Concurrent ONce-daily VErsus twice-daily RadioTherapy: A 2-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

• Conditions: lung cancer; 10029107; 10038666; oat cell carcinoma; small cell lung cancer

• Registration Number: NL-OMON33659
• Lead Sponsor: EORTC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 60

Inclusion Criteria

a)either sex, age *18 years
b) Performance status ECOG grade 0-1 (appendix 1).
c) Histologically or cytologically confirmed SCLC
d) No patients with mixed small-cell and non-small-cell histologic features
e) 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.
f) Limited stage disease (Veterans Administration Lung Cancer Study Group) ie patients whose disease can be encompassed within a radical radiation portal.
g) No pleural or pericardial effusions proven to be malignant
h) RT target volume acceptable by the local radiotherapist
i) Pulmonary function
a. FEV1 >1 litre or 40% predicted value
b. KCO (DLCO/VA) >40%predicted
j) Maximum of one of the following adverse biochemical factors:
a. Serum alkaline phosphatase more than >1.5 times the upper limit of normal (ULN)
b. Serum sodium < Lower limit of Normal
c. Serum LDH > UNL
k) 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 (appendix 5), an EDTA
clearance should be performed
l) Adequate haematological function
a. Neutrophils >1.5 x 109/l
b. Platelets >100 x 109/l
r) Patient has read the patient information sheet and has signed the consent form.
s) Patients available for follow-up
o) Considered fit to receive any of the trial regimens

Exclusion Criteria

Other previous or concomitant illness or treatment which in the opinion of the clinician will
interfere with the trial treatments or comparisons
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 childbearing
potential, or are using adequate contraception. Men must also use adequate
contraception, as etoposide is clastogenic.
Patients who are breastfeeding
Patients who are not available for adequate follow-up

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoint: overall survival</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints;<br /><br>Local progression-free survival<br /><br>Metastases-free survival<br /><br>CTCAE v3.0 toxicity<br /><br>Chemotherapy dose intensity<br /><br>Radiotherapy dose intensity</p><br>