A randomised two arm trial of modestly accelerated radiotherapy with synchronous cisplatinum chemotherapy versus conventional radiotherapy with synchronous cisplatinum chemotherapy in the treatment of head and neck squamous cell carcinoma: a pilot study
| ISRCTN | ISRCTN86478952 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN86478952 |
| Protocol serial number | N0063116003 |
| Sponsor | Department of Health |
| Funder | Christie Hospital NHS Trust (UK) |
- Submission date
- 30/09/2004
- Registration date
- 30/09/2004
- Last edited
- 01/10/2012
- 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 N J Slevin
Scientific
Scientific
Clinical Oncology
Christie Hospital NHS Trust
Wilmslow Road
Withington
Manchester
M20 4BX
United Kingdom
| Phone | +44 (0)161 446 3418 |
|---|
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised/Prospective Pilot Phase I/II clinical trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | |
| Study objectives | To assess tolerability (absence of grade IV reactions) of synchronous chemotherapy and modestly accelerated radiotherapy. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Cancer: Head and neck |
| Intervention | Twelve eligible patients will receive accelerated radiotherapy (six fractions per week, over 5½ weeks to a total dose of 68 Gray). The extra fraction will be given on any day Monday to Friday (preferably Monday or Friday) and treatment will not normally be given at weekends. Cisplatinum chemotherapy will be given at a dose of 100 mg/m^2 on day one of chemotherapy and then again three weeks later. Acute and late radiation toxicities will be monitored using the Danish Head and Neck Cancer Study Group (DAHANCA) Acute and Late Morbidity Scoring Criteria. |
| Intervention type | Other |
| Primary outcome measure(s) |
Primary end point: to assess tolerability of modestly accelerated radiotherapy with synchronous cisplatin chemotherapy |
| Key secondary outcome measure(s) |
1. Disease-free survival |
| Completion date | 31/12/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 12 |
| Key inclusion criteria | Patients with histologically proven squamous cell carcinoma of the oropharynx hypopharynx larynx or oral cavity (not nasopharynx/sinuses) and fully meet the criteria will be approached for consent. The study requires 12 patients. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 05/07/2002 |
| Date of final enrolment | 31/12/2008 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Clinical Oncology
Manchester
M20 4BX
United Kingdom
M20 4BX
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/03/2011 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
