Clinical Trial - NCT01893307

Randomized Trial of Intensity-Modulated Proton Beam Therapy (IMPT) Versus Intensity-Modulated Photon Therapy (IMRT) for the Treatment of Oropharyngeal Cancer of the Head and Neck

Recruiting

Sponsor: M.D. Anderson Cancer Center

Collaborators: National Cancer Institute (NCI), National Institute of Dental and Craniofacial Research (NIDCR), Massachusetts General Hospital

Information provided by (Responsible party): Sponsor

ClinicalTrials.gov Identifier: NCT01893307

Protocol Info

Short Description: Phase II/III Randomized Trial of IMPT vs IMRT for Oropharyngeal Cancer of the H&N
Long Description: Phase II/III Randomized Trial of Intensity-Modulated Proton Beam Therapy (IMPT) versus Intensity-Modulated Photon Therapy (IMRT) for the treatment of Oropharyngeal Cancer of the Head and Neck
MGH Status: Open
Sponsor: MD Anderson/NCI
Disease Program: Proton

Next Steps


If you are interested in this protocol or in other treatment options at Massachusetts General Hospital, please Request a Consultation.




Purpose

The goal of this clinical research study is to compare the side effects of 2 radiation treatments for head and neck cancer. The 2 treatments are intensity modulated photon therapy (IMRT) and intensity modulated proton therapy (IMPT). Participants will also receive chemotherapy along with radiation therapy. IMPT is designed to use beams of proton particles to send radiation to the tumor. IMRT is designed to use beams of photon therapy to send radiation to the tumor. Both of these types of radiation treatment may give a full dose of radiation treatment to the tumor while not damaging as much of the healthy tissue around it. This is an investigational study. IMRT and IMPT are delivered using FDA-approved and commercially available methods. Comparing them is investigational. Up to 360 participants will be enrolled in this study. Up to 250 patients will take part at MD Anderson.
Condition Title Intervention Phase
Head And Neck Cancer Intensity-Modulated X-Ray Therapy (IMRT) Intensity-Modulated Proton Beam Therapy (IMPT) Modified barium swallow (MBS) Questionnaires Phase 2/Phase 3
Study Type Interventional
Official Title Phase II/III Randomized Trial of Intensity-Modulated Proton Beam Therapy (IMPT) Versus Intensity-Modulated Photon Therapy (IMRT) for the Treatment of Oropharyngeal Cancer of the Head and Neck

Primary Outcome Measures

Rates and Severity of Late Grade 3-5 Toxicity Between Intensity-Modulated X-Ray Therapy (IMRT) and Intensity-Modulated Proton Beam Therapy (IMPT) [Time Frame: 90 days to 2 years post radiation therapy] [Designated as safety issue: ]


Secondary Outcome Measures

Progression-Free Survival (PFS) Between Concurrent Chemo-Radiation Strategies with IMRT and IMPT Following the Treatment of Oropharyngeal Tumors [Time Frame: 3 years] [Designated as safety issue: ]

Estimated Enrollment: 360
Study Start Date: August 2013
Estimated Study Completion Date: August 2024
Estimated Primary Completion Date: August 2023
Arms Assigned Interventions

Experimental:Intensity-Modulated X-Ray Therapy (IMRT)

Radiation therapy dosage 70 Gy (RBE) delivered 1 time each day, 5 days a week (Monday through Friday) for up to 33 treatments (about 6 ½ weeks). Treating physician evaluate each patient for possible chemotherapy. Modified barium swallow (MBS) performed at baseline, end of treatment visit, and at 6, 12, and 24 months after radiation therapy. Questionnaires completed at baseline, each week while receiving radiation therapy, at end of treatment visit, at 10 - 12 weeks after radiation, and at 6, 12, and 24 months after radiation therapy.
Radiation:Intensity-Modulated X-Ray Therapy (IMRT)
Radiation therapy dosage 70 Gy (RBE) delivered 1 time each day, 5 days a week (Monday through Friday) for up to 33 treatments (about 6 ½ weeks). Treating physician evaluate each patient for possible chemotherapy.

