Condition category
Cancer
Date applied
17/09/2007
Date assigned
08/10/2007
Last edited
07/10/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 measures

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

01/04/2008

Overall trial end date

01/12/2015

Reason abandoned

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

01/04/2008

Recruitment end date

21/05/2014

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

http://www.christie.nhs.uk/

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

Results - basic reporting

Publication summary

2016 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/26792218

Publication citations

Additional files

Editorial Notes

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.