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Post-operative Concurrent Chemo-radiotherapy Versus Post-operative Radiotherapy for Cancer of the Head and Neck

NCT00193895 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 321

Last updated 2018-04-06

No results posted yet for this study

Summary

The primary objective of the trial is to determine, in patients who have undergone surgery with curative intent for high-risk CSCC of the head and neck, whether there is a difference in time to loco-regional relapse between patients treated with post-operative concurrent chemo-radiotherapy ,consisting of Carboplatin, and post-operative radiotherapy alone. The target sample size for the trial is 266 patients and will take 3-4 years to accrue, based on an anticipated accrual of 80 patients/year. A further 2 years follow up is required.

Conditions

Interventions

DRUG

Carboplatin

Carboplatin will commence with a dose calculated to target an AUC of 2.0. A maximum of 6 doses of weekly Carboplatin will be given. Carboplatin will be administered intravenously over 20-30 minutes prior to radiation therapy.

RADIATION

Radiotherapy

60 Gy OR 66Gy in 2Gy/fraction 5days/week

Sponsors & Collaborators

  • Princess Alexandra Hospital, Brisbane, Australia

    collaborator OTHER

  • The Royal Australian and New Zealand College of Radiologists

    collaborator OTHER

  • Trans Tasman Radiation Oncology Group

    lead OTHER

Principal Investigators

  • Sandro Porceddu · Princess Alexandra Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-04-30
Primary Completion
2016-03-31
Completion
2016-03-31

Countries

  • Australia
  • New Zealand

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00193895 on ClinicalTrials.gov