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Clinical Trials/NCT00066222
NCT00066222CompletedPhase 2

A Phase II Study Of Accelerated High Dose Thoracic Irradiation With Concurrent Chemotherapy For Patients With Limited Small Cell Lung Cancer

Radiation Therapy Oncology Group104 sites in 1 country72 target enrollmentStarted: June 2003Last updated:
Conditions
Interventions
Drugs

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

Experimental

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

Experimental

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

Experimental

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)

Investigators

Sponsor Class
Network
Responsible Party
Sponsor

Study Sites (104)

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