A Phase II Study Of Accelerated High Dose Thoracic Irradiation With Concurrent Chemotherapy For Patients With Limited Small Cell Lung Cancer
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 72
- Locations
- 104
- Primary Endpoint
- Overall Survival at 2 Years
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 more than one chemotherapy drug with radiation therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving cisplatin and etoposide together with radiation therapy works in treating patients with limited-stage small cell lung cancer.
Detailed Description
OBJECTIVES:
- Determine the response rate of patients with limited stage small cell lung cancer treated with cisplatin and etoposide combined with accelerated high-dose thoracic radiotherapy.
- Determine the progression-free and overall survival in patients treated with this regimen.
- Determine the qualitative and quantitative toxicity and reversibility of toxicity of this regimen in these patients.
OUTLINE: Patients undergo radiotherapy once daily 5 days a week for approximately 3 weeks and then twice daily 5 days a week for approximately 2 weeks (a total of 9 treatment days during the final 2-week treatment period). Beginning on the first day of radiotherapy, patients receive cisplatin IV over 2 hours and etoposide IV over 1 hour on day 1 and oral etoposide once daily on days 2 and 3. Chemotherapy repeats every 3 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 71 patients will be accrued for this study within 18 months.
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
Radiation Therapy + Chemotherapy
Accelerated high dose thoracic radiation therapy (RT) with concurrent cisplatin/etoposide chemotherapy, followed by 2 cycles of adjuvant cisplatin/etoposide chemotherapy
Intervention: Cisplatin (Drug)
Radiation Therapy + Chemotherapy
Accelerated high dose thoracic radiation therapy (RT) with concurrent cisplatin/etoposide chemotherapy, followed by 2 cycles of adjuvant cisplatin/etoposide chemotherapy
Intervention: Etoposide (Drug)
Radiation Therapy + Chemotherapy
Accelerated high dose thoracic radiation therapy (RT) with concurrent cisplatin/etoposide chemotherapy, followed by 2 cycles of adjuvant cisplatin/etoposide chemotherapy
Intervention: Radiation therapy (Radiation)
Outcomes
Primary Outcomes
Overall Survival at 2 Years
Time Frame: From registration to 2 years
Survival time is defined as time from study registration to the date of death from any cause and survival rates are estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact.
Secondary Outcomes
- Overall Survival (OS) and Progression-free Survival (PFS) at 1 Year(From registration to one year.)
- Tumor Response(From the start of treatment to 2 months following the completion of chemotherapy)
- Median Overall Survival Time and Progression-free Survival Time(From registration to 2 years)
- Number of Patients With Acute Treatment-related Grade 3 or 4 Esophagitis(From start of radiation therapy until 90 days following the start of radiation therapy)
- Frequency of Treatment-related Fatalities at 2 Years(From the start of treatment to 2 years)