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Sponsored by: |
Trans-Tasman Radiation Oncology Group (TROG) |
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Information provided by: | Trans-Tasman Radiation Oncology Group (TROG) |
ClinicalTrials.gov Identifier: | NCT00704639 |
This is a Phase II study of cetuximab, carboplatin and radiotherapy (RT) in patients with Locally Advanced Head and Neck Carcinomas (LAHNC) who are unfit for cisplatin. The aim of this study is to show the feasibility and safety profile of the combination of cetuximab, carboplatin and RT in treatment of patients with LAHNC.
Condition | Intervention | Phase |
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Head and Neck Cancer |
Drug: Cetuximab Drug: Carboplatin Radiation: Radiotherapy |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
Official Title: | A Phase II Study of Cetuximab, Carboplatin and Radiotherapy for Locally Advanced Head and Neck Squamous Cell Carcinoma |
Estimated Enrollment: | 60 |
Study Start Date: | April 2008 |
Estimated Study Completion Date: | June 2013 |
Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Chemoradiation
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Drug: Cetuximab
Patients will receive weekly intravenous cetuximab (initial dose 400mg/m2 in the week prior to commencing radiotherapy, then weekly 250mg/m2)for the duration of the radiotherapy
Drug: Carboplatin
Weekly intravenous carboplatin (AUC 2) for the duration of the RT
Radiation: Radiotherapy
The radiotherapy schedule will be the "infield boost" (IFB) regimen, that is 66 Gy in 35 fractions over 5 weeks: daily for 3 weeks, then twice daily for 2 weeks (or 70 Gy in 35 fractions over 7 weeks for a specific subgroup of patients where IFB is not recommended).
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Secondary objectives are to estimate failure free survival (FFS) and overall survival, to evaluate the time to local and regional failure and to determine the site of first failure (characterised as local, regional, distant or combinations). Acute and late treatment toxicities will also be evaluated.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients medically unfit for cisplatin chemotherapy due to one or more of the following reasons:
Adequate haematological, renal and hepatic functions as defined by:
Exclusion Criteria:
Patients with lesions < 5mm can be included if the investigator considers on clinical grounds that metastases are unlikely. Patients with multiple lung nodules should not be included unless there is a strong case that these do not represent metastases, e.g., stable on imaging for over 12 months, non-malignant aetiology apparent. The level of clinical suspicion may be influenced by clinical stage, e.g., N3 disease, low neck nodes. In general if there is any doubt patients should be excluded.
Contact: Teresa Morgan | +61 3 9656 5802 ext 5802 | Teresa.Morgan@petermac.org |
Contact: Danny Rischin | +61 3 9656 1804 | Danny.Rischin@petermac.org |
Australia, Victoria | |
Peter MacCallum Cancer Centre | Recruiting |
Melbourne, Victoria, Australia, 3002 | |
Contact: June Corry, MBBS,FRANZER 613 9656 1111 ext 1111 june.corry@petermac.org |
Study Chair: | June Corry | Peter MacCallum Cancer Centre, Australia |
Study Chair: | Danny Rischin | Peter MacCallum Cancer Centre, Australia |
Responsible Party: | Trans Tasman Radiation Oncology Group ( Associate Professor June Corry ) |
Study ID Numbers: | TROG 07.04 |
Study First Received: | June 22, 2008 |
Last Updated: | May 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00704639 History of Changes |
Health Authority: | Australia: Human Research Ethics Committee |
Head and Neck Cetuximab Carboplatin Radiotherapy |
Head and Neck Neoplasms Cetuximab Epidermoid Carcinoma Carboplatin |
Squamous Cell Carcinoma Carcinoma, Squamous Cell Carcinoma |
Neoplasms Neoplasms by Site Antineoplastic Agents Therapeutic Uses |
Head and Neck Neoplasms Cetuximab Carboplatin Pharmacologic Actions |