A trial comparing conventional fractionation with 'CHART' in the treatment of head and neck cancer
| ISRCTN | ISRCTN68133429 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN68133429 |
| Protocol serial number | CH02 |
| Sponsor | Medical Research Council (MRC) (UK) |
| Funder | Medical Research Council (MRC) (UK) |
- Submission date
- 28/02/2001
- Registration date
- 28/02/2001
- Last edited
- 29/10/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr James Lyddiard
Scientific
Scientific
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom
| abc@email.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | A trial comparing conventional fractionation with 'CHART' in the treatment of head and neck cancer |
| Study objectives | To compare the effectiveness of radical fractionated radiotherapy given daily over 6 weeks with CHART over 12 days, with respect to local tumour control, survival and morbidity |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Cancer |
| Intervention | Conventional radiotherapy arm - 2 Gy, once daily five days a week over six weeks (large volume - 44 Gy in 22 fractions followed by small volume - 16 Gy in eight fractions) CHART arm - 1.5 Gy, three time daily over 12 treatment days (large volume - 37.5 Gy in 25 fractions followed by small volume - 16.5 Gy in 11 fractions) |
| Intervention type | Other |
| Primary outcome measure(s) |
1. Local tumour control |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/03/1995 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 500 |
| Key inclusion criteria | 1. Histologically proven squamous cell carcinoma of all grades at one of the following sites: Nasal sinuses, Nasopharynx, Oral cavity, Oropharynx, Hypopharynx, Carcinoma of the larynx 2. A radical course of external beam radiotherapy is the appropriate sole treatment |
| Key exclusion criteria | There should be no evidence of distant metastases beyond the regional nodes in the neck |
| Date of first enrolment | 01/01/1990 |
| Date of final enrolment | 01/03/1995 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom
NW1 2DA
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
29/10/2019: No publications found. All search options exhausted.
