Head and Neck Cancer Clinical Trial
Official title:
Induction Chemotherapy (IC) With Paclitaxel and Cisplatin (PC) Followed by Concomitant Chemoradiotherapy (CCRT) in Patient With Advanced Squamous Carcinoma of the Head and Neck (SSCHN).
Verified date | March 2014 |
Source | Barretos Cancer Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | Brazil: Ethics Committee |
Study type | Interventional |
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 results reported in the TAX 323 and TAX 324 trials indicate that the TPF
regimen (docetaxel, cisplatin and 5-fluorouracil) improves overall survival comparing with
the PF regimen (cisplatin and 5-fluorouracil), and the TPF regimen is globally the most
accepted induction regimen for the treatment of LAHNSCC.
However, the TPF regimen has been associated with high toxicity rates, and patients
frequently decline cisplatin during concurrent radiotherapy and require the use of infusion
pumps and a central venous catheter.
Extensive efforts are ongoing to identify alternative schemes that are less toxic than the
TPF regimen but are as effective for LAHNSCC and safely allow the use of definitive
concurrent treatment based on cisplatin and radiotherapy.
Status | Completed |
Enrollment | 60 |
Est. completion date | April 2013 |
Est. primary completion date | November 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 76 Years |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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. |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Brazil | Barretos Cancer Hospital | Barretos | São Paulo |
Lead Sponsor | Collaborator |
---|---|
Barretos Cancer Hospital |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Tumor response rate | Tumor response was assessed after induction chemotherapy (just before chemoradiotherapy) and 6-8 weeks after completion of chemoradiotherapy. Evaluation of tumor response was by clinical examination, nasoendoscopy, and CT or MRI imaging of the primary site and the neck (RECIST criteria 1.1). |
At baseline, 2 weeks after the third cycle of IC and 6-8 weeks after the end of radiotherapy | Yes |
Secondary | Overall survival | Overall survival (OS) was calculated as the time of study entry to the date of death. | 3 years | Yes |
Secondary | Quality of life (EORTC QLQ-C30) | Questionnaire of quality of life (EORTC QLQ-C30) was applied at baseline, before chemoradiotherapy and 60 days following last day of radiotherapy. | 2 years | Yes |
Secondary | Adverse Events rate | Adverse events were graded according to the expanded common toxicity criteria of the Clinical Trials Group of the National Cancer Institute of Canada (NCI CTCAE v3.0). Laboratory safety data were assessed before the administration of chemotherapy and after treatment. | After every cycle of IC, after every cycle of concurrent chemetherapy and up to 8 weeks after the end of radiotherapy | Yes |
Secondary | Progression-free survival. | Progression-free survival (PFS) was calculated as the date of assignment to recurrence/progression or death resulting from any cause. If the patient had no evidence of the aforementioned events, survival was censored at the time of the last documented evaluation of efficacy/contact or death resulting from another cause. | 3 years | Yes |
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