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
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| ClinicalTrials.gov Identifier: NCT01893307 |
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Recruitment Status :
Recruiting
First Posted : July 9, 2013
Last Update Posted : May 23, 2019
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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 or disease | Intervention/treatment | 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 |
Show Detailed Description
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 360 participants |
| 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 |
| Actual Study Start Date : | August 2013 |
| Estimated Primary Completion Date : | August 2023 |
| Estimated Study Completion Date : | August 2024 |
| Arm | Intervention/treatment |
|---|---|
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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 |
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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 |
- 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.
- Progression-Free Survival (PFS) Between Concurrent Chemo-Radiation Strategies with IMRT and IMPT Following the Treatment of Oropharyngeal Tumors [ Time Frame: 3 years ]
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, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age >/= 18
- Histologically documented Squamous Cell Carcinoma of the oropharynx (American Joint Committee on Cancer (AJCC) v7** 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: a) Symptomatic congestive heart failure, unstable angina, or cardiac dysrrhythmia not controlled by pacer device. b) 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.
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
| Contact: Steven J. Frank, MD | 713-563-2300 | sjfrank@mdanderson.org |
| United States, Arizona | |
| Mayo Clinic - Arizona | Recruiting |
| Scottsdale, Arizona, United States, 85259 | |
| United States, California | |
| University of California at San Diego | Recruiting |
| La Jolla, California, United States, 92093 | |
| Contact: Loren Mell, MD | |
| United States, Florida | |
| UF Health Proton Therapy Institute | Recruiting |
| Jacksonville, Florida, United States, 32206 | |
| Contact: Roi Dagan, MD | |
| Contact: Jin Park, BSH (877) 686-6009 jinpark@floridaproton.org | |
| 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 | |
| Principal Investigator: | Steven J. Frank, MD | M.D. Anderson Cancer Center |
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 Posted: | July 9, 2013 Key Record Dates |
| Last Update Posted: | May 23, 2019 |
| Last Verified: | May 2019 |
Keywords provided by M.D. Anderson Cancer Center:
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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:
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Head and Neck Neoplasms Oropharyngeal Neoplasms Neoplasms by Site Neoplasms Pharyngeal Neoplasms |
Otorhinolaryngologic Neoplasms Pharyngeal Diseases Stomatognathic Diseases Otorhinolaryngologic Diseases |