CONVERT - 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.
CONVERT is a multicentre, international, phase III randomised controlled trial of concurrent chemoradiotherapy for limited stage small cell lung cancer. For further information please select the appropriate link below.
Information for healthcare professionals
Current status of the CONVERT trial
The CONVERT trial commenced patient recruitment in early April 2008, recruitment to the trial is expected to take around 4 years. CONVERT is still open to additional sites, for further information please contact Chief Investigator Dr Corinne Faivre-Finn or trial manager Helen Flight.
Protocol summary
- Type of design: This is a multicentre randomised phase III trial. Patients are randomised to one of two treatment arms with 1:1 randomisation: Patients will be randomly allocated to treatment by a minimisation procedure (with a random element) using a number of clinically important stratification factors.
- Patients studied: Histologically or cytologically confirmed SCLC with limited 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. ECOG performance status 0-2.
Trial interventions
- Control Arm:
- Four to six cycles of Cisplatin 25 mg/m2 iv D1-3 or 75 mg/m2 D1 Etoposide 100 mg/m2 iv D1-3.
- Concurrent BD radiotherapy 45Gy in 30 twice-daily fractions over 3 weeks, 5 days per week from day 22 of cycle 1
- Experimental Arm:
- Four to six cycles of Cisplatin 25 mg/m2 iv D1-3 or 75 mg/m2 D1 Etoposide 100 mg/m2 iv D1-3.
- Concurrent OD radiotherapy 66Gy in 33 daily fractions over 6.5 weeks, 5 days per week from day 22 of cycle 1
- Accrual:
- At least 532 patients are to be recruited over 4 years.
Outcome measures:
- Primary end-point
- Secondary end points
- Local progression-free survival
- Metastasis-free survival
- CTCAE v3.0 toxicity
- Chemotherapy dose intensity
- Radiotherapy dose intensity
- Duration of assessment:
Patients will be assessed prior to each cycle of chemotherapy and at 4 weeks after the final cycle. Follow-up will be at 3 monthly intervals for 12 months and six monthly thereafter until death. Post treatment CT scans thorax and abdomen will be done within 4 weeks of cycle 4 (even if 6 cycles are given) and 6 months after randomisation.
Eligibility 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) i.e. 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
- 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
Information for patients
The following documents contain information for patients about the CONVERT trial:
For general information about all aspects of cancer, including clinical trials, the following resources may be useful:
Information for investigators:
Investigators and other research staff who are working on the CONVERT trial, please click here to access trial documentation
Contacts for further information:
Chief Investigator: Dr Corinne Faivre-Finn
Clinical Trial Manager: Sally Falk
Further information
CONVERT is sponsored by The Christie NHS Foundation Trust, with funding from Cancer Research UK