Chemotherapy, Surgery, and Radiation Therapy in Treating Patients With Gastric Cancer

• Sponsor: ECOG-ACRIN Cancer Research Group (Other)
• Overall Status: Completed
• CT.gov ID: NCT00003298
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 39
• Locations: 30
• Arm: 1
• Duration (Months): 146.9
• Patients Per Site: 1.3
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy, radiation therapy, and surgery may kill more tumor cells. E7296 was conducted to study neoadjuvant chemotherapy and postoperative chemoradiation therapy in patients diagnosed with high-risk gastric cancer using a new neoadjuvant regimen: paclitaxel plus cisplatin. It was hypothesized that this new neoadjuvant chemotherapy followed by surgery and chemoradiation therapy would be well tolerated and would have a high curative resection rate.

Condition or Disease	Intervention/Treatment	Phase
Gastric Cancer	Drug: cisplatin; Drug: fluorouracil; Drug: leucovorin calcium; Drug: paclitaxel; Procedure: surgery; Radiation: radiation therapy	Phase 2

Detailed Description

OBJECTIVES:

Primary objective: To evaluate the tolerability and toxicity of neoadjuvant cisplatin plus paclitaxel and postoperative chemoradiation therapy with fluorouracil plus leucovorin calcium in patients with high-risk gastric cancer.

Secondary objectives: To assess the pathologic response of gastric tumors to neoadjuvant cisplatin plus paclitaxel chemotherapy, and preliminarily assess the patterns of failure and disease free and overall survival.

OUTLINE: Patients receive 3 courses of preoperative neoadjuvant chemotherapy given on day 1 every 21 days. Courses consist of an intravenous infusion of cisplatin and a 3 hour intravenous infusion of paclitaxel on day 1. Patients then undergo surgery for tumor removal on day 63, followed 4-6 weeks later by one course of daily intravenous bolus leucovorin calcium and fluorouracil for 5 days. Chemotherapy is repeated 4-6 weeks later for the first 4 days of week 1 and the last 3 days of week 5 of radiation therapy given 5 days a week for 5 weeks. Patients receive two more courses, 4 weeks apart, of fluorouracil and leucovorin calcium for 5 days 4-6 weeks after completing radiation treatment. Patients are followed every month for the first 3 months, every 3 months for the next 21 months, every 6 months for the next year, and annually thereafter.

PROJECTED ACCRUAL: Approximately 30-42 patients will be accrued over 18 months.

Study Design

• Study Type: Interventional
• Actual Enrollment: 39 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase II Trial of Neoadjuvant Paclitaxel - Cisplatin Chemotherapy, Surgery and Adjuvant Radiation Therapy and 5-FU/Leucovorin for Gastric Cancer
• Study Start Date: Feb 1, 1999
• Actual Primary Completion Date: Feb 1, 2010
• Actual Study Completion Date: May 1, 2011

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Experimental Arm Patients receive 3 courses of preoperative neoadjuvant chemotherapy given on day 1 every 21 days. Courses consist of an intravenous infusion of cisplatin and a 3 hour intravenous infusion of paclitaxel on day 1. Patients then undergo surgery for tumor removal on day 63, followed 4-6 weeks later by one course of daily intravenous bolus leucovorin calcium and fluorouracil for 5 days. Chemotherapy is repeated 4-6 weeks later for the first 4 days of week 1 and the last 3 days of week 5 of radiation therapy given 5 days a week for 5 weeks. Patients receive two more courses, 4 weeks apart, of fluorouracil and leucovorin calcium for 5 days 4-6 weeks after completing radiation treatment.

Drug: cisplatin; Cisplatin was administered as part of the neoadjuvant regimen. It was given at a dose of 75 mg/m² via IV over approximately one hour, on day 1 of each cycle. Three cycles were given.; Other Names: Platinol cis-platinum cisdiamminedichloroplatinum (II) Platinol-AQ DACP platinum CDDP DDP ; Drug: fluorouracil; Postoperative regimen 5-FU, along with Leucovorin, was given by IV bolus, with 5-FU given immediately after the Leucovorin; Other Names: 5-Fluorouracil 5-FU Adrucil Efudex ; Drug: leucovorin calcium; Both 5-FU and Leucovorin will be given via IV bolus, with Leucovorin given immediately before 5-FU.; Other Names: Leucovorin Wellcovorin citrovorum factor folinic acid 5-formyl tetrahydrofolate LV LCV ; Drug: paclitaxel; Paclitaxel was administered as part of the neoadjuvant regimen. It was given at a dose of 175 mg/m² as a 3 hour continuous intravenous infusion on day 1. Three cycles were given.; Other Names: Taxol® NSC 125973 ; Procedure: surgery; The surgical procedure performed involved a radical subtotal or total gastrectomy. A complete surgical resection was required; Radiation: radiation therapy; Concomitant chemotherapy and radiation therapy course: 5-FU 400 mg/m²/day + Leucovorin 20 mg/m²/day on days 1-4 of week one and days 1-3 of week 5 of XRT. Combined chemotherapy and radiation therapy were to begin 4 weeks after day 1 of the initial course of chemotherapy

Outcome Measures

Primary Outcome Measures

1. Grade 3 or Higher Toxicity Incidence on Step 1 [assessed at the end of every cycle (cycle=21 days) during treatment (3 cycles in total)]

   Incidence is defined as proportion of patients with any grade 3 or higher treatment-related toxicities among all treated patients.

Secondary Outcome Measures

1. Best Confirmed Response to Neoadjuvant Therapy [Assessed at surgery time (surgery performed during week 8-10 after registration to the study)]

   Response was based on pathology at surgery. A patient achieved complete response if no gross or microscopic tumor were identified with the surgical specimen and nodal tissue. Stable response was defined as a response that did not qualify as complete response or progressive disease (PD), where PD indicated metastatic spread. Best confirmed response rate was defined as the proportion of patients with complete response (CR). A patient was considered unevaluable if the patient did not have surgery, the pathologist did not examine at least 15 lymph nodes, or the pathology report was unavailable.

2. Overall Survival [assessed every month for the first 3 months, every 3 months for the next 21 months, every 6 months for the next year, and annually thereafter up to year 10]

   Overall survival was defined as the time from registration to death, where a subject was censored on date of last record alive.

3. Progression Free Survival [assessed every month for the first 3 months, every 3 months for the next 21 months, every 6 months for the next year, and annually thereafter up to year 10]

   Progression-free survival (PFS) was defined as time from registration until progression, recurrence, or death, whichever occurred first. If date of death occurred beyond three months from the date of last disease assessment, then PFS was censored at date of last disease assessment. Patients who were alive and progression-free were censored at the date of last disease evaluation.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction

• Localized cancer that is potentially curable by surgery (T2, N1-2, M0 or T3-4, any N, M0)

• No metastatic cancer to the ovaries

• Age: 18 and over

• Easter Cooperative Oncology Group (ECOG) performance status 0-2

• White blood cell (WBC) count at least 4,000 cells/mm3

• Platelet count at least 150,000/mm3

• Bilirubin less than 2 mg/dL

• Creatinine no greater than 1.5 mg/dL

• Creatinine clearance greater than 50 mL/min

• Caloric intake must be at least 1500 kcal/day

• No prior history of cancer within the past 5 years except for basal cell carcinoma of the skin or in situ carcinoma of the cervix

• No prior radiation therapy, except for skin cancer

• Fertile patients must use adequate contraception

• Met criteria for re-registration after surgery

• T1N1-2M0, T2N1-2M0 or T3-4NanyM0 at time of initial re-registration.

• No evidence of metastatic disease from postoperative pathologic staging.

