Treatment De-Intensification for Squamous Cell Carcinoma of the Oropharynx
Condition: Squamous Cell Carcinoma of Oropharynx
MeSH terms: Carcinoma; Carcinoma, Squamous Cell
Intervention: IMRT; Cisplatin; Carboplatin
Intervention description: Dose de-escalation (from 70 Gy to 63 Gy and from 58.1 Gy to 50.75 Gy, same number of fractions (N=35) in 7 weeks); Cisplatin will be administered weekly for the first 3 weeks and the last 3 weeks of radiation. Patients will not receive chemotherapy during week 4 of treatment.; Carboplatin will be administered weekly during the 7 weeks of radiation. Carboplatin may be given as a substitution for cisplatin when cisplatin-related toxicities occur or when patients present with greater than grade 2 sensory or motor neuropathy, greater than 2 hearing loss, or less than 60 ml/min creatinine clearance.
Intervention MeSH terms: Carboplatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Maximum age: 100 Years
Healthy volunteers: No
Keywords: Squamous Cell Carcinoma; Oropharynx

Summary:

      This research is being done to try to reduce radiation side effects that happen with the
      standard radiation methods. Generally surgery, radiation therapy, and sometimes chemotherapy
      are standard treatment for people with squamous cell carcinoma of the oropharynx.

      The study will look at giving a slightly smaller dose of radiation (de-intensification) to
      see if regularly expected late toxicities (two years after receiving treatment) can be
      reduced. This study will also try to see if the smaller dose of radiation is equally
      effective at treating the cancer and to see if it improves quality of life. Along with this
      radiation treatment plan some participants in this study will have surgery on their tumor and
      or receive chemotherapy (cisplatin or carboplatin). The possible surgery and or chemotherapy
      will be up to the participant's doctor.

      Study participants will be tested for the Human Papillomavirus (HPV). This tissue test is
      required for this study. Some studies have suggested that HPV-related cancer is biologically
      and clinically different as compared to non-HPV-related cancer. Some studies have found that
      patients with HPV-related oropharynx cancer have a better response to treatment. This test
      will help researchers learn more about HPV-related cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Biopsy-proven SCC of the oropharynx (tonsil, base of tongue, pharyngeal wall or
             palate).

          -  Tumor positive for infection with human papilloma virus (HPV) virus.

          -  T stage: 1, 2 or T3. Surgery of the primary tumor is limited to incisional or
             excisional biopsies (i.e tonsillectomy) even without macroscopic disease left.
             Positive resection margins and/or gross residual disease at the primary site are
             allowed.

          -  Any N stage, but resectable; lymph nodes in both sides of the neck are at risk of
             metastatic disease, according to clinical judgment, and require irradiation;
             pretreatment surgery in the neck in the forms of incisional/excisional biopsy or a
             multilevel neck dissection is allowed only if there is gross tumor left at the primary
             site.

          -  No other malignancy except for non-myelomatous skin cancer, early stage prostate
             cancer (T<2a and PSA<10 and GLS<7) or a carcinoma not of head and neck origin disease
             free for > 5 yrs.

          -  Cannot have distant metastasis (M0)

          -  ECOG performance status 0-1.

          -  Patient's nutritional and general physical condition must be considered compatible
             with the proposed radiotherapeutic treatment.

          -  Patient is judged to be mentally reliable to follow instructions and to keep
             appointments.

          -  Patient is on no other treatment for head and neck cancer.

          -  Signed study-specific informed consent prior to registration.

        Exclusion Criteria:

          -  Evidence of distant metastases.

          -  Absence of macroscopic disease after upfront surgery

          -  Previous irradiation for head and neck tumor; concurrent chemotherapy other than the
             treatment per protocol; previous chemotherapy ≤ 3 months from start of RT.

          -  Active untreated infection.

          -  Major medical or psychiatric illness, which in the investigators' opinions would
             interfere with either completion of therapy and follow-up or with full and complete
             understanding of the risks and potential complications of the therapy.

          -  Prophylactic use of amifostine or pilocarpine is not allowed.

          -  Patients with greater than 1- pack years of smoking history and/or currently a smoker
             at the time of treatment