Concurrent Once Daily Versus Twice Daily Radiotherapy for Limited Stage Small Cell Lung Cancer (CONVERT)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
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
Information provided by (Responsible Party):
Sally Falk, Christie Hospital NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT00433563
First received: February 8, 2007
Last updated: April 16, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Lung Cancer
Radiation: Once daily radiotherapy
Radiation: Twice daily radiotherapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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]

Resource links provided by NLM:


Further study details as provided by Christie Hospital NHS Foundation Trust:

Primary Outcome Measures:
  • Overall survival [ Time Frame: August 2015 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Local progression-free survival [ Time Frame: August 2015 ] [ Designated as safety issue: No ]
  • Metastasis-free survival [ Time Frame: August 2015 ] [ Designated as safety issue: No ]
  • Toxicity [ Time Frame: August 2015 ] [ Designated as safety issue: Yes ]
  • Cytotoxic dose intensity [ Time Frame: August 2015 ] [ Designated as safety issue: Yes ]
  • Radiotherapy dose intensity [ Time Frame: August 2015 ] [ Designated as safety issue: No ]

Enrollment: 547
Study Start Date: April 2008
Estimated Study Completion Date: November 2015
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Once daily radiotherapy
Once daily radiotherapy
Radiation: Once daily radiotherapy
Standard of care chemotherapy (cisplatin/etoposide) + once daily radiotherapy
Radiation: Twice daily radiotherapy
Standard of care chemotherapy (cisplatin/etoposide) + twice daily radiotherapy
Active Comparator: Twice daily radiotherapy
Twice daily radiotherapy
Radiation: Once daily radiotherapy
Standard of care chemotherapy (cisplatin/etoposide) + once daily radiotherapy
Radiation: Twice daily radiotherapy
Standard of care chemotherapy (cisplatin/etoposide) + twice daily radiotherapy

Detailed Description:

OBJECTIVES:

Primary

  • Compare overall survival of patients with limited stage small cell lung cancer treated with chemoradiotherapy comprising cisplatin, etoposide, and once vs twice daily radiotherapy.

Secondary

  • Compare local progression-free survival of patients treated with these regimens.
  • Compare metastasis-free survival of patients treated with these regimens.
  • Compare the toxicity of these regimens in these patients.
  • Compare response rates in patients treated with these regimens.
  • Compare the cytotoxic dose intensity of these regimens in these patients.
  • Compare the dose intensity of two different schedules of radiotherapy in these patients.

OUTLINE: This is a multicenter, randomized, controlled study. Patients are stratified according to participating center, ECOG performance status (0-1 vs 2), and lactic dehydrogenase, sodium, and alkaline phosphatase levels. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive cisplatin IV over 2 hours on days 1-3 OR on day 1 only and etoposide IV over 45-90 minutes on days 1-3. Treatment repeats every 21 days for up to 6 courses. During course 2, patients undergo concurrent radiotherapy once daily 5 days a week for 6½ weeks (total of 33 fractions).
  • Arm II: Patients receive cisplatin and etoposide as in arm I. During courses 2 and 3, patients undergo concurrent radiotherapy twice daily 5 days a week for 3 weeks (total of 30 fractions).

In both arms, treatment continues in the absence of disease progression or unacceptable toxicity.

Beginning 3-4 weeks after completion of chemoradiotherapy, patients in both arms achieving a complete or partial response with no evidence of brain metastasis undergo prophylactic cranial irradiation once daily 5 days a week for 2 weeks (total of 10 fractions).

After completion of study treatment, patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 532 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00433563

Locations
United Kingdom
The Christie NHS Foundation Trust
Manchester, United Kingdom, M20 4BX
Sponsors and Collaborators
Sally Falk
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
Investigators
Study Chair: Corinne Faivre-Finn, MD Christie Hospital NHS Foundation Trust
  More Information

Additional Information:
No publications provided by Christie Hospital NHS Foundation Trust

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sally Falk, Dr Corinne Faivre-Finn, Christie Hospital NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT00433563     History of Changes
Other Study ID Numbers: CDR0000531709, CHNT-CONVERT, CHNT-CTAAC-CONVERT-C17052/A815
Study First Received: February 8, 2007
Last Updated: April 16, 2014
Health Authority: United Kingdom: Research Ethics Committee
Canada: Health Canada
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Committee for the Protection of Personnes
Spain: Ethics Committee

Keywords provided by Christie Hospital NHS Foundation Trust:
limited stage small cell lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms

ClinicalTrials.gov processed this record on September 14, 2014