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| 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 |
| Source of record | UK Trials |
| ISRCTN | ISRCTN91927162 |
| Date ISRCTN assigned | 08/10/2007 |
| Local reference number(s) | 06-DOG07-68 |
| Public title | 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 |
| Scientific title | |
| Acronym | CONVERT |
| Disease/condition/study domain | Limited stage small cell lung cancer |
| Study hypothesis | This study aims to establish a standard chemo-therapy regimen for patients with limited stage Small Cell Lung Cancer (SCLC) and good performance status. Please note that as of 09/04/2008 this trial started recruiting patients, and the ethics approval, countries of recruitment and the inclusion criteria have been updated. Please look under the relevant field for more details of the amendments made. Please also note that France, Spain, the Netherlands, Poland, Belgium, Slovenia and Canada were added to the countries of recruitment at this time. |
| Design/methodology | Multicentre, randomised, active controlled, parallel group, unblinded, phase III trial. |
| Research ethics review | Added as of 09/04/2008: UK ethics approval was received on the 21st December 2007. |
| Countries of trial | United Kingdom, United States of America, France, Spain, the Netherlands, Poland, Belgium, Slovenia, Canada |
| Participants - 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 |
| Participants - exclusion criteria | Does not comply with the above inclusion criteria. |
| Patient information material | |
| Anticipated start date | 01/01/2008 |
| Anticipated end date | 01/01/2012 |
| Status of trial | Ongoing |
| Target number of participants | 532 |
| Interventions | Control arm: 1. Between 4 and 6 cycles of cisplatin and etoposide (cisplatin 25 mg/m^2 intravenous [iv] day 1 - 3 or 75 mg/m^2 day 1, etoposide 100 mg/m^2 iv day 1 - 3) 2. Concurrent twice daily (BD) radiotherapy 45 Gy, 30 twice-daily fractions over 3 weeks, 5 days per week from day 22 of cycle 1 3. Prophylactic Cranial Irradiation (PCI) will be given if indicated Experimental arm: 1. Between 4 and 6 cycles of cisplatin and etoposide (cisplatin 25 mg/m^2 iv day 1 - 3 or 75 mg/m^2 day 1, etoposide 100 mg/m^2 iv day 1 - 3) 2. Concurrent once daily (OD) radiotherapy 66 Gy in 33 daily fractions over 6.5 weeks, 5 days per week from day 22 of cycle 1 3. Prophylactic Cranial Irradiation (PCI) will be given if indicated Patients will undergo screening examinations and will then be randomised to a treatment arm. Treatment will begin within 2 weeks of randomisation. During chemoradiotherapy treatment the patient will be assessed prior to each cycle via physical exam and blood tests, with chest X-rays prior to cycles 1, 3 and 5. Research staff will monitor any toxicities and record treatment and toxicity details on a Case Report Form (CRF). The patient will be seen again within 4 weeks of the final cycle for assessment, response to treatment will be evaluated and prophylactic cranial irradiation given if indicated. The patient will then enter the follow-up phase of the study - during follow-up patients will be seen at 3 monthly intervals for 12 months, and six monthly thereafter until death. |
| Primary outcome measure(s) | Overall survival. 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. |
| Secondary outcome measure(s) | 1. Local progression-free survival 2. Metastasis-free survival 3. Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0) toxicity 4. Chemotherapy dose intensity 5. Radiotherapy dose intensity 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. |
| Trial website | http://www.converttrial.com |
| Sources of funding | Cancer Research UK (UK) - Clinical Trials Advisory and Awards Committee (CTAAC) (ref: C17052/A8154) |
| Sponsor name | Christie Hospital NHS Foundation Trust (UK) |
| Sponsor details | Wilmslow Road Manchester United Kingdom M20 4BX |
| Sponsor email | Helen.Flight@christie.nhs.uk |
| Sponsor website | http://www.christie.nhs.uk/ |
| Contact name | Mrs Helen Flight |
| Contact details | Christie Hospital NHS Foundation Trust Wilmslow Road Manchester United Kingdom M20 4BX |
| Contact email | Helen.Flight@christie.nhs.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN91927162 |
| Date last extracted from ISRCTN register | 17/04/2008 |
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