Mode
Text Size
Log in / Sign up
Phase 2 Completed N=18 Treatment

Induction Chemotherapy Followed by Chemoradiotherapy for Head and Neck Cancer

Source: ClinicalTrials.gov NCT01716195 ↗
Enrolled (actual)
18
Serious AEs
11.1%
Results posted
Feb 2021
Primary outcomePrimary: Number of Participants With Progression-free Survival — 17 Participants

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).

Outcome Measures

OutcomeResultp-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

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.
View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.

Back to search