Intensity-Modulated Proton Beam Therapy or Intensity-Modulated Photon Therapy in Treating Patients with Stage III-IVB Oropharyngeal Cancer
Head and Neck Cancer
Unknown Primary
18 Years and older, Male and Female
2012-0825 (primary)
NCI-2013-01879
Summary
The overall goal of this trial is to identify a less toxic approach to the delivery of conformal radiation therapy for patients with cancers of the oropharynx. We aim to show that Intensity Modulated Proton Therapy (IMPT) will substantially reduce the burden of acute and late toxicity, result in faster recovery and return to function, with similar rates of long-term survivorship, compared with radiation using Intensity Modulated Photon Therapy (IMRT).
Objectives
PRIMARY OBJECTIVES:
I. To compare the rates and severity of late grade 3-5 toxicity between intensity-modulated photon therapy (IMRT) and intensity-modulated proton therapy (IMPT) following the treatment of oropharyngeal tumors. (Phase II)
II. To compare the rate of 3-year progression-free survival (PFS) between concurrent chemo-radiation strategies with IMRT and IMPT following the treatment of oropharyngeal tumors. (Phase III)
SECONDARY OBJECTIVES:
I. Disease-related outcomes (2-year progression-free survival, patterns of failure, 2-year overall survival, 2-year [yr] distant metastasis free survival, and second primary cancers). (Phase III)
II. Patient Reported Outcome (PRO) measures of symptoms using MD Anderson Symptom Inventory (MDASI), MD Anderson Dysphagia Inventory (MDADI), Functional Assessment of Cancer Therapy-Head and Neck (FACT-HN), Xerostomia and Health Questionnaire (European Quality of Life 5-Dimension three level scale [EQ-5D-3L]), work status (Work Productivity and Activity Impairment: Specific Health Problem [WPAI: SHP]). (Phase III)
III. Physician reported toxicity using Common Terminology Criteria for Adverse Events (CTCAE)-4.0. (Phase III)
IV. Quality-Adjusted-Life-Years (QALY) comparison between IMPT and IMRT. (Phase III)
V. Cost-benefit economic analysis of treatment. (Phase III)
VI. To determine whether specific molecular profiles are associated with overall or progression-free survival. (Phase III)
VII. To investigate associations between changes in serum biomarkers or human papillomavirus (HPV)-specific cellular immune responses measured at baseline and three months with overall or progression-free survival. (Phase III)
VIII. To bank peripheral blood at time of enrollment, weeks 2, 4, and 6 during treatment and during follow up visits for 2 years to explore the ability of circulating markers to predict outcome. (Phase III)
IX. To bank head and neck tissues to explore the ability of tissue-based markers to predict outcome. (Phase III)
X. To bank peripheral blood and tissues for future interrogations. (Phase III)
XI. Acute side effects of radiation therapy will be assessed. (Phase III)
EXPLORATORY OBJECTIVE:
I. To assess potential differences between patients on study and patients who were considered eligible for randomized, were randomized to a treatment arm, but were denied insurance coverage for the treatment arm she/he was randomized to; or may have dropped out of the study for other reasons after being randomized. These patients will compromise Group 3: consisting of patients randomized to Protons but not treated and Group 4: consisting of patients randomized to IMRT but not treated at the designated institution. Furthermore, these patients will only be followed for recurrence and survival. (Phase III)
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients undergo IMRT once daily (QD) five days a week for approximately 6.5 weeks.
ARM II: Patients undergo IMPT QD five days a week for approximately 6.5 weeks.
After completion of study treatment, patients are followed up every 3 months for 1 year, every 4 months for 1 year, and then every 6 months for 3 years.
Eligibility
- Histologically documented squamous cell carcinoma of the oropharynx (American Joint Committee on Cancer [AJCC] version [v]7 stage III-IV A,B)
- Tumor tissue (primary or cervical metastasis) available for human papilloma virus (HPV) and/or p16 (in situ hybridization [ISH], immunohistochemistry [IHC] or genotyping testing); if you do not have enough leftover tumor tissue available, you will have a tumor biopsy for tumor marker testing
- Eastern Cooperative Oncology Group (ECOG) performance status = 0, 1, or 2
- Negative pregnancy test for women of child bearing potential
- Concurrent chemotherapy
- Bilateral neck radiation
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