Completion of documentation of late effects of treatment of patients in both arms of the CHART studies (for previous work, refer to MRC Headoffice)
| ISRCTN | ISRCTN77727725 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN77727725 |
| Secondary identifying numbers | G9615854/9005262 |
- Submission date
- 06/04/2000
- Registration date
- 06/04/2000
- Last edited
- 07/11/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Ann Barrett
Scientific
Scientific
Beatson Oncology Centre
Western Infirmary
Dumbarton Road
Glasgow
G11 6NT
United Kingdom
| none@example.com |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Scientific title | Completion of documentation of late effects of treatment of patients in both arms of the CHART studies (for previous work, refer to MRC Headoffice) |
| Study objectives | The CHART trials, the largest of their kind in Europe, have shown an improvement in survival of 10% at 2 years in patients with carcinoma of the bronchus treated with CHART, as compared with conventional radiotherapy. In the head and neck trial, the overall benefit in local tumour control does not reach statistical significance but this is reached in important sub-groups. There is however as reduction in morbidity in this trial giving a therapeutic benefit. To determine the true usefulness of a new radiotherapy schedule and to build on the improvements obtained the effect on therapeutic ratio must be defined over time. During the trial full data has now been gathered and analysed concerned with acute reactions and in the follow up late morbidity and from this data we have been able to make important contributions to radiobiological knowledge in humans particularly by a calculation of the repair half-times of normal tissue being about twice as long as previously known. Recent publications include: 1. Bentzen SM, Saunders MI and Dische S. Repair half-times estimated from observations of treatment-related morbidity after CHART or conventional radiotherapy in head and neck cancer. Radiother Oncol 1999; 53:219-226 2. Ataman OU, Bentzen SM, Saunders MI and Dische S. Failure specific prognostic factors after Continuous Hyperfractionated Accelerated Radiotherapy (CHART) or conventional radiotherapy in locally advanced non-small cell lung cancer: A competing risk analysis. Br J Cancer 2001; 85:1113-1118. 3. Bentzen SM, Saunders MI, Dische S and Bond S. Radiotherapy early morbidity in head and neck cancer:quantitative clinical radiobiology as deduced from the CHART trial. Radiother Oncol 2000; 60: 123-135 4. Wilson GD, Saunders MI, Dische S, Richman PI, Daly FM and Bentzen SM. BCL-2 expression in head and neck cancer: an enigmatic prognostic marker. Int J Radiation Oncol Biology Phys 2001; 49; 435-441. 5. Bentzen SM, Saunders MI and Dische S. From CHART to CHARTWELL in non-small cell lung cancer: clinical radiobiological modelling of the expected changes in outcome. Clin Onc (Royal College of Radiologists-in press) 6. Khalil AA, bentzen SM, Bernier J, Saunders MI, Horiot J-C, van den Bogaert W, Cummings PG and Dische S. Compliance to prescribed dose and overall treatment time in five randomised clinical trials of altered radiotherapy fractionation in head and neck cancer. Int J Radiation Oncol Biol Phys (submitted 2002). |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Cancer |
| Intervention | CHART/conventional radiotherapy |
| Intervention type | Other |
| Primary outcome measure | The documentation of late effects as specified in the original CHART studies |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/07/1998 |
| Completion date | 01/07/2000 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 49 patients (bronchus) + 379 (head & neck) |
| Key inclusion criteria | Locally advanced cancer of the bronchus and in the major head and neck sites |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/07/1998 |
| Date of final enrolment | 01/07/2000 |
Locations
Countries of recruitment
- Scotland
- United Kingdom
Study participating centre
Beatson Oncology Centre
Glasgow
G11 6NT
United Kingdom
G11 6NT
United Kingdom
Sponsor information
Medical Research Council (MRC) (UK)
Research council
Research council
20 Park Crescent
London
W1B 1AL
United Kingdom
| Phone | +44 (0)20 7636 5422 |
|---|---|
| clinical.trial@headoffice.mrc.ac.uk | |
| Website | http://www.mrc.ac.uk |
Funders
Funder type
Research council
Medical Research Council (UK)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- Medical Research Council (United Kingdom), UK Medical Research Council, MRC
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 01/12/1999 | Yes | No | ||
| Results article | 01/08/2001 | Yes | No | ||
| Results article | 19/10/2001 | Yes | No |
Editorial Notes
07/11/2022: Internal review.
