression, death, or the last date of contact. Progression is defined according to RECIST v1.0 as at least a 20% increase in the sum of LD target lesions taking as reference the smallest sum LD recorded since study entry, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression, or unequivocal progression of existing non-target lesions.
Time Frame	Baseline, every other cycle during treatment, then every 3 months for 2 years, the every 6 months for 3 years (up to 5 years)

Outcome Measure Data

Analysis Population Description

Evaluable (treatment)

Arm/Group Title	Arm I (Paclitaxel, Cisplatin)	Arm II (Vinorelbine, Cisplatin)	Arm III (Gemcitabine, Cisplatin)	Arm IV (Topotecan, Cisplatin)
Arm/Group Description	Patients receive paclitaxel IV over 24 hours on day 1 and cisplatin IV over 1-4 hours on day 2. Cisplatin: Given IV Paclitaxel: Given IV Quality-of-Life Assessment: Ancillary studies	Patients receive vinorelbine IV over 6-10 minutes on days 1 and 8 and cisplatin IV over 1-4 hours on day 1. Cisplatin: Given IV Quality-of-Life Assessment: Ancillary studies Vinorelbine Tartrate: Given IV	Patients receive gemcitabine IV over 30-60 minutes on days 1 and 8 and cisplatin as in arm II. Cisplatin: Given IV Gemcitabine Hydrochloride Quality-of-Life Assessment: Ancillary studies	Patients receive topotecan IV over 30 minutes on days 1-3 and cisplatin as in arm II. Cisplatin: Given IV Quality-of-Life Assessment: Ancillary studies Topotecan Hydrochloride: Given IV
Measure Participants	103	108	112	111
Median (95% Confidence Interval) [months]	5.82	3.98	4.70	4.57

4. Secondary Outcome

Title	Patient-reported Quality of Life as Measured by the Functional Assessment of Cancer Therapy (FACT)-Cervical Trial Outcome of Index (FACT-Cx TOI)
Description	The FACT-Cx TOI is a scale for assessing general QOL of cervical cancer patients.consisting of three subscales: Physical Well Being (7 items), Functional Well Being (7 items), and Cervical Cancer subscale (15 items). Each item in the FACT-Cx TOI was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). For the negative statements (or questions), reversal was performed prior to score calculation. According to the FACIT measurement system, a subscale score was the summation of the individual item scores if more than 50% of subscale items were answered. When unanswered items existed, a subscale score was prorated by multiplying the mean of the answered item scores by the number of items in the subscale. The score is calculated as the sum of the subscale scores if more than 80% of the FACT-Cx TOI items provide valid answers and all of the component subscales have valid scores. The score ranges 0-116 with a large score suggesting better QOL.
Time Frame	Baseline (pre-cycle 1), Pre-cycle 2, Pre-cycle 5, 9 months post cycle 1

Outcome Measure Data

Analysis Population Description

Patients who provided baseline and ≥ one follow-up assessments

Arm/Group Title	Arm I (Paclitaxel, Cisplatin)	Arm II (Vinorelbine, Cisplatin)	Arm III (Gemcitabine, Cisplatin)	Arm IV (Topotecan, Cisplatin)
Arm/Group Description	Patients receive paclitaxel IV over 24 hours on day 1 and cisplatin IV over 1-4 hours on day 2. Cisplatin: Given IV Paclitaxel: Given IV Quality-of-Life Assessment: Ancillary studies	Patients receive vinorelbine IV over 6-10 minutes on days 1 and 8 and cisplatin IV over 1-4 hours on day 1. Cisplatin: Given IV Quality-of-Life Assessment: Ancillary studies Vinorelbine Tartrate: Given IV	Patients receive gemcitabine IV over 30-60 minutes on days 1 and 8 and cisplatin as in arm II. Cisplatin: Given IV Gemcitabine Hydrochloride Quality-of-Life Assessment: Ancillary studies	Patients receive topotecan IV over 30 minutes on days 1-3 and cisplatin as in arm II. Cisplatin: Given IV Quality-of-Life Assessment: Ancillary studies Topotecan Hydrochloride: Given IV
Measure Participants	86	89	92	96
Baseline	66.6 (17.6)	69.1 (18.6)	67.9 (19.5)	68.1 (19.2)
Pre-cycle 2	65.2 (17.6)	65.5 (15.8)	65.3 (18.2)	66.2 (16.3)
Pre-cycle 5	70.5 (16.5)	66.6 (17.4)	64.5 (16.5)	68.4 (15.5)
9 months post cycle 1	71.9 (16.6)	69.9 (18.8)	68.6 (19.5)	70.9 (17.9)

