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
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 69
- Locations
- 51
- Primary Endpoint
- Maximum tolerated dose (MTD) as assessed by dose-limiting toxicity within 1 month after completion of study treatment (phase I)
Study Overview
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 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.
Detailed Description
OBJECTIVES:
- 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 continues in the absence of disease progression or unacceptable toxicity.
NOTE: *No prophylactic nodal radiotherapy is administered
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
radiotherapy + paclitaxel + carboplatin
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 continues in the absence of disease progression or unacceptable toxicity.
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.
Intervention: carboplatin (Drug)
radiotherapy + paclitaxel + carboplatin
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 continues in the absence of disease progression or unacceptable toxicity.
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.
Intervention: paclitaxel (Drug)
radiotherapy + paclitaxel + carboplatin
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 continues in the absence of disease progression or unacceptable toxicity.
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.
Intervention: radiation therapy (Radiation)
Outcomes
Primary Outcomes
Maximum tolerated dose (MTD) as assessed by dose-limiting toxicity within 1 month after completion of study treatment (phase I)
Time Frame: Up to 1 month
Survival at 2 years (phase II)
Time Frame: Up to 2 years
Secondary Outcomes
- Survival time(Up to 5 years)
- Toxicity(Up to 5 years)
- Time to progression(Up to 5 years)
- Time to local progression(Up to 5 years)