RATIONALE: Drugs used in chemotherapy, such as cisplatin and etoposide, work in different
ways to stop the growth of tumor cells, either by killing the cells or by stopping them from
dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet known
which schedule of radiation therapy is more effective when given together with chemotherapy
in treating small cell lung cancer.
PURPOSE: This randomized phase III trial is studying two different schedules of radiation
therapy to compare how well they work when given together with cisplatin and etoposide in
treating patients with limited stage small cell lung cancer.
- Compare overall survival of patients with limited stage small cell lung cancer treated
with chemoradiotherapy comprising cisplatin, etoposide, and once vs twice daily
- 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
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
- 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
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.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Radiation : Once daily radiotherapy, Radiation : Twice daily radiotherapy
Study Arm Groups : Once daily radiotherapy, Twice daily radiotherapy, Once daily radiotherapy, Twice daily radiotherapy
See Interventions above
- Overall survival; August 2015
- Local progression-free survival; August 2015; Metastasis-free survival; August 2015; Toxicity; August 2015; Cytotoxic dose intensity; August 2015; Radiotherapy dose intensity; August 2015
Sorry, this information is not available
This is available on the Clinicaltrials.gov
18 Years - N/A
Sorry, this information is not available
- Inclusion/exclusion criteria:
- - Either sex, age ≥18 years
- - Performance status ECOG grade 0-1. Patients with PS 2 whose general condition is
- explained by obstructive/bulky disease likely to improve after the first cycle of
- chemotherapy can be included at the discretion of the local investigator. Patients
- with PS 2 as a result of comorbid conditions will be excluded.
- - Histologically or cytologically confirmed SCLC
- - No patients with mixed small-cell and non-small-cell histologic features
- - No history of previous malignancy in the last 5 years (except non melanomatous skin
- or in-situ cervix carcinoma). Patients with previous malignancies (except breast
- cancer) and in remission for at least 5 years can be included.
- - Limited stage disease (Veterans Administration Lung Cancer Study Group) ie patients
- whose disease can be encompassed within a radical radiation portal.
- - No pleural or pericardial effusions proven to be malignant
- - RT target volume acceptable by the local radiotherapist
- - Pulmonary function
- 1. FEV1 >1 litre or 40% predicted value
- 2. KCO (DLCO/VA) >40%predicted
- - Maximum of one of the following adverse biochemical factors:
- 1. Serum alkaline phosphatase more than >1.5 times the upper limit of normal (ULN)
- 2. Serum sodium < Lower limit of Normal
- 3. Serum LDH > ULN
- - Normal serum creatinine and calculated creatinine clearance >50 ml/min. If calculated
- creatinine clearance is <50 ml/mn according to the Cockroft and Gault formula, an
- EDTA clearance should be performed
- - Adequate haematological function
- 1. Neutrophils >1.5 x 109/l
- 2. Platelets >100 x 109/l
- - Adequate liver function: ALT & AST <= 2.5 x ULN
- - No other previous or concomitant illness or treatment which in the opinion of the
- clinician will interfere with the trial treatments or comparisons
- - No prior surgical resection of the primary tumour, no prior radiotherapy for lung
- - Considered fit to receive any of the trial regimens
- - Female patients must satisfy the investigator that they are not pregnant, or are not
- of child-bearing potential, or are using adequate contraception. Men must also use
- adequate contraception, as etoposide is clastogenic.
- - Patients must not be breastfeeding
- - Patient has read the patient information sheet and has signed the consent form.
- - Patients available for follow-up
This is in the inclusion criteria above
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]
Not available for this trial
- Cancer Research UK
- NCIC Clinical Trials Group
- European Organisation for Research and Treatment of Cancer - EORTC
- Spanish Lung Cancer Group
- Groupe Francais De Pneumo-Cancerologie
- Intergroupe Francophone de Cancerologie Thoracique