Contact information
Type
Scientific
Primary contact
Ms Sally Falk
ORCID ID
Contact details
The Christie NHS Foundation Trust
Wilmslow Road
Manchester
M20 4BX
United Kingdom
-
sally.falk@christie.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00433563
Protocol/serial number
06-DOG07-68
Study information
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
Acronym
CONVERT
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.
Ethics approval
UK ethics approval on 21/12/2007
Study design
Multicentre randomised active-controlled parallel-group unblinded phase III trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
http://www.christie.nhs.uk/media/209035/Patient_info.pdf
Condition
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
Phase
Phase III
Drug names
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 trial start date
15/12/2005
Overall trial end date
15/02/2019
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
532
Participant exclusion criteria
Does not comply with the above inclusion criteria.
Recruitment start date
07/04/2008
Recruitment end date
29/11/2013
Locations
Countries of recruitment
Belgium, Canada, France, Netherlands, Poland, Slovenia, Spain, United Kingdom
Trial participating centre
The Christie NHS Foundation Trust
Manchester
M20 4BX
United Kingdom
Sponsor information
Organisation
The Christie NHS Foundation Trust (UK)
Sponsor details
Wilmslow Road
Manchester
M20 4BX
United Kingdom
-
sally.falk@christie.nhs.uk
Sponsor type
Government
Website
Funders
Funder type
Charity
Funder name
Cancer Research UK (UK) - Clinical Trials Advisory and Awards Committee (CTAAC) (ref: C17052/A8154)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2016 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/26792218