Induction Chemotherapy Followed by Chemoradiotherapy for Head and Neck Cancer
Completed · Phase 2
Conditions studied: Head and Neck Cancer
In brief
The purpose of this study is to determine whether human papillomavirus (HPV)-positive head and neck cancer can be treated with a less aggressive regimen of radiation therapy and chemotherapy (paclitaxel) after initially receiving two cycles of chemotherapy (carboplatin/paclitaxel).
Key facts
- Study ID
- NCT01716195
- Run by
- University of California, Davis
- People needed
- 18
- Starts
- 2012-10-01
- Expected to finish
- 2020-10-01
- Last updated by the study team
- 2021-02-26
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- University of California Comprehensive Cancer Center — Sacramento, California, United States
Full record on ClinicalTrials.gov
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