Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Non-Small Cell Lung Cancer
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 and radiation therapy may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of radiation therapy when given with combination chemotherapy and to see how well they work in treating patients with non-small cell lung cancer that cannot be surgically removed.
Radiation: radiation therapy
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Phase I/II Study Of Concurrent Chemotherapy And Escalating Doses Of Radiotherapy (RT) For Unresectable Non-Small Cell Lung Cancer (NSCLC) Using A New RT Paradigm|
- Maximum tolerated dose (MTD) as assessed by dose-limiting toxicity within 1 month after completion of study treatment (phase I) [ Designated as safety issue: Yes ]
- Survival at 2 years (phase II) [ Designated as safety issue: No ]
- Survival time, time to disease progression, and time to local progression as assessed by clinical measures based on H&P after completion of study treatment [ Designated as safety issue: No ]
- Toxicity [ Designated as safety issue: Yes ]
|Study Start Date:||May 2002|
|Primary Completion Date:||January 2010 (Final data collection date for primary outcome measure)|
- Determine the maximum tolerated dose of radiotherapy in combination with carboplatin and paclitaxel in patients with unresectable non-small cell lung cancer.
- Determine the 2-year survival of patients treated with this regimen.
- Determine the progression-free local control rate in patients treated this regimen.
- Determine the tolerability of this regimen in these patients.
- Assess the quality of life of patients treated with this regimen.
OUTLINE: This is a multicenter, dose-escalation study of radiotherapy.
Patients undergo radiotherapy* once daily 5 days a week for 7 weeks and 2 days (a total of 37 fractions). Patients concurrently receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes once weekly for 7 weeks. Treatment continutes in the absence of disease progression or unacceptable toxicity.
NOTE: *No prophylactic nodal radiotherapy is administered
Cohorts of 3-6 patients receive escalating doses of radiotherapy until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, 12 additional patients are treated at that dose level in the phase II portion of the study.
Beginning 3 weeks after completion of radiotherapy, patients receive paclitaxel and carboplatin as above. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, once during the last week of radiotherapy, and then every 3 months for 2 years.
Patients are followed at 3 weeks, every 3 months for 21 months, and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 90 patients will be accrued for this study.