ISRCTN91927162
Completed
Phase 3
A two-arm randomised 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
Christie Hospital NHS Foundation Trust0 sites547 target enrollmentOctober 8, 2007
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Christie Hospital NHS Foundation Trust
- Enrollment
- 547
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
2018 secondary results in: https://www.ncbi.nlm.nih.gov/pubmed/30520977 2017 results in: https://www.ncbi.nlm.nih.gov/pubmed/28642008 2017 sub-study results in: https://www.ncbi.nlm.nih.gov/pubmed/28362511 2016 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/26792218
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Either sex, aged greater than or equal to 18 years
- •2\. Estern Cooperative Oncology Group (ECOG) Performance Status (PS) 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
- •3\. Histologically or cytologically confirmed SCLC
- •4\. No patients with mixed small\-cell and non\-small\-cell histologic features
- •5\. 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
- •6\. Limited stage disease (Veterans Administration Lung Cancer Study Group), i.e., patients whose disease can be encompassed within a radical radiation portal
- •7\. No pleural or pericardial effusions proven to be malignant
- •8\. Radiotherapy (RT) target volume acceptable by the local radiotherapist
- •9\. Pulmonary function:
- •9\.1\. Forced Expiratory Volume in one second (FEV1\) greater than 1 litre or 40% predicted value
Exclusion Criteria
- •Does not comply with the above inclusion criteria.
Outcomes
Primary Outcomes
Not specified
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