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Induction Chemotherapy Followed by Chemoradiotherapy for Head and Neck Cancer

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ClinicalTrials.gov Identifier: NCT01716195
Recruitment Status : Active, not recruiting
First Posted : October 29, 2012
Last Update Posted : January 16, 2018
Information provided by (Responsible Party):
University of California, Davis

Brief 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).

Condition or disease Intervention/treatment Phase
Head and Neck Cancer Other: 6 weeks of Radiotherapy Other: 5 weeks of Radiotherapy Phase 2

Detailed Description:

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
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)
Study Start Date : October 2012
Primary Completion Date : May 2015
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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
Other Names:
  • Taxol
  • Paraplatin
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
Other Names:
  • Taxol
  • Paraplatin

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. Overall survival [ Time Frame: Up to 5 years ]
    Defined as the time from registration to death.

  2. Toxicity [ Time Frame: Up to 5 years ]
    Assessed by NCI Common Toxicity Criteria for Adverse Effects, Version 4.0

  3. 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)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01716195

United States, California
University of California Comprehensive Cancer Center
Sacramento, California, United States, 95817
Sponsors and Collaborators
University of California, Davis
Principal Investigator: Megan Daly, MD University of California, Davis

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT01716195     History of Changes
Other Study ID Numbers: 359512
CCRO022 ( Other Identifier: UCD )
First Posted: October 29, 2012    Key Record Dates
Last Update Posted: January 16, 2018
Last Verified: January 2018

Keywords provided by University of California, Davis:
Human Papillomavirus

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action