Clinical Trials /

Treatment De-Intensification for Squamous Cell Carcinoma of the Oropharynx

NCT01088802

Description:

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.

Related Conditions:
  • Oropharyngeal Squamous Cell Carcinoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 2

Trial Eligibility

Document

Treatment De-Intensification for Squamous Cell Carcinoma of the Oropharynx

Title

  • Brief Title: Treatment De-Intensification for Squamous Cell Carcinoma of the Oropharynx
  • Official Title: A Phase II Study on Treatment De-Intensification in Favorable Squamous Cell Carcinoma of the Oropharynx
  • Clinical Trial IDs

    NCT ID: NCT01088802

    ORG ID: J0988, NA_00026771

    NCI ID: NA_00026771

    Trial Conditions

    Squamous Cell Carcinoma of Oropharynx

    Trial Interventions

    Drug Synonyms Arms
    Cisplatin Dose de-escalating radiation therapy with chemotherapy
    Carboplatin Dose de-escalating radiation therapy with chemotherapy

    Trial Purpose

    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.

    Detailed Description

    Trial Arms

    Name Type Description Interventions
    Dose de-escalating radiation therapy with chemotherapy Experimental This protocol combines selective radiation therapy 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) in patients with HPV-associated cancers of the oropharynx Cisplatin, Carboplatin

    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

    Minimum Eligible Age: 18 Years

    Maximum Eligible Age: N/A

    Eligible Gender: Both

    Primary Outcome Measures

    Grade 3+ late toxicity

    Quality of Life

    Adverse events and their cause

    Secondary Outcome Measures

    Trial Keywords

    Squamous Cell Carcinoma

    Oropharynx