Experimental:Intensity-Modulated Proton Beam Therapy (IMPT)

Radiation therapy dosage 70 Gy (RBE) delivered 1 time each day, 5 days a week (Monday through Friday) for up to 33 treatments (about 6 ½ weeks). Treating physician evaluate each patient for possible chemotherapy. Modified barium swallow (MBS) performed at baseline, end of treatment visit, and at 6, 12, and 24 months after radiation therapy. Questionnaires completed at baseline, each week while receiving radiation therapy, at end of treatment visit, at 10 - 12 weeks after radiation, and at 6, 12, and 24 months after radiation therapy.
Behavioral:Questionnaires
Questionnaires completed at baseline, each week while receiving radiation therapy, at end of treatment visit, at 10 - 12 weeks after radiation, and at 6, 12, and 24 months after radiation therapy.

Eligibility

Ages Eligible for Study: N/A-N/A

Genders Eligible for Study: All

Accepts Healthly Volunteers: No

Inclusion Criteria:

1. Age >/= 18

2. Histologically documented Squamous Cell Carcinoma of the oropharynx (American Joint Committee on Cancer (AJCC) v7** Stage III-IV A,B)

3. 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.

4. Eastern Cooperative Oncology Group (ECOG) performance status= 0, 1, or 2

5. Negative pregnancy test for women of child bearing potential

6. Concurrent Chemotherapy

7. Bilateral Neck Radiation

Exclusion Criteria:

1. Previous radiation treatment for head and neck mucosal primary cancers within the past 5 years (i.e. oropharynx, nasopharynx, hypopharynx, larynx, and oral cavity)

2. Pregnant or breast-feeding females

3. Clinically significant uncontrolled major cardiac, respiratory, renal, hepatic, gastrointestinal or hematologic disease but not limited to: a) Symptomatic congestive heart failure, unstable angina, or cardiac dysrrhythmia not controlled by pacer device. b) Myocardial infarction within 3 months of registration.

4. Distant Metastases (Stage IV C, any T, any N and M1)

5. Previous surgical resection or neck dissection for oropharyngeal cancer, administered with therapeutic intent.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01893307

Locations

  • United States, Arizona
    • Mayo Clinic - Arizona Scottsdale, Arizona, United States, 85259
  • United States, California
    • University of California at San Diego La Jolla, California, United States, 92093
  • United States, Florida
    • UF Health Proton Therapy Institute Jacksonville, Florida, United States, 32206
  • United States, Illinois
    • Northwestern Memorial Hospital Chicago, Illinois, United States, 60611
  • United States, Maryland
    • University of Maryland College Park, Maryland, United States, 20742
  • United States, Massachusetts
    • Massachusetts General Hospital Boston, Massachusetts, United States, 02114
  • United States, Minnesota
    • Mayo Clinic Rochester, Minnesota, United States, 55905
  • United States, New York
    • Memorial-Sloan Kettering Cancer Center New York, New York, United States, 10065
  • United States, Pennsylvania
    • University of Pennsylvania Health System Philadelphia, Pennsylvania, United States, 19104
  • United States, Texas
    • University of Texas MD Anderson Cancer Center Houston, Texas, United States, 77030
  • United States, Washington
    • University of Washington Seattle, Washington, United States, 98105

Sponsors and Collaborators

M.D. Anderson Cancer Center

National Cancer Institute (NCI)

National Institute of Dental and Craniofacial Research (NIDCR)

Massachusetts General Hospital

More Information

No publications provided

Responsible Party: Sponsor
ClinicalTrials.gov Identifier: NCT01893307
Other Study ID Numbers: NCI-2013-01879
Study First Received:
Last Updated:
Health Authority:

Keywords provided by M.D. Anderson Cancer Center:

Head And Neck Cancer

Oropharyngeal Cancer

Squamous cell carcinoma of the oropharynx

Acute and late toxicity

Intensity modulated photon therapy

IMRT

Intensity modulated proton therapy

IMPT

Modified barium swallow

MBS

Questionnaires

Surveys

Additional relevant MeSH terms:

Head and Neck Neoplasms

Oropharyngeal Neoplasms

Next Steps


If you are interested in this protocol or in other treatment options at Massachusetts General Hospital, please Request a Consultation.







ClinicalTrials.gov processed this data on April 09, 2020