• ECOG performance status of 0, 1, or 2 at re-registration

• Curative resection performed

• Re-registered 4 - 6 weeks from the date of surgery

• WBC ≥ 4000 cells/mm³, platelets ≥ 150,000/mm³, creatinine ≤ 1.5 mg/dl or creatinine clearance of > 50 ml/min (measured or calculated) and total serum bilirubin < 2 mg/dl, all within four weeks prior to re-registration

Exclusion Criteria:

• Prior chemotherapy

• Clinically significant auditory impairment

• Significant heart disease

• Pregnant or lactating

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CCOP - Colorado Cancer Research Program, Inc.	Denver	Colorado	United States	80209-5031
2	Emory University Hospital - Atlanta	Atlanta	Georgia	United States	30322
3	Robert H. Lurie Comprehensive Cancer Center, Northwestern University	Chicago	Illinois	United States	60611-3013
4	Veterans Affairs Medical Center - Lakeside Chicago	Chicago	Illinois	United States	60611
5	CCOP - Evanston	Evanston	Illinois	United States	60201
6	CCOP - Carle Cancer Center	Urbana	Illinois	United States	61801
7	Indiana University Cancer Center	Indianapolis	Indiana	United States	46202-5289
8	Veterans Affairs Medical Center - Indianapolis (Roudebush)	Indianapolis	Indiana	United States	46202
9	CCOP - Cedar Rapids Oncology Project	Cedar Rapids	Iowa	United States	52403-1206
10	CCOP - Ochsner	New Orleans	Louisiana	United States	70121
11	New England Medical Center Hospital	Boston	Massachusetts	United States	02111
12	CCOP - Ann Arbor Regional	Ann Arbor	Michigan	United States	48106
13	CCOP - Kalamazoo	Kalamazoo	Michigan	United States	49007-3731
14	CCOP - Metro-Minnesota	Saint Louis Park	Minnesota	United States	55416
15	CCOP - Missouri Valley Cancer Consortium	Omaha	Nebraska	United States	68131
16	Morristown Memorial Hospital	Morristown	New Jersey	United States	07962-1956
17	Cancer Institute of New Jersey	New Brunswick	New Jersey	United States	08901
18	Raritan Bay Medical Center	Perth Amboy	New Jersey	United States	08861
19	Somerset Medical Center	Somerville	New Jersey	United States	08876
20	Albert Einstein Comprehensive Cancer Center	Bronx	New York	United States	10461
21	University of Rochester Cancer Center	Rochester	New York	United States	14642
22	Ireland Cancer Center	Cleveland	Ohio	United States	44106-5065
23	CCOP - Toledo Community Hospital Oncology Program	Toledo	Ohio	United States	43623-3456
24	University of Pennsylvania Cancer Center	Philadelphia	Pennsylvania	United States	19104-4283
25	CCOP - MainLine Health	Wynnewood	Pennsylvania	United States	19096
26	Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville Campus	Nashville	Tennessee	United States	37212
27	Vanderbilt-Ingram Cancer Center	Nashville	Tennessee	United States	37232-6838
28	CCOP - Marshfield Medical Research and Education Foundation	Marshfield	Wisconsin	United States	54449
29	Medical College of Wisconsin	Milwaukee	Wisconsin	United States	53226
30	Veterans Affairs Medical Center - Milwaukee (Zablocki)	Milwaukee	Wisconsin	United States	53295

Sponsors and Collaborators

• ECOG-ACRIN Cancer Research Group
• National Cancer Institute (NCI)

Investigators

• Study Chair: David I. Rosenthal, MD, Abramson Cancer Center of the University of Pennsylvania

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: ECOG-ACRIN Cancer Research Group
• ClinicalTrials.gov Identifier: NCT00003298
• Other Study ID Numbers: CDR0000066237; E7296; U10CA023318
• First Posted: Jan 23, 2004
• Last Update Posted: Jul 16, 2015
• Last Verified: Jun 1, 2015

• Keywords provided by ECOG-ACRIN Cancer Research Group: stage II gastric cancer; stage III gastric cancer; stage IV gastric cancer; adenocarcinoma of the stomach
• Additional relevant MeSH terms: Stomach Neoplasms; Leucovorin; Formyltetrahydrofolates; Tetrahydrofolates; Paclitaxel; Cisplatin; Fluorouracil; Calcium; Levoleucovorin

Study Results

Participant Flow

Recruitment Details	E7296 was activated on February 25, 1999 and terminated on March 18, 2002 with a final accrual of 39 patients (accrual goal: 42 patients) enrolled by 13 ECOG affiliated institutions.