5. Secondary Outcome

Title	Pain, Assessed by Brief Pain Inventory
Description	Single item from the Brief Pain Inventory (BPI) assessing "worst pain" in the past 24 hours, on a 0-10 scale with a higher score indicating more pain than a low score.
Time Frame	Baseline (pre-cycle 1), Pre-cycle 2, Pre-cycle 5, 9 months post cycle 1

Outcome Measure Data

Analysis Population Description

Patients who provided baseline and ≥ one follow-up assessments

Arm/Group Title	Arm I (Paclitaxel, Cisplatin)	Arm II (Vinorelbine, Cisplatin)	Arm III (Gemcitabine, Cisplatin)	Arm IV (Topotecan, Cisplatin)
Arm/Group Description	Patients receive paclitaxel IV over 24 hours on day 1 and cisplatin IV over 1-4 hours on day 2. Cisplatin: Given IV Paclitaxel: Given IV Quality-of-Life Assessment: Ancillary studies	Patients receive vinorelbine IV over 6-10 minutes on days 1 and 8 and cisplatin IV over 1-4 hours on day 1. Cisplatin: Given IV Quality-of-Life Assessment: Ancillary studies Vinorelbine Tartrate: Given IV	Patients receive gemcitabine IV over 30-60 minutes on days 1 and 8 and cisplatin as in arm II. Cisplatin: Given IV Gemcitabine Hydrochloride Quality-of-Life Assessment: Ancillary studies	Patients receive topotecan IV over 30 minutes on days 1-3 and cisplatin as in arm II. Cisplatin: Given IV Quality-of-Life Assessment: Ancillary studies Topotecan Hydrochloride: Given IV
Measure Participants	74	83	86	92
Baseline	4.0 (2.8)	3.9 (3.2)	3.3 (3.0)	3.6 (3.3)
Pre-cycle 2	3.5 (2.9)	3.5 (2.8)	3.4 (3.0)	3.6 (3.1)
Pre-cycle 5	3.6 (3.1)	4.0 (2.7)	3.5 (3.0)	2.5 (3.0)
9 months post cycle 1	2.3 (3.0)	3.2 (2.9)	3.7 (3.0)	2.9 (2.7)

6. Secondary Outcome

Title	Patient Reported Neurotoxicity Symptoms as Measured With the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity Subscale (Short Version) (FACT/GOG-Ntx Subscale).
Description	The FACT/GOG-Ntx subscale contains 4 items. Each item was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). For the negative items, reversal was performed prior to score calculation. According to the FACIT measurement system, the Ntx score was the summation of the individual item scores if more than 50% of subscale items were answered. When unanswered items existed, a subscale score was prorated by multiplying the mean of the answered item scores by the number of items in the scale. The Ntx score ranges 0-16 with a large score suggests less neurotoxicity.
Time Frame	Baseline (pre-cycle 1), Pre-cycle 2, Pre-cycle 5, 9 months post cycle 1

Outcome Measure Data

Analysis Population Description

Patients who provided baseline and ≥ one follow-up assessments

Arm/Group Title	Arm I (Paclitaxel, Cisplatin)	Arm II (Vinorelbine, Cisplatin)	Arm III (Gemcitabine, Cisplatin)	Arm IV (Topotecan, Cisplatin)
Arm/Group Description	Patients receive paclitaxel IV over 24 hours on day 1 and cisplatin IV over 1-4 hours on day 2. Cisplatin: Given IV Paclitaxel: Given IV Quality-of-Life Assessment: Ancillary studies	Patients receive vinorelbine IV over 6-10 minutes on days 1 and 8 and cisplatin IV over 1-4 hours on day 1. Cisplatin: Given IV Quality-of-Life Assessment: Ancillary studies Vinorelbine Tartrate: Given IV	Patients receive gemcitabine IV over 30-60 minutes on days 1 and 8 and cisplatin as in arm II. Cisplatin: Given IV Gemcitabine Hydrochloride Quality-of-Life Assessment: Ancillary studies	Patients receive topotecan IV over 30 minutes on days 1-3 and cisplatin as in arm II. Cisplatin: Given IV Quality-of-Life Assessment: Ancillary studies Topotecan Hydrochloride: Given IV
Measure Participants	84	89	91	96
Baseline	14.4 (2.9)	13.5 (3.4)	14.2 (2.9)	14.1 (3.5)
Pre-cycle 2	14.1 (3.2)	13.3 (3.6)	13.7 (3.5)	14.2 (3.2)
Pre-cycle 5	13.1 (3.5)	13.1 (3.7)	14.1 (3.0)	14.4 (3.2)
9 months post cycle 1	11.1 (5.2)	11.4 (4.7)	12.3 (3.7)	13.1 (3.5)

