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

ISRCTN	ISRCTN91927162
DOI	https://doi.org/10.1186/ISRCTN91927162
ClinicalTrials.gov number	NCT00433563
Secondary identifying numbers	06-DOG07-68

Submission date: 17/09/2007
Registration date: 08/10/2007
Last edited: 16/06/2021

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-study-to-find-the-best-way-to-give-radiotherapy-for-people-with-small-cell-lung-cancer

Study website

Contact information

Dr Helen Bradley
Scientific

Manchester Clinical Trials Unit
The University of Manchester
Room 1.316, Jean McFarlane Building
Oxford Road
Manchester
M13 9PL
United Kingdom

Phone	+44 0161 306 8239
Email	helen.bradley@manchester.ac.uk

Study information

Study design	Multicentre randomised active-controlled parallel-group unblinded phase III trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	http://www.christie.nhs.uk/media/209035/Patient_info.pdf
Scientific 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
Study acronym	CONVERT
Study objectives	This study aims to establish a standard chemo-therapy regimen for patients with limited stage Small Cell Lung Cancer (SCLC) and good performance status.
Ethics approval(s)	UK ethics approval on 21/12/2007
Health condition(s) or problem(s) studied	Limited stage small cell lung cancer
Intervention	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.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Phase III
Drug / device / biological / vaccine name(s)	Cisplatin, etoposide
Primary outcome measure	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 measures	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.
Overall study start date	15/12/2005
Completion date	15/02/2019

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	532
Total final enrolment	547
Key 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
Key exclusion criteria	Does not comply with the above inclusion criteria.
Date of first enrolment	07/04/2008
Date of final enrolment	29/11/2013

Locations

Countries of recruitment

Belgium
Canada
England
France
Netherlands
Poland
Slovenia
Spain
United Kingdom

Study participating centre

The Christie NHS Foundation Trust

Manchester
M20 4BX
United Kingdom

Sponsor information

Christie Hospital NHS Foundation Trust
Hospital/treatment centre

Wilmslow Road
Manchester
M20 4BX
England
United Kingdom

Email	the-christie.sponsoredresearch@nhs.net
Website	http://www.christie.nhs.uk/
"ROR"	https://ror.org/03v9efr22

Funders

Funder type

Charity

Cancer Research UK
Private sector organisation / Other non-profit organizations

Alternative name(s): CR_UK, Cancer Research UK - London, CRUK
Location: United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Peer reviewed?	Patient-facing?
Plain English results			No	Yes
Protocol article	protocol	20/01/2016	Yes	No
Results article	sub-study results	01/05/2017	Yes	No
Results article	results	01/08/2017	Yes	No
Results article	secondary results	01/03/2019	Yes	No

Editorial Notes

16/06/2021: The following changes have been made:
1. The scientific contact has been updated.
2. The sponsor contact has been updated.
01/04/2020: The following changes have been made:
1. The public contact email address has been updated.
2. The sponsor email address has been updated.
19/03/2020: The public contact has been updated.
25/04/2019: The following changes were made to the trial record:
1. Publication references added.
2. The total final enrolment was added.
3. Link to results added to the results (plain English) field.
15/12/2016: The overall trial dates have been updated from 01/04/2008 - 01/12/2015 to 15/12/2005 - 15/02/2019 and the recruitment dates have been updated from 01/04/2008 - 01/12/2015 to 07/04/2008 - 29/11/2013.
07/10/2016: Publication reference added.
21/05/2014: The following changes were made to the trial record:
1. United States of America was removed from the countries of recruitment.
2. The overall trial start date was changed from 01/01/2008 to 01/04/2008.
3. The overall trial end date was changed from 01/01/2012 to 01/12/2015.

09/04/2008: France, Spain, the Netherlands, Poland, Belgium, Slovenia and Canada were added to the countries of recruitment.