Phase 2
N=18
Induction Chemotherapy Followed by Chemoradiotherapy for Head and Neck Cancer
Head and Neck Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01716195 ↗Enrolled (actual)
18
Serious AEs
11.1%
Results posted
Feb 2021
Primary outcome: Primary: Number of Participants With Progression-free Survival — 17 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Induction Chemotherapy followed by Response Adapted Chemoradiation (Radiation)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of California, Davis
- Primary completion
- Mar 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Progression-free Survival |
17 | — |
| SECONDARY Number of Participants With Overall Survival |
16 | — |
| SECONDARY Number of Patients With Toxicity of Concurrent Chemoradiotherapy |
17 | — |
Summary
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).
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01716195). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.