Induction Chemotherapy for Advanced Head and Neck Cancer
The purpose of this study is to evaluate the response rate, safety, toxicity, and quality of life of paclitaxel and cisplatin induction chemotherapy. The trial will also evaluate overall survival, progression-free survival, locoregional control and laryngo-esophageal dysfunction-free survival.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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).|
- Tumor response rate [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Tumor response was assessed after induction chemotherapy (just before chemoradiotherapy) and 60 days after completion fo chemoradiotherapy.
Evaluation of tumor response was by clinical examination, nasoendoscopy, and CT or MRI imaging of the primary site and the neck (RECIST criteria 1.0).
- Overall survival. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]It was defined as the time from histological diagnosis to death.
- Quality of life (EORTC QLQ-C30) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]Questionnaire of quality of life (EORTC QLQ-C30) was applied at baseline, before chemoradiotherapy and 60 days following last day of radiotherapy.
- Safety (by National Cancer Institute Common Toxicity Criteria) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]Adverse events (by National Cancer Institute Common Toxicity Criteria v3.0): Acute events (related to induction chemotherapy and related to chemoradiotherapy) and late events (during follow up)
- Progression-free survival. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]It was defined as the time from randomization to the first radiologic confirmation of disease progression.
- Laryngo-esophageal dysfunction-free survival [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
|Study Start Date:||August 2009|
|Study Completion Date:||April 2013|
|Primary Completion Date:||November 2010 (Final data collection date for primary outcome measure)|
Experimental: Induction TP chemotherapy
paclitaxel 175mg/m2 as a 3-h infusion on Day 1, and cisplatin 80mg/m2 as a 2-h infusion on Day 1 three weekly. All patient were given adequate hydration and antiemetics.
Drug: Induction TP chemotherapy
3 cycles of paclitaxel 175mg/m2 and cisplatin 80mg/m2 q3w.
Other Names:Drug: Induction TP chemotherapy
Paclitaxel 175mg/m2 as a 3-h infusion on Day 1, and cisplatin 80mg/m2 as a 2-h infusion on Day 1, three weekly. All patients were given adequate hydration and antiemetics.
A prospective unicenter phase-II trial will be performed to evaluate the effect of 3 cycles of IC with PC followed by concomitant CCRT in locally advanced SSCHN.
The patients will be stratify by tumor subsite (oropharynx and hypopharynx/larynx)and by resectable status (resectable or irresectable advanced squamous cell.
|Barretos Cancer Hospital|
|Barretos, São Paulo, Brazil, 14784-400|
|Principal Investigator:||Luciano S Viana, MSc||Brazilian Society of Clinical Oncology|