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Clinical Trials/ISRCTN91927162
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

Registry
who.int
Start Date
October 8, 2007
End Date
February 15, 2019
Last Updated
4 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Christie Hospital NHS Foundation Trust

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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