Concurrent Once Daily Versus Twice Daily Radiotherapy for Limited Stage Small Cell Lung Cancer | Not Recruiting
Concurrent Once Daily Versus Twice Daily Radiotherapy for Limited Stage Small Cell Lung Cancer
CONVERT
Trial Source

Health Conditions
  • Lung Cancer
Not Recruiting
Recruitment Status
NCT00433563
Primary Trial ID Number
Summary
RATIONALE: Drugs used in chemotherapy, such as cisplatin and etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet known which schedule of radiation therapy is more effective when given together with chemotherapy in treating small cell lung cancer. PURPOSE: This randomized phase III trial is studying two different schedules of radiation therapy to compare how well they work when given together with cisplatin and etoposide in treating patients with limited stage small cell lung cancer.
Primary Outcome Measures
  • Overall survival; August 2015
Secondary Outcome Measures
  • Local progression-free survival; August 2015; Metastasis-free survival; August 2015; Toxicity; August 2015; Cytotoxic dose intensity; August 2015; Radiotherapy dose intensity; August 2015
Research Question
  • RATIONALE: Drugs used in chemotherapy, such as cisplatin and etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet known which schedule of radiation therapy is more effective when given together with chemotherapy in treating small cell lung cancer. PURPOSE: This randomized phase III trial is studying two different schedules of radiation therapy to compare how well they work when given together with cisplatin and etoposide in treating patients with limited stage small cell lung cancer.
Design Type
Sorry, this information is not available
Ethics Approval
Sorry, this information is not available
Publications
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Countries of Recruitment
United Kingdom
Participant Sex
Both
Participant Age Range
18 Years to N/A
Participant Type
Sorry, this information is not available
Trial Sample Size
Sorry, this information is not available
Participant Inclusion Criteria
  • Inclusion/exclusion 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) 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
  • - Pulmonary function
  • 1. FEV1 >1 litre or 40% predicted value
  • 2. KCO (DLCO/VA) >40%predicted
  • - Maximum of one of the following adverse biochemical factors:
  • 1. Serum alkaline phosphatase more than >1.5 times the upper limit of normal (ULN)
  • 2. Serum sodium < Lower limit of Normal
  • 3. 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
  • 1. Neutrophils >1.5 x 109/l
  • 2. Platelets >100 x 109/l
  • - Adequate liver function: ALT & AST <= 2.5 x ULN
  • - 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
Participant Exclusion Criteria
  • Inclusion/exclusion 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) 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
  • - Pulmonary function
  • 1. FEV1 >1 litre or 40% predicted value
  • 2. KCO (DLCO/VA) >40%predicted
  • - Maximum of one of the following adverse biochemical factors:
  • 1. Serum alkaline phosphatase more than >1.5 times the upper limit of normal (ULN)
  • 2. Serum sodium < Lower limit of Normal
  • 3. 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
  • 1. Neutrophils >1.5 x 109/l
  • 2. Platelets >100 x 109/l
  • - Adequate liver function: ALT & AST <= 2.5 x ULN
  • - 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
Interventions
Radiation; Once daily radiotherapy; Standard of care chemotherapy (cisplatin/etoposide) + once daily radiotherapy; [Once daily radiotherapy, Twice daily radiotherapy]; Radiation; Twice daily radiotherapy; Standard of care chemotherapy (cisplatin/etoposide) + twice daily radiotherapy; [Once daily radiotherapy, Twice daily radiotherapy]
Design Details
Sorry, this information is not available
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Results Reporting
Sorry, this information is not available
Acronym
CONVERT
Scientific Title
A 2-Arm Randomized 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]
Secondary Trial Identifying Number
CHNT-CONVERT; CHNT-CTAAC-CONVERT-C17052/A815
Website
http://cancer.gov/clinicaltrials/CHNT-CONVERT; http://www.christie.nhs.uk/research/themes/convert/
Study Funded By
Sally Falk
Funder Type
Sorry, this information is not available
Study Sponsored By
Sally Falk
Study Also Sponsored By
Cancer Research UK; NCIC Clinical Trials Group; European Organisation for Research and Treatment of Cancer - EORTC; Spanish Lung Cancer Group; Groupe Francais De Pneumo-Cancerologie; Intergroupe Francophone de Cancerologie Thoracique
Primary Sponsor Type
Sorry, this information is not available
Secondary Sponsor Type
Sorry, this information is not available
Key Dates

Date of First Enrollment
Date Not Available
Recruitment End Date
Date Not Available
Trial End Date
Date Not Available
Date added to Registry

08 Feb 2007

Last Updated

16 Apr 2014

Date Record Refreshed on UKCTG

31 Jul 2015