Intensity-Modulated Proton Beam Therapy or Intensity-Modulated Photon Therapy in Treating Patients With Stage III-IVB Oropharyngeal Cancer

M.D. Anderson Cancer Center logo

M.D. Anderson Cancer Center

Status and phase

Active, not recruiting
Phase 3
Phase 2

Conditions

Stage IVB Oropharyngeal Squamous Cell Carcinoma AJCC v7
Stage IVA Oropharyngeal Squamous Cell Carcinoma AJCC v7
Stage III Oropharyngeal Squamous Cell Carcinoma AJCC v7

Treatments

Radiation: Photon Beam Radiation Therapy
Other: Laboratory Biomarker Analysis
Radiation: Proton Beam Radiation Therapy
Radiation: Intensity-Modulated Radiation Therapy
Other: Quality-of-Life Assessment

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT01893307
NCI-2013-01879 (Registry Identifier)
R03CA188162 (U.S. NIH Grant/Contract)
U19CA021239 (U.S. NIH Grant/Contract)
2012-0825
R56DE025248 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

This randomized phase II/III trial studies the side effects and how well intensity-modulated proton beam therapy works and compares it to intensity-modulated photon therapy in treating patients with stage III-IVB oropharyngeal cancer. Radiation therapy uses high-energy x-rays, protons, and other types of radiation to kill tumor cells and shrink tumors. It is not yet known whether intensity-modulated proton beam therapy is more effective than intensity-modulated photon therapy in treating oropharyngeal cancer.

Full description

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 5 years.

Enrollment

440 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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

Exclusion criteria

  • Previous radiation treatment for head and neck mucosal primary cancers within the past 5 years (i.e. oropharynx, nasopharynx, hypopharynx, larynx, and oral cavity)
  • Pregnant or breast-feeding females

Clinically significant uncontrolled major cardiac, respiratory, renal, hepatic, gastrointestinal or hematologic disease but not limited to:

  • Symptomatic congestive heart failure, unstable angina, or cardiac dysrhythmia not controlled by pacer device
  • Myocardial infarction within 3 months of registration
  • Distant metastases (stage IV C, any T, any N and M1)
  • Previous surgical resection or neck dissection for oropharyngeal cancer, administered with therapeutic intent

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

440 participants in 2 patient groups

Arm I (IMRT)
Experimental group
Description:
Patients undergo IMRT QD five days a week for approximately 6.5 weeks.
Treatment:
Other: Quality-of-Life Assessment
Radiation: Intensity-Modulated Radiation Therapy
Radiation: Photon Beam Radiation Therapy
Other: Laboratory Biomarker Analysis
Arm II (IMPT)
Experimental group
Description:
Patients undergo IMPT QD five days a week for approximately 6.5 weeks.
Treatment:
Other: Quality-of-Life Assessment
Radiation: Intensity-Modulated Radiation Therapy
Radiation: Proton Beam Radiation Therapy
Other: Laboratory Biomarker Analysis

Trial contacts and locations

22

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Data sourced from clinicaltrials.gov

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