Combination Chemotherapy, Surgery, and Radiation Therapy in Treating Patients With Non-Small Cell Lung Cancer

• Sponsor: Fox Chase Cancer Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT00043108
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 19
• Location: 1
• Arm: 1
• Duration (Months): 187.1
• Patients Per Site Per Month: 0.1

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. Giving combination chemotherapy with radiation therapy before and after surgery may shrink the tumor so it can be removed during surgery and may kill any remaining tumor cells following surgery.

PURPOSE: Phase II trial to study the effectiveness of combining paclitaxel and carboplatin with radiation therapy and surgery in treating patients who have newly diagnosed locally advanced non-small cell lung cancer.

Condition or Disease	Intervention/Treatment	Phase
Lung Cancer	Drug: carboplatin; Drug: paclitaxel; Procedure: conventional surgery; Radiation: radiation therapy	Phase 2

Detailed Description

OBJECTIVES:

• Determine the complete resection rate and toxic death rate of patients with locally advanced non-small cell lung cancer treated with paclitaxel, carboplatin, and radiotherapy followed by surgical resection and adjuvant paclitaxel and carboplatin.

• Determine the survival, event-free survival, and incidence of pathologic complete remission of patients treated with this regimen.

• Determine the protocol completion rate (CR) of patients treated with this regimen.

• Determine the feasibility and toxicity of this regimen in these patients.

• Determine the pathologic response rate/downstaging, pathologic near CR rate, freedom from distant metastasis rate, and freedom from local regional failure rate of patients treated with this regimen.

OUTLINE: Patients receive induction therapy comprising radiotherapy 5 days a week for 5.5-6 weeks and paclitaxel IV over 1 hour and carboplatin IV over 30 minutes on days 1, 8, 15, 22, 29, and 36.

Within 1-3 weeks after completion of induction therapy, patients undergo restaging. Patients with resectable disease undergo surgical resection within 4-8 weeks after induction therapy. Patients with unresectable disease undergo additional radiotherapy 5 days a week for 3 weeks and receive paclitaxel and carboplatin as in induction therapy on days 1, 8, and 15.

Within 4-12 weeks after surgery or additional chemoradiotherapy, patients receive adjuvant therapy comprising paclitaxel and carboplatin as in induction therapy on day 1. Adjuvant treatment repeats every 4 weeks for 3 courses.

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

PROJECTED ACCRUAL: Approximately 57 patients will be accrued for this study within 4 years.

Study Design

• Study Type: Interventional
• Actual Enrollment: 19 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Trimodality Protocol for the Treatment of Locally Advanced, Potentially Resectable Non-Small Cell Lung Cancer Targeting
• Study Start Date: Jul 1, 2002
• Actual Primary Completion Date: Dec 1, 2016
• Actual Study Completion Date: Feb 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment Thoracic RT (50.4 Gy/1.8 Gy Fx) Paclitaxel (50mg/m2/weekly X 6) Carboplatin (AUC 2/weekly X 6)	Drug: carboplatin; Drug: paclitaxel; Procedure: conventional surgery; Radiation: radiation therapy

Outcome Measures

Primary Outcome Measures

1. Toxic Death Rate [5 years]

2. Complete Resection Rates [5 years]

Secondary Outcome Measures

1. Survival [5 years]

2. Event-free Survival [5 years]

3. Pathologic Complete Remission (pCR) [5 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 120 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed, newly diagnosed, unilateral primary non-small cell lung cancer (NSCLC)

• Must have involvement of the superior sulcus, chest wall, or mediastinum

• Must have at least 1 of the following:

• Locally advanced Pancoast tumors with no documented mediastinal or supraclavicular nodal involvement (T3-T4, N0-1)

• Resectable chest wall disease (T3, N0-1)

• Marginally resectable T4, N0-1, or NX central NSCLC

• N2 patients who are potentially resectable after induction chemoradiotherapy

• No evidence of extrathoracic spread to liver, adrenals, brain, or bone

• No evidence of supraclavicular nodes, malignant pleural or pericardial effusions, or distant metastases

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• Karnofsky 70-100%

Life expectancy

• Not specified

Hematopoietic

• Absolute neutrophil count at least 2,000/mm^3

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

Hepatic

• Bilirubin no greater than 1.5 mg/dL

• SGOT no greater than 3 times upper limit of normal

Renal

• Creatinine no greater than 2.0 mg/dL

Cardiovascular

• No superior vena cava syndrome

• No myocardial infarction within the past 6 months

• No active uncontrolled congestive heart failure

• No active uncontrolled arrhythmia within the past 6 months

Pulmonary

• FEV1 at least 800 mL

Other

• No other active invasive malignancy requiring therapy within the past 2 years

• No ongoing need for adjuvant therapy

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception during and for at least 3 months after study entry

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• Not specified

Endocrine therapy

• Not specified

Radiotherapy

• No prior pelvic or thoracic radiotherapy

Surgery

• See Disease Characteristics

Other

• Concurrent beta blockers, digitalis derivatives, or channel-blocking agents allowed provided cardiac conditions are stable

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fox Chase Cancer Center - Philadelphia	Philadelphia	Pennsylvania	United States	19111-2497

Sponsors and Collaborators

• Fox Chase Cancer Center
• National Cancer Institute (NCI)

Investigators

• Principal Investigator: Aruna J. Turaka, MD, Fox Chase Cancer Center
• Principal Investigator: Mark Hallman, MD, Fox Chase Cancer Center

Study Documents (Full-Text)

• Study Protocol, Statistical Analysis Plan, and Informed Consent Form - Jun 4, 2004

More Information

Publications

None provided.

