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 |
| Secondary identifying numbers | N0063116003 |
- 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
| Study design | Randomised/Prospective Pilot Phase I/II clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 | Primary end point: to assess tolerability of modestly accelerated radiotherapy with synchronous cisplatin chemotherapy |
| Secondary outcome measures | 1. Disease-free survival 2. Normal tissue toxicity |
| Overall study start date | 05/07/2002 |
| Completion date | 31/12/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 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
- England
- United Kingdom
Study participating centre
Clinical Oncology
Manchester
M20 4BX
United Kingdom
M20 4BX
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.dh.gov.uk/Home/fs/en |
|---|
Funders
Funder type
Government
Christie Hospital NHS Trust (UK)
No information available
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/03/2011 | Yes | No |
