Lung CancerCONVERTNCT00433563
Concurrent Once Daily Versus Twice Daily Radiotherapy for Limited Stage Small Cell Lung Cancer
A study testing Once daily radiotherapy and Twice daily radiotherapy in people with Lung Cancer, run by The Christie NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Once daily radiotherapy and Twice daily radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 547 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2008to Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 27Show fewer
- 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
- 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
- Neutrophils >1.5 x 109/l
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
The Christie NHS Foundation Trust
Manchester, M20 4BX
About this study
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]
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.
Read the 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.
- Conditions
- Lung Cancer
- Being tested
- Once daily radiotherapy, Twice daily radiotherapy
- Keywords
- limited stage small cell lung cancer
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Once daily radiotherapyRadiation
Standard of care chemotherapy (cisplatin/etoposide) + once daily radiotherapy
Twice daily radiotherapyRadiation
Standard of care chemotherapy (cisplatin/etoposide) + twice daily radiotherapy
| Study group | Role | What they receive |
|---|---|---|
| Once daily radiotherapy | Experimental | Once daily radiotherapy Receives: Radiation: Once daily radiotherapy; Radiation: Twice daily radiotherapy |
| Twice daily radiotherapy | Active comparator | Twice daily radiotherapy Receives: Radiation: Once daily radiotherapy; Radiation: Twice daily radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Measured: August 2015
Secondary outcomes (5)
Local progression-free survival
Measured: August 2015
Metastasis-free survival
Measured: August 2015
Toxicity of treatment
Measured: August 2015
Cytotoxic dose intensity
Measured: August 2015
Radiotherapy dose intensity
Measured: August 2015
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2007 (estimated)
- Study startApr 2008
- Primary completionFeb 2016
- Study completionJan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 547 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Christie NHS Foundation Trust
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Sponsor
- Investigators
- Corinne Faivre-Finn, MD, Study chair, The Christie NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00433563
- Sponsor's protocol ID
- CDR0000531709
- Other IDs
- CHNT-CONVERT, CHNT-CTAAC-CONVERT-C17052/A815
- Acronym
- CONVERT
- Status last verified
- Sep 2022
- First submitted
- 8 Feb 2007
- Last updated
- 8 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Walls GM, Mistry H, Barlesi F, Bezjak A, Pechoux CL, O'Brien M, Van Meerbeeck JP, Blackhall F, Faivre-Finn C. Long-Term Outcomes After Concurrent Once- or Twice-Daily Chemoradiation in Limited-Stage Small Cell Lung Cancer: A Brief Report From the CONVERT Trial. Int J Radiat Oncol Biol Phys. 2024 Aug 1;119(5):1386-1390. doi: 10.1016/j.ijrobp.2024.02.063. Epub 2024 Mar 21.
PubMed 38521132Tay 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.
PubMed 31020334Salem 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.
PubMed 30520977Faivre-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.
PubMed 28642008Groom 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.
PubMed 28362511Colaco 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.
PubMed 22014897Sheikh 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.
PubMed 21353720
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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]
- ClinicalTrials.gov ID
- NCT00433563
- Acronym / sponsor ID
- CONVERT / CDR0000531709
- Conditions
- Lung Cancer
- Keywords
- limited stage small cell lung cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 547 participants (actual)
- Lead sponsor
- The Christie NHS Foundation TrustUniversity, hospital or other
- 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
- Study start
- Apr 2008
- Primary completion
- Feb 2016 (actual)
- Study completion
- Jan 2019 (actual)
- First posted
- 12 Feb 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Once daily radiotherapy | Experimental | Radiation: Once daily radiotherapy, Radiation: Twice daily radiotherapyOnce daily radiotherapy |
| Twice daily radiotherapy | Active comparator | Radiation: Once daily radiotherapy, Radiation: Twice daily radiotherapyTwice daily radiotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (27 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Once daily radiotherapyStandard of care chemotherapy (cisplatin/etoposide) + once daily radiotherapy | Radiation | Once daily radiotherapy, Twice daily radiotherapy |
| Twice daily radiotherapyStandard of care chemotherapy (cisplatin/etoposide) + twice daily radiotherapy | Radiation | Once daily radiotherapy, Twice daily radiotherapy |
Primary outcome
Overall survival
Time frame: August 2015
5 secondary outcomes
Local progression-free survival
Time frame: August 2015
Metastasis-free survival
Time frame: August 2015
Toxicity of treatment
Time frame: August 2015
Cytotoxic dose intensity
Time frame: August 2015
Radiotherapy dose intensity
Time frame: August 2015
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2022.
- Derived from this study: PubMed 38521132Walls GM, Mistry H, Barlesi F, Bezjak A, Pechoux CL, O'Brien M, Van Meerbeeck JP, Blackhall F, Faivre-Finn C. Long-Term Outcomes After Concurrent Once- or Twice-Daily Chemoradiation in Limited-Stage Small Cell Lung Cancer: A Brief Report From the CONVERT Trial. Int J Radiat Oncol Biol Phys. 2024 Aug 1;119(5):1386-1390. doi: 10.1016/j.ijrobp.2024.02.063. Epub 2024 Mar 21.
- Derived from this study: PubMed 31020334Tay 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.
- Derived from this study: PubMed 30520977Salem 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.
- Derived from this study: PubMed 28642008Faivre-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.
- Derived from this study: PubMed 28362511Groom 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.
- Derived from this study: PubMed 22014897Colaco 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.
- Derived from this study: PubMed 21353720Sheikh 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Corinne Faivre-Finn, MD study chair
The Christie NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Once daily radiotherapy and Twice daily radiotherapy in people with Lung Cancer, run by The Christie NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 27 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: August 2015). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00433563, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2022.