Clinical trial NCT01088802: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Squamous Cell Carcinoma of Oropharynx
Keywords: Squamous Cell Carcinoma
Oropharynx
Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Sponsor class: OTHER
First posted: 2010-03-17
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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

Primary outcomes:
measure: Percentage of Patients Free of Grade 3+ Late Toxicity
timeFrame: 2 years
measure: Percentage of Patients With Locoregional Tumor Control
timeFrame: 2 years
measure: Adverse Events and Their Cause
timeFrame: Pretreatment, 3 months, then every 3 months for the first 2 years, then every 6 months for years 3-5
measure: Quality of Life Measured Through Patient-reported Outcome Measures on Assessments: M.D. Anderson Dysphagia Inventory (MDADI)
timeFrame: Baseline, 6-8 weeks, 6 months, 1 year, 2 years, 3 years, 4-5 year visit
measure: Quality of Life Measured Through Patient-reported Outcome Measures on Assessments: MD Anderson Symptom Inventory-head and Neck Cancer (MDASI-HN)
timeFrame: Baseline, 6-8 weeks, 1 year, 2 years, 3 years, 4-5 year visit
measure: Quality of Life Measured Through Patient-reported Outcome Measures on Assessments: Xerostomia Questionnaire (XQ)
timeFrame: Baseline, 6-8 weeks, 1 year, 2 years, 3 years, 4-5 year visit
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Quon Harry, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Johns Hopkins University
name: Arlene Forastiere, M.D.
role: PRINCIPAL_INVESTIGATOR
References: