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

Primary Purpose

Lung Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
carboplatin
paclitaxel
conventional surgery
radiation therapy
Sponsored by
Fox Chase Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring stage II non-small cell lung cancer, stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Fox Chase Cancer Center - Philadelphia

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment

Arm Description

Thoracic RT (50.4 Gy/1.8 Gy Fx) Paclitaxel (50mg/m2/weekly X 6) Carboplatin (AUC 2/weekly X 6)

Outcomes

Primary Outcome Measures

Toxic Death Rate
Complete Resection Rates

Secondary Outcome Measures

Survival
Event-free Survival
Pathologic Complete Remission (pCR)

Full Information

First Posted
August 5, 2002
Last Updated
January 5, 2022
Sponsor
Fox Chase Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00043108
Brief Title
Combination Chemotherapy, Surgery, and Radiation Therapy in Treating Patients With Non-Small Cell Lung Cancer
Official Title
Trimodality Protocol for the Treatment of Locally Advanced, Potentially Resectable Non-Small Cell Lung Cancer Targeting
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
July 2002 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
February 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fox Chase Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
stage II non-small cell lung cancer, stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
Thoracic RT (50.4 Gy/1.8 Gy Fx) Paclitaxel (50mg/m2/weekly X 6) Carboplatin (AUC 2/weekly X 6)
Intervention Type
Drug
Intervention Name(s)
carboplatin
Intervention Type
Drug
Intervention Name(s)
paclitaxel
Intervention Type
Procedure
Intervention Name(s)
conventional surgery
Intervention Type
Radiation
Intervention Name(s)
radiation therapy
Primary Outcome Measure Information:
Title
Toxic Death Rate
Time Frame
5 years
Title
Complete Resection Rates
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Survival
Time Frame
5 years
Title
Event-free Survival
Time Frame
5 years
Title
Pathologic Complete Remission (pCR)
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aruna J. Turaka, MD
Organizational Affiliation
Fox Chase Cancer Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mark Hallman, MD
Organizational Affiliation
Fox Chase Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fox Chase Cancer Center - Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111-2497
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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