Adverse Events

Time Frame	Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.
Arm/Group Title	Arm I (Paclitaxel, Cisplatin)		Arm II (Vinorelbine, Cisplatin)		Arm III (Gemcitabine, Cisplatin)		Arm IV (Topotecan, Cisplatin)
Arm/Group Description	Patients receive paclitaxel IV over 24 hours on day 1 and cisplatin IV over 1-4 hours on day 2. Cisplatin: Given IV Paclitaxel: Given IV Quality-of-Life Assessment: Ancillary studies		Patients receive vinorelbine IV over 6-10 minutes on days 1 and 8 and cisplatin IV over 1-4 hours on day 1. Cisplatin: Given IV Quality-of-Life Assessment: Ancillary studies Vinorelbine Tartrate: Given IV		Patients receive gemcitabine IV over 30-60 minutes on days 1 and 8 and cisplatin as in arm II. Cisplatin: Given IV Gemcitabine Hydrochloride Quality-of-Life Assessment: Ancillary studies		Patients receive topotecan IV over 30 minutes on days 1-3 and cisplatin as in arm II. Cisplatin: Given IV Quality-of-Life Assessment: Ancillary studies Topotecan Hydrochloride: Given IV
All Cause Mortality
	Arm I (Paclitaxel, Cisplatin)		Arm II (Vinorelbine, Cisplatin)		Arm III (Gemcitabine, Cisplatin)		Arm IV (Topotecan, Cisplatin)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Arm I (Paclitaxel, Cisplatin)		Arm II (Vinorelbine, Cisplatin)		Arm III (Gemcitabine, Cisplatin)		Arm IV (Topotecan, Cisplatin)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	42/103 (40.8%)		39/108 (36.1%)		38/112 (33.9%)		38/111 (34.2%)
Blood and lymphatic system disorders
Leukopenia	0/103 (0%)		2/108 (1.9%)		1/112 (0.9%)		2/111 (1.8%)
Anemia	3/103 (2.9%)		1/108 (0.9%)		2/112 (1.8%)		3/111 (2.7%)
Thrombocytopenia	1/103 (1%)		0/108 (0%)		0/112 (0%)		0/111 (0%)
Neutropenia	3/103 (2.9%)		8/108 (7.4%)		2/112 (1.8%)		7/111 (6.3%)
Transfusion Prbc's	0/103 (0%)		1/108 (0.9%)		1/112 (0.9%)		0/111 (0%)
Cardiac disorders
Thrombosis Embolism	5/103 (4.9%)		9/108 (8.3%)		5/112 (4.5%)		3/111 (2.7%)
Ischemia/Cardiac Infarction	0/103 (0%)		1/108 (0.9%)		0/112 (0%)		0/111 (0%)
Sinus Tachycardia	0/103 (0%)		1/108 (0.9%)		0/112 (0%)		1/111 (0.9%)
Cardiac Left Ventricular Function	0/103 (0%)		0/108 (0%)		0/112 (0%)		1/111 (0.9%)
Hypotension	1/103 (1%)		2/108 (1.9%)		1/112 (0.9%)		0/111 (0%)
Other Cardiovascular	0/103 (0%)		0/108 (0%)		0/112 (0%)		2/111 (1.8%)
Gastrointestinal disorders
Nausea	2/103 (1.9%)		0/108 (0%)		1/112 (0.9%)		1/111 (0.9%)
Vomiting	4/103 (3.9%)		1/108 (0.9%)		0/112 (0%)		0/111 (0%)
Diarrhea Without Colostomy	0/103 (0%)		1/108 (0.9%)		0/112 (0%)		0/111 (0%)
Constipation	2/103 (1.9%)		0/108 (0%)		2/112 (1.8%)		0/111 (0%)
