Status:
COMPLETED
Induction Chemotherapy for Advanced Head and Neck Cancer
Lead Sponsor:
Barretos Cancer Hospital
Conditions:
Head and Neck Cancer
Eligibility:
All Genders
18-76 years
Phase:
PHASE2
Brief Summary
Over the last 30 years, induction chemotherapy (IC) has become important for the management of patients with locally advanced HNSCC (LAHNSCC), particularly since the introduction of taxanes. The resul...
Detailed Description
This non-randomized phase II trial evaluated the safety, feasibility and response rates of concurrent therapy (cisplatin and radiotherapy) after three cycles of an IC regimen based on the combination ...
Eligibility Criteria
Inclusion
- Histologically confirmed locally advanced squamous cell carcinoma of head and neck (stage III and IV) eligible to chemoradiotherapy.
- Presence of measurable disease
- ≥ 18 year
- ECOG performance status: 0-2
- Adequate bone marrow functions evidenced by: absolute neutrophil count ≥ 1.5 x 109/L; platelet count ≥ 100 x 109/L and hemoglobin ≥ 90 g/L
- Adequate renal function.
- Adequate hepatic function.
- Patients or their legal representatives must be able to read, understand and provide written informed consent to participate in the study.
Exclusion
- Any previous chemotherapy or radiotherapy
- Patients who have known hypersensitivity to paclitaxel or cisplatin
- Patients who are receiving concurrent investigational, biological or immune therapies
- Concomitant administration of high doses of systemic corticosteroids
- Known HIV or Hepatitis B or C (active, previously treated or both; testing is not required)
- Uncontrolled CNS disease (e.g., seizures not controlled with standard medical therapy)
- Clinically significant cardiovascular disease.
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2013
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00959387
Start Date
August 1 2009
End Date
April 1 2013
Last Update
March 26 2014
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Barretos Cancer Hospital
Barretos, São Paulo, Brazil, 14784-400