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

Phase 3

Completed

• Conditions: imited stage small cell lung cancer; Cancer; Lung cancer

• Registration Number: ISRCTN91927162
• Lead Sponsor: Christie Hospital NHS Foundation Trust

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

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-10-08
• Study Completion: 2019-02-15
• Last Update Posted: 28 June 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 547

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
9.2. Carbon Monoxide Transfer Coefficient (KCO) (Carbon Monoxide Diffusing capacity in the whole Lung per unit Alveolar Volume [DLCO/VA]) greater than 40% predicted
10. Maximum of one of the following adverse biochemical factors:
10.1. Serum alkaline phosphatase more than 1.5 times the Upper Limit of Normal (ULN)
10.2. Serum sodium less than lower limit of normal
10.3. Serum lactate dehydrogenase (LDH) greater than upper limit of normal (added 09/04/2008)
11. Normal serum creatinine and calculated creatinine clearance greater than or equal to 50 ml/min. If calculated creatinine clearance is less than 50 ml/mn according to the Cockroft and Gault formula, an Ethylenediaminetetraacetic Acid (EDTA) clearance should be performed
12. Adequate haematological function:
12.1. Neutrophils greater than 1.5 x 10^9/l
12.2. Platelets greater than 100 x 10^9/l
13. No other previous or concomitant illness or treatment which in the opinion of the clinician will interfere with the trial treatments or comparisons
14. No prior surgical resection of the primary tumour, no prior radiotherapy for lung cancer
15. Considered fit to receive any of the trial regimens
16. 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
17. Patients must not be breastfeeding
18. Patient has read the patient information sheet and has signed the consent form
19. Patients available for follow-up

Exclusion Criteria

Does not comply with the above inclusion criteria.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Overall survival.<br><br> Information for each of the primary and secondary objectives will be gained by assessing the patient prior to each cycle of chemotherapy, at a completion visit within 4 weeks of the final cycle, and then at follow-up visits which are 3 monthly for the first year, then six monthly thereafter until death.<br>

Secondary Outcome Measures

Name	Time	Method
<br> 1. Local progression-free survival<br> 2. Metastasis-free survival<br> 3. Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0) toxicity<br> 4. Chemotherapy dose intensity<br> 5. Radiotherapy dose intensity<br><br> Information for each of the primary and secondary objectives will be gained by assessing the patient prior to each cycle of chemotherapy, at a completion visit within 4 weeks of the final cycle, and then at follow-up visits which are 3 monthly for the first year, then six monthly thereafter until death.<br>