Dehydration	5/103 (4.9%)		2/108 (1.9%)		3/112 (2.7%)		1/111 (0.9%)
Anorexia	2/103 (1.9%)		0/108 (0%)		0/112 (0%)		1/111 (0.9%)
Ileus	1/103 (1%)		0/108 (0%)		0/112 (0%)		0/111 (0%)
Fistula Rectal/Anal	0/103 (0%)		1/108 (0.9%)		0/112 (0%)		0/111 (0%)
Proctitis	0/103 (0%)		0/108 (0%)		0/112 (0%)		1/111 (0.9%)
Diarrhea With Colostomy	1/103 (1%)		0/108 (0%)		0/112 (0%)		0/111 (0%)
Fistula Intestinal	1/103 (1%)		0/108 (0%)		0/112 (0%)		1/111 (0.9%)
Gi Other	0/103 (0%)		0/108 (0%)		0/112 (0%)		1/111 (0.9%)
General disorders
Fatigue	0/103 (0%)		0/108 (0%)		1/112 (0.9%)		0/111 (0%)
Fever(No Neutropenia)	0/103 (0%)		2/108 (1.9%)		2/112 (1.8%)		0/111 (0%)
Bone Pain	0/103 (0%)		0/108 (0%)		1/112 (0.9%)		1/111 (0.9%)
Abdominal Pain	3/103 (2.9%)		2/108 (1.9%)		1/112 (0.9%)		3/111 (2.7%)
Pain Rectal/Perirectal	1/103 (1%)		0/108 (0%)		0/112 (0%)		0/111 (0%)
Pain Other	1/103 (1%)		2/108 (1.9%)		1/112 (0.9%)		1/111 (0.9%)
Immune system disorders
Allergic Reaction	2/103 (1.9%)		0/108 (0%)		0/112 (0%)		0/111 (0%)
Infections and infestations
Febrile With Neutropenia	6/103 (5.8%)		2/108 (1.9%)		2/112 (1.8%)		2/111 (1.8%)
Infection Without Neutropenia	7/103 (6.8%)		4/108 (3.7%)		4/112 (3.6%)		5/111 (4.5%)
Infection With Grade 3/4 Neutropenia	1/103 (1%)		2/108 (1.9%)		0/112 (0%)		3/111 (2.7%)
Infection No Anc	1/103 (1%)		0/108 (0%)		0/112 (0%)		1/111 (0.9%)
Catheter-Related Infection	0/103 (0%)		0/108 (0%)		1/112 (0.9%)		0/111 (0%)
Infection Other	0/103 (0%)		1/108 (0.9%)		0/112 (0%)		0/111 (0%)
Other Infection	0/103 (0%)		3/108 (2.8%)		0/112 (0%)		0/111 (0%)
Metabolism and nutrition disorders
Hypokalemia	1/103 (1%)		0/108 (0%)		1/112 (0.9%)		1/111 (0.9%)
Hyperglycemia	0/103 (0%)		0/108 (0%)		1/112 (0.9%)		1/111 (0.9%)
Acidosis	0/103 (0%)		1/108 (0.9%)		0/112 (0%)		0/111 (0%)
Hyponatremia	1/103 (1%)		0/108 (0%)		0/112 (0%)		0/111 (0%)
Metabolic Other	0/103 (0%)		0/108 (0%)		1/112 (0.9%)		0/111 (0%)
Musculoskeletal and connective tissue disorders
Muscle Weakness	1/103 (1%)		0/108 (0%)		0/112 (0%)		0/111 (0%)
Musculoskeletal Other	0/103 (0%)		1/108 (0.9%)		0/112 (0%)		1/111 (0.9%)
Nervous system disorders
Ataxia(Incoordination)	1/103 (1%)		0/108 (0%)		0/112 (0%)		0/111 (0%)
Cns Cerebrovascular Ischemia	1/103 (1%)		0/108 (0%)		0/112 (0%)		0/111 (0%)
Speech Impairment	0/103 (0%)		0/108 (0%)		1/112 (0.9%)		0/111 (0%)
Renal and urinary disorders
Creatinine	1/103 (1%)		2/108 (1.9%)		2/112 (1.8%)		1/111 (0.9%)
Renal Failure	1/103 (1%)		2/108 (1.9%)		0/112 (0%)		0/111 (0%)
