Status:
COMPLETED
Concurrent Once Daily Versus Twice Daily Radiotherapy for Limited Stage Small Cell Lung Cancer
Lead Sponsor:
The Christie NHS Foundation Trust
Collaborating Sponsors:
Cancer Research UK
NCIC Clinical Trials Group
Conditions:
Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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. Radiati...
Detailed Description
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 radiother...
Eligibility Criteria
Inclusion
- 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
- FEV1 \>1 litre or 40% predicted value
- KCO (DLCO/VA) \>40%predicted
- Maximum of one of the following adverse biochemical factors:
- Serum alkaline phosphatase more than \>1.5 times the upper limit of normal (ULN)
- Serum sodium \< Lower limit of Normal
- 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
- Neutrophils \>1.5 x 109/l
- 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
Exclusion
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2019
Estimated Enrollment :
547 Patients enrolled
Trial Details
Trial ID
NCT00433563
Start Date
April 1 2008
End Date
January 1 2019
Last Update
September 8 2022
Active Locations (1)
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1
The Christie NHS Foundation Trust
Manchester, United Kingdom, M20 4BX