Arm/Group Title	Experimental Arm
Arm/Group Description	Patients receive 3 courses of preoperative neoadjuvant chemotherapy (an intravenous infusion of cisplatin and a 3 hour intravenous infusion of paclitaxel) given on day 1 every 21 days. Patients then undergo surgery for tumor removal on day 63, followed 4-6 weeks later by one course of daily intravenous bolus leucovorin calcium and fluorouracil for 5 days. Chemotherapy is repeated 4-6 weeks later for the first 4 days of week 1 and the last 3 days of week 5 of radiation therapy given 5 days a week for 5 weeks. Patients receive two more courses, 4 weeks apart, of fluorouracil and leucovorin calcium for 5 days 4-6 weeks after completing radiation treatment.
Period Title: Step 1 (Neoadjuvant Therapy)
STARTED	39
Eligible and Treated	38
Complete 3 Cycles of Neoadjuvant Therapy	35
COMPLETED	35
NOT COMPLETED	4
Period Title: Step 1 (Neoadjuvant Therapy)
STARTED	35
COMPLETED	28
NOT COMPLETED	7
Period Title: Step 1 (Neoadjuvant Therapy)
STARTED	28
COMPLETED	10
NOT COMPLETED	18
Period Title: Step 1 (Neoadjuvant Therapy)
STARTED	10
Eligible and Treated on Step 2	7
COMPLETED	4
NOT COMPLETED	6

Baseline Characteristics

Arm/Group Title	Experimental Arm
Arm/Group Description	Patients receive 3 courses of preoperative neoadjuvant chemotherapy (an intravenous infusion of cisplatin and a 3 hour intravenous infusion of paclitaxel) given on day 1 every 21 days. Patients then undergo surgery for tumor removal on day 63, followed 4-6 weeks later by one course of daily intravenous bolus leucovorin calcium and fluorouracil for 5 days. Chemotherapy is repeated 4-6 weeks later for the first 4 days of week 1 and the last 3 days of week 5 of radiation therapy given 5 days a week for 5 weeks. Patients receive two more courses, 4 weeks apart, of fluorouracil and leucovorin calcium for 5 days 4-6 weeks after completing radiation treatment.
Overall Participants	38
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	57
Sex: Female, Male (Count of Participants)
Female	13 34.2%
Male	25 65.8%
Region of Enrollment (participants) [Number]
United States	38 100%

Outcome Measures

1. Secondary Outcome

Title	Best Confirmed Response to Neoadjuvant Therapy
Description	Response was based on pathology at surgery. A patient achieved complete response if no gross or microscopic tumor were identified with the surgical specimen and nodal tissue. Stable response was defined as a response that did not qualify as complete response or progressive disease (PD), where PD indicated metastatic spread. Best confirmed response rate was defined as the proportion of patients with complete response (CR). A patient was considered unevaluable if the patient did not have surgery, the pathologist did not examine at least 15 lymph nodes, or the pathology report was unavailable.
Time Frame	Assessed at surgery time (surgery performed during week 8-10 after registration to the study)

Outcome Measure Data

Analysis Population Description

Eligible and treated patients on step 1. Since no patient had a complete response in the study, one-sided 95% confidence interval was provided here.

Arm/Group Title	Experimental Arm
Arm/Group Description	Patients receive 3 courses of preoperative neoadjuvant chemotherapy (an intravenous infusion of cisplatin and a 3 hour intravenous infusion of paclitaxel) given on day 1 every 21 days. Patients then undergo surgery for tumor removal on day 63, followed 4-6 weeks later by one course of daily intravenous bolus leucovorin calcium and fluorouracil for 5 days. Chemotherapy is repeated 4-6 weeks later for the first 4 days of week 1 and the last 3 days of week 5 of radiation therapy given 5 days a week for 5 weeks. Patients receive two more courses, 4 weeks apart, of fluorouracil and leucovorin calcium for 5 days 4-6 weeks after completing radiation treatment.
Measure Participants	38
Number (95% Confidence Interval) [percentage of participants]	0 0%

