Intensity-Modulated Proton Beam Therapy (IMPT) Versus Intensity-Modulated Photon Therapy (IMRT)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by M.D. Anderson Cancer Center
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01893307
First received: July 2, 2013
Last updated: June 25, 2014
Last verified: June 2014
  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 may 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.


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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 Cancer

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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 360
Study Start Date: August 2013
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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) /p16 (in situ hybridization (ISH), immunohistochemistry (IHC) or genotyping testing)
  4. Eastern Cooperative Oncology Group (ECOG) performance criteria = 0, 1, or 2
  5. Negative pregnancy test for women of child bearing potential

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)
  Contacts and Locations
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, see Learn About Clinical Studies.

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

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

Locations
United States, Texas
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Steven J. Frank, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01893307     History of Changes
Other Study ID Numbers: 2012-0825, NCI-2013-01879
Study First Received: July 2, 2013
Last Updated: June 25, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on August 28, 2014