Phase II Trial Of Induction Chemotherapy Followed By Attenuated Chemoradiotherapy For Locally Advanced Head And Neck Squamous Cell Carcinoma Associated With Human Papillomavirus (HPV)
18 Years
N/A
Both
Head and Neck Cancer
Trial Information
Phase II Trial Of Induction Chemotherapy Followed By Attenuated Chemoradiotherapy For Locally Advanced Head And Neck Squamous Cell Carcinoma Associated With Human Papillomavirus (HPV)
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.
Inclusion Criteria:
- Pathologically proven diagnosis of HPV-positive squamous cell carcinoma of the
oropharynx, hypopharynx, or larynx. HPV-positivity will be defined as tumors that are
p16-positive by immunohistochemistry.
- Clinical stage III or IV disease; Note: Patients with M1 tumors are not eligible.
- Appropriate stage for protocol entry, including no distant metastases, based upon
minimum diagnostic workup
- Zubrod Performance Status 0-1
- Age > 18
- Adequate bone marrow function
- Adequate hepatic function
- Adequate renal function
- Pregnancy test within 4 weeks prior to registration for women of childbearing
potential
- Women of childbearing potential and male participants must agree to use a medically
effective means of birth control throughout their participation in the treatment
phase of the study (until at least 60 days following the last study treatment)
- Patient must sign study specific informed consent prior to study entry.
Exclusion Criteria:
- Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free
for a minimum of 3 years;
- Patients with simultaneous primaries or bilateral tumors are excluded.
- Patients who present with a cervical lymph node metastasis of unknown primary origin;
- Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a
different cancer is allowable;
- Prior radiotherapy that would result in overlap of radiation therapy fields;
- Primary site of tumor of oral cavity, nasopharynx, nasal cavity, paranasal sinuses,
or salivary glands;
- Recurrent head and neck cancer;
- Severe, active co-morbidity
- Pregnant or lactating women or women of childbearing potential and men who are
sexually active and not willing/able to use medically acceptable forms of
contraception; this exclusion is necessary because the treatment involved in this
study may be significantly teratogenic.
- Prior allergic reaction to the study drug(s) involved in this protocol.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Progression-free survival
Outcome Description:
Defined from date of registration to date of first documentation of progression and/or distant metastasis, or death due to any cause.
Outcome Time Frame:
Up to 2 years
Safety Issue:
No
Principal Investigator
Allen Chen, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of California, Davis
Authority:
United States: Institutional Review Board
Study ID:
CCRO022
NCT ID:
NCT01716195
Start Date:
October 2012
Completion Date:
October 2016
Related Keywords:
- Head and Neck Cancer
- Human Papillomavirus
- HPV
- Carcinoma, Squamous Cell
- Head and Neck Neoplasms
Name | Location |
|---|---|
| University of California Comprehensive Cancer Center | Sacramento, California 95817 |