Fistula	0/103 (0%)		1/108 (0.9%)		0/112 (0%)		0/111 (0%)
Ureteral Obstruction	1/103 (1%)		2/108 (1.9%)		4/112 (3.6%)		4/111 (3.6%)
Renal/Gu Other	1/103 (1%)		0/108 (0%)		0/112 (0%)		0/111 (0%)
Other Genitourinary/Renal	0/103 (0%)		1/108 (0.9%)		0/112 (0%)		0/111 (0%)
Respiratory, thoracic and mediastinal disorders
Dyspnea	0/103 (0%)		0/108 (0%)		0/112 (0%)		3/111 (2.7%)
Pneumothorax	1/103 (1%)		0/108 (0%)		0/112 (0%)		0/111 (0%)
Pulmonary Other	0/103 (0%)		0/108 (0%)		1/112 (0.9%)		0/111 (0%)
Skin and subcutaneous tissue disorders
Wound Infectious	1/103 (1%)		0/108 (0%)		0/112 (0%)		0/111 (0%)
Skin Other	0/103 (0%)		0/108 (0%)		1/112 (0.9%)		0/111 (0%)
Vascular disorders
Prothrombin Time	0/103 (0%)		0/108 (0%)		0/112 (0%)		1/111 (0.9%)
Hemorrhage With Grade 3/4 Thrombocytopenia	0/103 (0%)		0/108 (0%)		1/112 (0.9%)		0/111 (0%)
Melena/Gi Bleeding	1/103 (1%)		0/108 (0%)		1/112 (0.9%)		1/111 (0.9%)
Vaginal Bleeding	0/103 (0%)		1/108 (0.9%)		2/112 (1.8%)		3/111 (2.7%)
Hemoptysis	0/103 (0%)		0/108 (0%)		1/112 (0.9%)		0/111 (0%)
Rectal Bleeding/Hematochezia	0/103 (0%)		0/108 (0%)		1/112 (0.9%)		0/111 (0%)
Other Hemorrhage	0/103 (0%)		0/108 (0%)		1/112 (0.9%)		0/111 (0%)
Other (Not Including Serious) Adverse Events
	Arm I (Paclitaxel, Cisplatin)		Arm II (Vinorelbine, Cisplatin)		Arm III (Gemcitabine, Cisplatin)		Arm IV (Topotecan, Cisplatin)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	101/103 (98.1%)		105/108 (97.2%)		109/112 (97.3%)		108/111 (97.3%)
Blood and lymphatic system disorders
Leukopenia	92/103 (89.3%)		98/108 (90.7%)		90/112 (80.4%)		102/111 (91.9%)
Anemia	94/103 (91.3%)		100/108 (92.6%)		104/112 (92.9%)		106/111 (95.5%)
Thrombocytopenia	36/103 (35%)		32/108 (29.6%)		88/112 (78.6%)		87/111 (78.4%)
Neutropenia	92/103 (89.3%)		94/108 (87%)		76/112 (67.9%)		102/111 (91.9%)
Otherhematologic	38/103 (36.9%)		53/108 (49.1%)		57/112 (50.9%)		57/111 (51.4%)
Lymphatics	1/103 (1%)		3/108 (2.8%)		2/112 (1.8%)		5/111 (4.5%)
Cardiac disorders
Thrombosis Embolism	5/103 (4.9%)		7/108 (6.5%)		2/112 (1.8%)		5/111 (4.5%)
Sinus Bradycardia	1/103 (1%)		0/108 (0%)		0/112 (0%)		0/111 (0%)
Cardiac Left Ventricular Function	1/103 (1%)		0/108 (0%)		1/112 (0.9%)		2/111 (1.8%)
Other Cardiovascular	22/103 (21.4%)		15/108 (13.9%)		11/112 (9.8%)		13/111 (11.7%)
Ear and labyrinth disorders
Inner Ear/Hearing	10/103 (9.7%)		14/108 (13%)		17/112 (15.2%)		11/111 (9.9%)
Other Hearing	2/103 (1.9%)		1/108 (0.9%)		2/112 (1.8%)		2/111 (1.8%)
Endocrine disorders
Endocrine	9/103 (8.7%)		4/108 (3.7%)		4/112 (3.6%)		5/111 (4.5%)
Eye disorders
