Induction Chemotherapy Followed by Chemoradiotherapy for Head and Neck Cancer
|Head and Neck Cancer||Other: 6 weeks of Radiotherapy Other: 5 weeks of Radiotherapy||Phase 2|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Phase II Trial Of Induction Chemotherapy Followed By Attenuated Chemoradiotherapy For Locally Advanced Head And Neck Squamous Cell Carcinoma Associated With Human Papillomavirus (HPV)|
- Progression-free survival [ Time Frame: Up to 2 years ]Defined from date of registration to date of first documentation of progression and/or distant metastasis, or death due to any cause.
- Overall survival [ Time Frame: Up to 5 years ]Defined as the time from registration to death.
- Toxicity [ Time Frame: Up to 5 years ]Assessed by NCI Common Toxicity Criteria for Adverse Effects, Version 4.0
- Quality of Life Assessment [ Time Frame: Up to One Year ]Functional Assessment of Cancer Therapy-Head & Neck (FACT-H&N) and University of Washington Quality of Life (questionnaire)(UWQol)
|Study Start Date:||October 2012|
|Estimated Study Completion Date:||October 2017|
|Primary Completion Date:||May 2015 (Final data collection date for primary outcome measure)|
Experimental: 6 weeks of Radiotherapy
Paclitaxel + Carboplatin (2 cycles) IV followed by Radiation Therapy (6 weeks) + Paclitaxel IV
Other: 6 weeks of Radiotherapy
If tumor does not significantly shrink after initial chemotherapy
Experimental: 5 weeks of Radiotherapy
Paclitaxel 175 mg/m2 + Carboplatin area under curve (AUC) 6 (2 cycles) IV followed by Radiation Therapy (5 weeks) + Paclitaxel 175 mg/m2 IV
Other: 5 weeks of Radiotherapy
If tumor shrinks after initial chemotherapy
Given the toxicity of high dose cisplatin, attention has focused on identifying patients at lower risk for failure who may potentially benefit from less aggressive chemoradiotherapy approaches. HPV-positive Head and Neck Cancer responds favorably to radiation therapy. This has prompted investigators to suggest that patients with these cancers might be "over-treated" and unnecessarily subjected to the toxicity of intensive chemoradiotherapy with excessively high radiation doses.
This study will select patients with HPV-positive Head and Neck cancer for attenuated therapy and may have important implications for individualization of care in the future. The regimen of carboplatin and paclitaxel was selected for the induction chemotherapy phase because of its ease of administration, improved toxicity profile, high rates of dose delivery, and excellent published results showing high response rates and overall survival. This study will use induction chemotherapy primarily as a means to select HPV-positive Head and Neck Cancer patients, who may benefit from significant radiation dose de-intensification in the concurrent chemoradiotherapy phase of treatment. The rationale for this risk-adapted approach to local therapy based on HPV status is to administer effective comprehensive treatment individualized at diagnosis and after assessment of response to induction chemotherapy (for patients with HPV-positive tumors), thus avoiding unnecessary and potentially toxic treatment, and hence optimizing the therapeutic ratio.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01716195
|United States, California|
|University of California Comprehensive Cancer Center|
|Sacramento, California, United States, 95817|
|Principal Investigator:||Megan Daly, MD||University of California, Davis|