2. Primary Outcome

Title	Grade 3 or Higher Toxicity Incidence on Step 1
Description	Incidence is defined as proportion of patients with any grade 3 or higher treatment-related toxicities among all treated patients.
Time Frame	assessed at the end of every cycle (cycle=21 days) during treatment (3 cycles in total)

Outcome Measure Data

Analysis Population Description

eligible and treated patients on step 1

Arm/Group Title	Experimental Arm
Arm/Group Description	Patients receive 3 courses of preoperative neoadjuvant chemotherapy (an intravenous infusion of cisplatin and a 3 hour intravenous infusion of paclitaxel) given on day 1 every 21 days. Patients then undergo surgery for tumor removal on day 63, followed 4-6 weeks later by one course of daily intravenous bolus leucovorin calcium and fluorouracil for 5 days. Chemotherapy is repeated 4-6 weeks later for the first 4 days of week 1 and the last 3 days of week 5 of radiation therapy given 5 days a week for 5 weeks. Patients receive two more courses, 4 weeks apart, of fluorouracil and leucovorin calcium for 5 days 4-6 weeks after completing radiation treatment.
Measure Participants	38
Number (95% Confidence Interval) [percentage of participants]	65.8 173.2%

3. Secondary Outcome

Title	Overall Survival
Description	Overall survival was defined as the time from registration to death, where a subject was censored on date of last record alive.
Time Frame	assessed every month for the first 3 months, every 3 months for the next 21 months, every 6 months for the next year, and annually thereafter up to year 10

Outcome Measure Data

Analysis Population Description

eligible and treated patients on step 1

Arm/Group Title	Experimental Arm
Arm/Group Description	Patients receive 3 courses of preoperative neoadjuvant chemotherapy (an intravenous infusion of cisplatin and a 3 hour intravenous infusion of paclitaxel) given on day 1 every 21 days. Patients then undergo surgery for tumor removal on day 63, followed 4-6 weeks later by one course of daily intravenous bolus leucovorin calcium and fluorouracil for 5 days. Chemotherapy is repeated 4-6 weeks later for the first 4 days of week 1 and the last 3 days of week 5 of radiation therapy given 5 days a week for 5 weeks. Patients receive two more courses, 4 weeks apart, of fluorouracil and leucovorin calcium for 5 days 4-6 weeks after completing radiation treatment.
Measure Participants	38
Median (90% Confidence Interval) [years]	1.55

4. Secondary Outcome

Title	Progression Free Survival
Description	Progression-free survival (PFS) was defined as time from registration until progression, recurrence, or death, whichever occurred first. If date of death occurred beyond three months from the date of last disease assessment, then PFS was censored at date of last disease assessment. Patients who were alive and progression-free were censored at the date of last disease evaluation.
Time Frame	assessed every month for the first 3 months, every 3 months for the next 21 months, every 6 months for the next year, and annually thereafter up to year 10

Outcome Measure Data

Analysis Population Description

eligible and treated patients on step 1

Arm/Group Title	Experimental Arm
Arm/Group Description	Patients receive 3 courses of preoperative neoadjuvant chemotherapy (an intravenous infusion of cisplatin and a 3 hour intravenous infusion of paclitaxel) given on day 1 every 21 days. Patients then undergo surgery for tumor removal on day 63, followed 4-6 weeks later by one course of daily intravenous bolus leucovorin calcium and fluorouracil for 5 days. Chemotherapy is repeated 4-6 weeks later for the first 4 days of week 1 and the last 3 days of week 5 of radiation therapy given 5 days a week for 5 weeks. Patients receive two more courses, 4 weeks apart, of fluorouracil and leucovorin calcium for 5 days 4-6 weeks after completing radiation treatment.
Measure Participants	38
Median (90% Confidence Interval) [years]	0.68

Adverse Events

Time Frame	Assessed every cycle while on treatment and for 30 days after the end of treatment
Arm/Group Title	Step 1(Neoadjuvant Therapy)		Step 2 (Adjuvant Therapy)
Arm/Group Description	Patients receive 3 courses of preoperative neoadjuvant chemotherapy given on day 1 every 21 days. Courses consist of an intravenous infusion of cisplatin and a 3 hour intravenous infusion of paclitaxel on day 1.		After neoadjuvant therapy, patients undergo surgery for tumor removal on day 63, followed 4-6 weeks later by one course of daily intravenous bolus leucovorin calcium and fluorouracil for 5 days. Chemotherapy is repeated 4-6 weeks later for the first 4 days of week 1 and the last 3 days of week 5 of radiation therapy given 5 days a week for 5 weeks. Patients receive two more courses, 4 weeks apart, of fluorouracil and leucovorin calcium for 5 days 4-6 weeks after completing radiation treatment.
All Cause Mortality
	Step 1(Neoadjuvant Therapy)		Step 2 (Adjuvant Therapy)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Step 1(Neoadjuvant Therapy)		Step 2 (Adjuvant Therapy)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	25/38 (65.8%)		6/7 (85.7%)
Blood and lymphatic system disorders
Febrile neutropenia	0/38 (0%)		2/7 (28.6%)
Cardiac disorders
Ventricular arrhythmia	1/38 (2.6%)		0/7 (0%)
Gastrointestinal disorders
Constipation	1/38 (2.6%)		0/7 (0%)
Esophagitis	0/38 (0%)		2/7 (28.6%)
Nausea	1/38 (2.6%)		2/7 (28.6%)
Mucositis oral	0/38 (0%)		1/7 (14.3%)
Vomiting	1/38 (2.6%)		3/7 (42.9%)
Diarrhea	0/38 (0%)		2/7 (28.6%)
Immune system disorders
Anaphylaxis	1/38 (2.6%)		0/7 (0%)
Infections and infestations
Catheter related infection	0/38 (0%)		1/7 (14.3%)
Infection with grade 3 or 4 neutropenia	0/38 (0%)		1/7 (14.3%)
Investigations
White blood cell decreased	4/38 (10.5%)		3/7 (42.9%)
Neutrophil count decreased	18/38 (47.4%)		5/7 (71.4%)
Platelet count decreased	1/38 (2.6%)		1/7 (14.3%)
Weight loss	0/38 (0%)		1/7 (14.3%)
Alkaline phosphatase increased	1/38 (2.6%)		0/7 (0%)
Creatinine increased	1/38 (2.6%)		0/7 (0%)
Metabolism and nutrition disorders
Anorexia	1/38 (2.6%)		2/7 (28.6%)
Dehydration	3/38 (7.9%)		2/7 (28.6%)
Hypoalbuminemia	0/38 (0%)		1/7 (14.3%)
Hyperkalemia	1/38 (2.6%)		0/7 (0%)
Hypocalcemia	2/38 (5.3%)		0/7 (0%)
Hypokalemia	3/38 (7.9%)		0/7 (0%)
Hypomagnesemia	2/38 (5.3%)		0/7 (0%)
Hyponatremia	0/38 (0%)		1/7 (14.3%)
Hypophosphatemia	0/38 (0%)		1/7 (14.3%)
Musculoskeletal and connective tissue disorders
Arthralgia	1/38 (2.6%)		0/7 (0%)
Myalgia	2/38 (5.3%)		0/7 (0%)
Nervous system disorders
Depressed level of consciousness	0/38 (0%)		1/7 (14.3%)
Dizziness	1/38 (2.6%)		0/7 (0%)
Syncope	1/38 (2.6%)		0/7 (0%)
Psychiatric disorders
Confusion	1/38 (2.6%)		0/7 (0%)
