A 2-Arm Randomized Controlled Trial of Concurrent Chemo-Radiotherapy Comparing Twice-Daily and Once-Daily Radiotherapy Schedules in Patients With Limited Stage Small Cell Lung Cancer (SCLC) and Good Performance Status [CONVERT]
18 Years
N/A
Both
Lung Cancer
Trial Information
A 2-Arm Randomized Controlled Trial of Concurrent Chemo-Radiotherapy Comparing Twice-Daily and Once-Daily Radiotherapy Schedules in Patients With Limited Stage Small Cell Lung Cancer (SCLC) and Good Performance Status [CONVERT]
OBJECTIVES:
Primary
- Compare overall survival of patients with limited stage small cell lung cancer treated
with chemoradiotherapy comprising cisplatin, etoposide, and once vs twice daily
radiotherapy.
Secondary
- Compare local progression-free survival of patients treated with these regimens.
- Compare metastasis-free survival of patients treated with these regimens.
- Compare the toxicity of these regimens in these patients.
- Compare response rates in patients treated with these regimens.
- Compare the cytotoxic dose intensity of these regimens in these patients.
- Compare the dose intensity of two different schedules of radiotherapy in these
patients.
OUTLINE: This is a multicenter, randomized, controlled study. Patients are stratified
according to participating center, ECOG performance status (0-1 vs 2), and lactic
dehydrogenase, sodium, and alkaline phosphatase levels. Patients are randomized to 1 of 2
treatment arms.
- Arm I: Patients receive cisplatin IV over 2 hours on days 1-3 OR on day 1 only and
etoposide IV over 45-90 minutes on days 1-3. Treatment repeats every 21 days for up to
6 courses. During course 2, patients undergo concurrent radiotherapy once daily 5 days
a week for 6½ weeks (total of 33 fractions).
- Arm II: Patients receive cisplatin and etoposide as in arm I. During courses 2 and 3,
patients undergo concurrent radiotherapy twice daily 5 days a week for 3 weeks (total
of 30 fractions).
In both arms, treatment continues in the absence of disease progression or unacceptable
toxicity.
Beginning 3-4 weeks after completion of chemoradiotherapy, patients in both arms achieving a
complete or partial response with no evidence of brain metastasis undergo prophylactic
cranial irradiation once daily 5 days a week for 2 weeks (total of 10 fractions).
After completion of study treatment, patients are followed every 3 months for 1 year, every
6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 532 patients will be accrued for this study.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed small cell lung cancer
- Limited stage disease that can be encompassed within a radical radiation portal
- No mixed small cell or non-small cell histologic features
- No more than 1 of the following adverse factors:
- Alkaline phosphatase > 1.5 times upper limit of normal
- Sodium < lower limit of normal
- No malignant pleural or pericardial effusions
PATIENT CHARACTERISTICS:
- ECOG performance status 0-1
- Absolute neutrophil count > 1,500/mm³
- Platelet count > 100,000/mm³
- Creatinine normal
- Creatinine clearance ≥ 50 mL/min
- FEV_1 > 1 L OR > 40% of predicted
- DLCO > 40% of predicted
- No other medical condition that would preclude study treatment
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
- No prior surgical resection of the primary tumor
- No prior radiotherapy for lung cancer
- No other prior or concurrent therapy that would preclude study treatment
- No concurrent epoetin alfa for anemia
- No concurrent sargramostim (GM-CSF)
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Overall survival
Outcome Time Frame:
August 2015
Safety Issue:
No
Principal Investigator
Corinne Faivre-Finn, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Christie Hospital NHS Foundation Trust
Authority:
United Kingdom: Research Ethics Committee
Study ID:
CDR0000531709
NCT ID:
NCT00433563
Start Date:
April 2008
Completion Date:
August 2015
Related Keywords:
- Lung Cancer
- limited stage small cell lung cancer
- Lung Neoplasms
- Small Cell Lung Carcinoma
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