Ocular	6/103 (5.8%)		5/108 (4.6%)		4/112 (3.6%)		8/111 (7.2%)
Gastrointestinal disorders
Nausea	62/103 (60.2%)		64/108 (59.3%)		59/112 (52.7%)		61/111 (55%)
Vomiting	59/103 (57.3%)		51/108 (47.2%)		57/112 (50.9%)		49/111 (44.1%)
Stomatitis/Pharyngitis	18/103 (17.5%)		10/108 (9.3%)		21/112 (18.8%)		13/111 (11.7%)
Other Gastrointestinal	65/103 (63.1%)		67/108 (62%)		75/112 (67%)		66/111 (59.5%)
General disorders
Fatigue	74/103 (71.8%)		82/108 (75.9%)		90/112 (80.4%)		85/111 (76.6%)
Other Constitutional	17/103 (16.5%)		23/108 (21.3%)		27/112 (24.1%)		28/111 (25.2%)
Myalgia	19/103 (18.4%)		9/108 (8.3%)		13/112 (11.6%)		12/111 (10.8%)
Other Pain	33/103 (32%)		47/108 (43.5%)		40/112 (35.7%)		40/111 (36%)
Hepatobiliary disorders
Hepatic	17/103 (16.5%)		13/108 (12%)		16/112 (14.3%)		20/111 (18%)
Immune system disorders
Allergic Reaction	10/103 (9.7%)		6/108 (5.6%)		4/112 (3.6%)		9/111 (8.1%)
Other Allergy	1/103 (1%)		4/108 (3.7%)		3/112 (2.7%)		3/111 (2.7%)
Infections and infestations
Febrile With Neutropenia	13/103 (12.6%)		15/108 (13.9%)		6/112 (5.4%)		11/111 (9.9%)
Infection Without Neutropenia	19/103 (18.4%)		12/108 (11.1%)		19/112 (17%)		9/111 (8.1%)
Other Infection	11/103 (10.7%)		12/108 (11.1%)		5/112 (4.5%)		13/111 (11.7%)
Metabolism and nutrition disorders
Metabolic	50/103 (48.5%)		50/108 (46.3%)		49/112 (43.8%)		48/111 (43.2%)
Musculoskeletal and connective tissue disorders
Musculoskeletal	6/103 (5.8%)		6/108 (5.6%)		9/112 (8%)		8/111 (7.2%)
Nervous system disorders
Neuropathy Sensor	37/103 (35.9%)		33/108 (30.6%)		21/112 (18.8%)		23/111 (20.7%)
Otherneurologic	27/103 (26.2%)		30/108 (27.8%)		28/112 (25%)		22/111 (19.8%)
Renal and urinary disorders
Creatinine	15/103 (14.6%)		18/108 (16.7%)		20/112 (17.9%)		16/111 (14.4%)
Other Genitourinary/Renal	10/103 (9.7%)		9/108 (8.3%)		6/112 (5.4%)		14/111 (12.6%)
Reproductive system and breast disorders
Sexual/Reproductive	0/103 (0%)		0/108 (0%)		2/112 (1.8%)		2/111 (1.8%)
Respiratory, thoracic and mediastinal disorders
Pulmonary	20/103 (19.4%)		16/108 (14.8%)		11/112 (9.8%)		17/111 (15.3%)
Skin and subcutaneous tissue disorders
Alopecia	65/103 (63.1%)		26/108 (24.1%)		22/112 (19.6%)		48/111 (43.2%)
Rash Desquamation	5/103 (4.9%)		3/108 (2.8%)		7/112 (6.3%)		7/111 (6.3%)
Other Dermatologic	15/103 (14.6%)		14/108 (13%)		11/112 (9.8%)		7/111 (6.3%)
Vascular disorders
Coagulation	0/103 (0%)		3/108 (2.8%)		1/112 (0.9%)		1/111 (0.9%)
Hemorrhage	6/103 (5.8%)		7/108 (6.5%)		10/112 (8.9%)		9/111 (8.1%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.