Depression	0/38 (0%)		1/7 (14.3%)
Vascular disorders
Hypotension	1/38 (2.6%)		0/7 (0%)
Other (Not Including Serious) Adverse Events
	Step 1(Neoadjuvant Therapy)		Step 2 (Adjuvant Therapy)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	38/38 (100%)		7/7 (100%)
Blood and lymphatic system disorders
Anemia	3/38 (7.9%)		2/7 (28.6%)
Cardiac disorders
Cardiac disorders - Other	2/38 (5.3%)		0/7 (0%)
Ear and labyrinth disorders
Hearing impaired	3/38 (7.9%)		0/7 (0%)
Eye disorders
Watering eyes	2/38 (5.3%)		0/7 (0%)
Gastrointestinal disorders
Constipation	5/38 (13.2%)		0/7 (0%)
Dyspepsia	2/38 (5.3%)		0/7 (0%)
Dysphagia	0/38 (0%)		1/7 (14.3%)
Dry mouth	0/38 (0%)		1/7 (14.3%)
Nausea	29/38 (76.3%)		6/7 (85.7%)
Mucositis oral	5/38 (13.2%)		3/7 (42.9%)
Vomiting	20/38 (52.6%)		2/7 (28.6%)
Diarrhea	16/38 (42.1%)		2/7 (28.6%)
Diarrhea	0/38 (0%)		1/7 (14.3%)
Gastrointestinal disorders - Other	3/38 (7.9%)		0/7 (0%)
General disorders
Fatigue	28/38 (73.7%)		5/7 (71.4%)
Fever	2/38 (5.3%)		0/7 (0%)
Pain	2/38 (5.3%)		1/7 (14.3%)
Injury, poisoning and procedural complications
Dermatitis radiation	0/38 (0%)		2/7 (28.6%)
Investigations
White blood cell decreased	29/38 (76.3%)		7/7 (100%)
Neutrophil count decreased	16/38 (42.1%)		5/7 (71.4%)
Platelet count decreased	9/38 (23.7%)		4/7 (57.1%)
Weight loss	2/38 (5.3%)		4/7 (57.1%)
Alkaline phosphatase increased	5/38 (13.2%)		2/7 (28.6%)
Blood bilirubin increased	3/38 (7.9%)		2/7 (28.6%)
Aspartate aminotransferase increased	3/38 (7.9%)		0/7 (0%)
Alanine aminotransferase increased	0/38 (0%)		1/7 (14.3%)
Creatinine increased	7/38 (18.4%)		0/7 (0%)
Metabolism and nutrition disorders
Anorexia	13/38 (34.2%)		2/7 (28.6%)
Dehydration	5/38 (13.2%)		1/7 (14.3%)
Hypoalbuminemia	0/38 (0%)		1/7 (14.3%)
Hyperglycemia	2/38 (5.3%)		1/7 (14.3%)
Hypocalcemia	3/38 (7.9%)		1/7 (14.3%)
Hypokalemia	2/38 (5.3%)		0/7 (0%)
Hypomagnesemia	4/38 (10.5%)		1/7 (14.3%)
Hyponatremia	0/38 (0%)		1/7 (14.3%)
Hypophosphatemia	0/38 (0%)		1/7 (14.3%)
Musculoskeletal and connective tissue disorders
Generalized muscle weakness	2/38 (5.3%)		0/7 (0%)
Arthralgia	2/38 (5.3%)		0/7 (0%)
Myalgia	8/38 (21.1%)		0/7 (0%)
Nervous system disorders
Dysgeusia	4/38 (10.5%)		2/7 (28.6%)
Dizziness	6/38 (15.8%)		1/7 (14.3%)
Peripheral motor neuropathy	2/38 (5.3%)		0/7 (0%)
Peripheral sensory neuropathy	13/38 (34.2%)		0/7 (0%)
Headache	3/38 (7.9%)		0/7 (0%)
Psychiatric disorders
Anxiety	3/38 (7.9%)		0/7 (0%)
Depression	0/38 (0%)		1/7 (14.3%)
Skin and subcutaneous tissue disorders
Alopecia	20/38 (52.6%)		4/7 (57.1%)
Nail loss	2/38 (5.3%)		0/7 (0%)
Pruritus	3/38 (7.9%)		0/7 (0%)
Vascular disorders
Hypotension	2/38 (5.3%)		1/7 (14.3%)

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.