• Responsible Party: Fox Chase Cancer Center
• ClinicalTrials.gov Identifier: NCT00043108
• Other Study ID Numbers: CDR0000256334; P30CA006927; NCI-G02-2097; 02-014
• First Posted: May 7, 2003
• Last Update Posted: Feb 3, 2022
• Last Verified: Jan 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Fox Chase Cancer Center: stage II non-small cell lung cancer; stage IIIA non-small cell lung cancer; stage IIIB non-small cell lung cancer
• Additional relevant MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Paclitaxel; Carboplatin

Study Results

Participant Flow

Arm/Group Title	Treatment
Arm/Group Description	Thoracic RT (50.4 Gy/1.8 Gy Fx) Paclitaxel (50mg/m2/weekly X 6) Carboplatin (AUC 2/weekly X 6) carboplatin paclitaxel conventional surgery radiation therapy
Period Title: Overall Study
STARTED	19
COMPLETED	19
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Treatment
Arm/Group Description	Thoracic RT (50.4 Gy/1.8 Gy Fx) Paclitaxel (50mg/m2/weekly X 6) Carboplatin (AUC 2/weekly X 6) carboplatin paclitaxel conventional surgery radiation therapy
Overall Participants	19
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	10 52.6%
>=65 years	9 47.4%
Sex: Female, Male (Count of Participants)
Female	9 47.4%
Male	10 52.6%
Race/Ethnicity, Customized (Count of Participants)
White Non-Hispanic	17 89.5%
Black or African American	2 10.5%
Region of Enrollment (participants) [Number]
United States	19 100%

Outcome Measures

1. Primary Outcome

Title	Toxic Death Rate
Time Frame	5 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Treatment
Arm/Group Description	Thoracic RT (50.4 Gy/1.8 Gy Fx) Paclitaxel (50mg/m2/weekly X 6) Carboplatin (AUC 2/weekly X 6) carboplatin paclitaxel conventional surgery radiation therapy
Measure Participants	19
Count of Participants [Participants]	NA NaN

2. Primary Outcome

Title	Complete Resection Rates
Time Frame	5 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Treatment
Arm/Group Description	Thoracic RT (50.4 Gy/1.8 Gy Fx) Paclitaxel (50mg/m2/weekly X 6) Carboplatin (AUC 2/weekly X 6) carboplatin paclitaxel conventional surgery radiation therapy
Measure Participants	19
Count of Participants [Participants]	NA NaN

3. Secondary Outcome

Title	Survival
Time Frame	5 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Treatment
Arm/Group Description	Thoracic RT (50.4 Gy/1.8 Gy Fx) Paclitaxel (50mg/m2/weekly X 6) Carboplatin (AUC 2/weekly X 6) carboplatin paclitaxel conventional surgery radiation therapy
Measure Participants	19
Median (95% Confidence Interval) [months]	NA

4. Secondary Outcome

Title	Event-free Survival
Time Frame	5 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Treatment
Arm/Group Description	Thoracic RT (50.4 Gy/1.8 Gy Fx) Paclitaxel (50mg/m2/weekly X 6) Carboplatin (AUC 2/weekly X 6) carboplatin paclitaxel conventional surgery radiation therapy
Measure Participants	19
Median (95% Confidence Interval) [months]	NA

5. Secondary Outcome

Title	Pathologic Complete Remission (pCR)
Time Frame	5 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Treatment
Arm/Group Description	Thoracic RT (50.4 Gy/1.8 Gy Fx) Paclitaxel (50mg/m2/weekly X 6) Carboplatin (AUC 2/weekly X 6) carboplatin paclitaxel conventional surgery radiation therapy
Measure Participants	19
Count of Participants [Participants]	NA NaN

Adverse Events

Time Frame	5 years
Adverse Event Reporting Description	The PI has left the institution and the only access to the data is from publications. The access to this specific information/data cannot be confirmed and/or is not available to be reported.
Arm/Group Title	Treatment
Arm/Group Description	Thoracic RT (50.4 Gy/1.8 Gy Fx) Paclitaxel (50mg/m2/weekly X 6) Carboplatin (AUC 2/weekly X 6) carboplatin paclitaxel conventional surgery radiation therapy
All Cause Mortality
	Treatment
	Affected / at Risk (%)	# Events
Total	14/19 (73.7%)
Serious Adverse Events
	Treatment
	Affected / at Risk (%)	# Events
Total	0/19 (0%)
Other (Not Including Serious) Adverse Events
	Treatment
	Affected / at Risk (%)	# Events
Total	0/19 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.