NCT00433563

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
547

participants targeted

Target at P75+ for not_applicable lung-cancer

Timeline
Completed

Started Apr 2008

Longer than P75 for not_applicable lung-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 8, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 12, 2007

Completed
1.1 years until next milestone

Study Start

First participant enrolled

April 1, 2008

Completed
7.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
2.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

September 8, 2022

Status Verified

September 1, 2022

Enrollment Period

7.8 years

First QC Date

February 8, 2007

Last Update Submit

September 5, 2022

Conditions

Lung Cancer

Keywords

limited stage small cell lung cancer

Outcome Measures

Primary Outcomes (1)

  • Overall survival

    August 2015

Secondary Outcomes (5)

  • Local progression-free survival

    August 2015

  • Metastasis-free survival

    August 2015

  • Toxicity of treatment

    August 2015

  • Cytotoxic dose intensity

    August 2015

  • Radiotherapy dose intensity

    August 2015

Study Arms (2)

Once daily radiotherapy

EXPERIMENTAL

Once daily radiotherapy

Radiation: Once daily radiotherapyRadiation: Twice daily radiotherapy

Twice daily radiotherapy

ACTIVE COMPARATOR

Twice daily radiotherapy

Radiation: Once daily radiotherapyRadiation: Twice daily radiotherapy

Interventions

Once daily radiotherapyRADIATION

Standard of care chemotherapy (cisplatin/etoposide) + once daily radiotherapy

Once daily radiotherapyTwice daily radiotherapy
Twice daily radiotherapyRADIATION

Standard of care chemotherapy (cisplatin/etoposide) + twice daily radiotherapy

Once daily radiotherapyTwice daily radiotherapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • 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
  • FEV1 \>1 litre or 40% predicted value
  • KCO (DLCO/VA) \>40%predicted
  • Maximum of one of the following adverse biochemical factors:
  • Serum alkaline phosphatase more than \>1.5 times the upper limit of normal (ULN)
  • Serum sodium \< Lower limit of Normal
  • Serum LDH \> ULN
  • +12 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Christie NHS Foundation Trust

Manchester, M20 4BX, United Kingdom

Location

Related Publications (6)

  • Tay RY, Fernandez-Gutierrez F, Foy V, Burns K, Pierce J, Morris K, Priest L, Tugwood J, Ashcroft L, Lindsay CR, Faivre-Finn C, Dive C, Blackhall F. Prognostic value of circulating tumour cells in limited-stage small-cell lung cancer: analysis of the concurrent once-daily versus twice-daily radiotherapy (CONVERT) randomised controlled trial. Ann Oncol. 2019 Jul 1;30(7):1114-1120. doi: 10.1093/annonc/mdz122.

    PMID: 31020334DERIVED

  • Salem A, Mistry H, Hatton M, Locke I, Monnet I, Blackhall F, Faivre-Finn C. Association of Chemoradiotherapy With Outcomes Among Patients With Stage I to II vs Stage III Small Cell Lung Cancer: Secondary Analysis of a Randomized Clinical Trial. JAMA Oncol. 2019 Mar 1;5(3):e185335. doi: 10.1001/jamaoncol.2018.5335. Epub 2019 Mar 14.

    PMID: 30520977DERIVED

  • Faivre-Finn C, Snee M, Ashcroft L, Appel W, Barlesi F, Bhatnagar A, Bezjak A, Cardenal F, Fournel P, Harden S, Le Pechoux C, McMenemin R, Mohammed N, O'Brien M, Pantarotto J, Surmont V, Van Meerbeeck JP, Woll PJ, Lorigan P, Blackhall F; CONVERT Study Team. Concurrent once-daily versus twice-daily chemoradiotherapy in patients with limited-stage small-cell lung cancer (CONVERT): an open-label, phase 3, randomised, superiority trial. Lancet Oncol. 2017 Aug;18(8):1116-1125. doi: 10.1016/S1470-2045(17)30318-2. Epub 2017 Jun 20.

    PMID: 28642008DERIVED

  • Groom N, Wilson E, Faivre-Finn C. Effect of accurate heart delineation on cardiac dose during the CONVERT trial. Br J Radiol. 2017 May;90(1073):20170036. doi: 10.1259/bjr.20170036. Epub 2017 Mar 31.

    PMID: 28362511DERIVED

  • Colaco R, Sheikh H, Lorigan P, Blackhall F, Hulse P, Califano R, Ashcroft L, Taylor P, Thatcher N, Faivre-Finn C. Omitting elective nodal irradiation during thoracic irradiation in limited-stage small cell lung cancer--evidence from a phase II trial. Lung Cancer. 2012 Apr;76(1):72-7. doi: 10.1016/j.lungcan.2011.09.015. Epub 2011 Oct 19.

    PMID: 22014897DERIVED

  • Sheikh H, Colaco R, Lorigan P, Blackhall F, Califano R, Ashcroft L, Taylor P, Thatcher N, Faivre-Finn C. Use of G-CSF during concurrent chemotherapy and thoracic radiotherapy in patients with limited-stage small-cell lung cancer safety data from a phase II trial. Lung Cancer. 2011 Oct;74(1):75-9. doi: 10.1016/j.lungcan.2011.01.020. Epub 2011 Feb 26.

    PMID: 21353720DERIVED

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Corinne Faivre-Finn, MD

    The Christie NHS Foundation Trust

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 8, 2007

First Posted

February 12, 2007

Study Start

April 1, 2008

Primary Completion

February 1, 2016

Study Completion

January 1, 2019

Last Updated

September 8, 2022

Record last verified: 2022-09

Locations

GB(1)