Condition category
Cancer
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
01/10/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr N J Slevin

ORCID ID

Contact details

Clinical Oncology
Christie Hospital NHS Trust
Wilmslow Road
Withington
Manchester
M20 4BX
United Kingdom
+44 (0)161 446 3418

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0063116003

Study information

Scientific title

Acronym

Study hypothesis

To assess tolerability (absence of grade IV reactions) of synchronous chemotherapy and modestly accelerated radiotherapy.

Ethics approval

Not provided at time of registration

Study design

Randomised/Prospective Pilot Phase I/II clinical trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Phase I/II

Drug names

Primary outcome measures

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 trial start date

05/07/2002

Overall trial end date

31/12/2008

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

12

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

05/07/2002

Recruitment end date

31/12/2008

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Clinical Oncology
Manchester
M20 4BX
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

Christie Hospital NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/20951012

Publication citations

  1. Results

    Jegannathen A, Mais K, Sykes A, Lee L, Yap B, Birzgalis A, Homer J, Ryder WD, Slevin N, Synchronous chemoradiotherapy in patients with locally advanced squamous cell carcinoma of the head and neck using capecitabine: a single-centre, open-label, single-group phase II study., Clin Oncol (R Coll Radiol), 2011, 23, 2, 149-158, doi: 10.1016/j.clon.2010.09.010.

Additional files

Editorial Notes