Induction Chemotherapy Followed by Chemoradiotherapy for Head and Neck Cancer
Condition: Head and Neck Cancer
MeSH terms: Head and Neck Neoplasms
Intervention: Induction Chemotherapy followed by Response Adapted Chemoradiation
Intervention description: All patients receive induction chemotherapy with 2 cycles of paclitaxel and carboplatin followed by response adapted, de-escalated chemoradiation. Patients with a complete or partial response will receive 54 Gy with concurrent paclitaxel and patients with stable disease will receive 60 Gy with concurrent paclitaxel.
Intervention MeSH terms: Paclitaxel; Carboplatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Human Papillomavirus; HPV

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.