Lung Cancer
Conditions
Keywords
stage II non-small cell lung cancer, stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer
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.
Interventions
DRUGcarboplatin
DRUGpaclitaxel
PROCEDUREconventional surgery
RADIATIONradiation therapy
Sponsors
National Cancer Institute (NCI)
Fox Chase Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Toxic Death Rate | 5 years |
| Complete Resection Rates | 5 years |
Secondary
| Measure | Time frame |
|---|---|
| Survival | 5 years |
| Event-free Survival | 5 years |
| Pathologic Complete Remission (pCR) | 5 years |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treatment 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 | 19 |
| Total | 19 |
Baseline characteristics
| Characteristic | Treatment |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 9 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants |
| Race/Ethnicity, Customized Black or African American | 2 Participants |
| Race/Ethnicity, Customized White Non-Hispanic | 17 Participants |
| Region of Enrollment United States | 19 participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 14 / 19 |
| other Total, other adverse events | 0 / 19 |
| serious Total, serious adverse events | 0 / 19 |
Outcome results
Primary
Complete Resection Rates
Time frame: 5 years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment | Complete Resection Rates | NA Participants |
Primary
Toxic Death Rate
Time frame: 5 years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment | Toxic Death Rate | NA Participants |
Secondary
Event-free Survival
Time frame: 5 years
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Treatment | Event-free Survival | NA months |
Secondary
Pathologic Complete Remission (pCR)
Time frame: 5 years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment | Pathologic Complete Remission (pCR) | NA Participants |
Secondary
Survival
Time frame: 5 years
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Treatment | Survival | NA months |