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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

This study is currently recruiting participants.
Verified September 2017 by M.D. Anderson Cancer Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT01893307
First Posted: July 9, 2013
Last Update Posted: September 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
National Cancer Institute (NCI)
National Institute of Dental and Craniofacial Research (NIDCR)
Massachusetts General Hospital
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
  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 Intervention Phase
Head And Neck Cancer Radiation: Intensity-Modulated X-Ray Therapy (IMRT) Radiation: Intensity-Modulated Proton Beam Therapy (IMPT) Procedure: Modified barium swallow (MBS) Behavioral: Questionnaires Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

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 ]
    Cumulative incidence of late onset grade 3+ toxicity anytime during the 2 years following completion of radiation therapy where late onset toxicity occurs 90 days or more following completion of radiation therapy and is graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.


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 ]

Estimated Enrollment: 360
Actual Study Start Date: August 2013
Estimated Study Completion Date: August 2023
Estimated Primary Completion Date: August 2023 (Final data collection date for primary outcome measure)
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.

Procedure: Modified barium swallow (MBS)
Modified barium swallow (MBS) performed at baseline, end of treatment visit, 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.
Other Name: Surveys
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.

Radiation: 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.

Procedure: Modified barium swallow (MBS)
Modified barium swallow (MBS) performed at baseline, end of treatment visit, 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.
Other Name: Surveys

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age >/= 18
  2. Histologically documented Squamous Cell Carcinoma of the oropharynx (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

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) No myocardial infarction within 3 months of registration.
  4. Distant Metastases (Stage IV C, any T, any N and M1)
  5. Previous TransOral Robotic Surgery (TORS) to the oropharynx
  6. Unilateral Neck Radiation
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01893307


Contacts
Contact: Steven J. Frank, MD 713-563-2300

Locations
United States, California
University of California at San Diego Recruiting
La Jolla, California, United States, 92093
Contact: Loren Mell, MD         
United States, Florida
Florida Health Protocol Institute Recruiting
West Palm Beach, Florida, United States, 33407
Contact: Roi Dagan, MD         
United States, Illinois
Northwestern Memorial Hospital Recruiting
Chicago, Illinois, United States, 60611
Contact: John H. Han-Chang, MD         
United States, Maryland
University of Maryland Recruiting
College Park, Maryland, United States, 20742
Contact: William Regine, MD         
Contact: Charles Simone, MD         
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Paul Busse, MD         
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Robert Foote, MD         
United States, New York
Memorial-Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Nancy Y. Lee, MD         
United States, Pennsylvania
University of Pennsylvania Health System Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Alexander Lin, MD         
United States, Texas
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
United States, Washington
University of Washington Recruiting
Seattle, Washington, United States, 98105
Contact: Upendra Parvathaneni, MD         
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
National Institute of Dental and Craniofacial Research (NIDCR)
Massachusetts General Hospital
Investigators
Principal Investigator: Steven J. Frank, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01893307     History of Changes
Other Study ID Numbers: 2012-0825
NCI-2013-01879 ( Registry Identifier: NCI CTRP )
R03CA188162 ( U.S. NIH Grant/Contract )
2U19CA021239 ( U.S. NIH Grant/Contract )
First Submitted: July 2, 2013
First Posted: July 9, 2013
Last Update Posted: September 20, 2017
Last Verified: September 2017

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
Neoplasms by Site
Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases