Concurrent Once Daily Versus Twice Daily Radiotherapy for Limited Stage Small Cell Lung Cancer

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.

Sex

All

Minimum age

18 Years

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 cancer
* 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

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