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

StatusActive, Not Recruiting
PhasePhase 3
Started2013-08-26
View on ClinicalTrials.gov ↗

Amendment history

2026-08-20
2 amendments v29-v30
2 re-verifications since 2026-02-20, no change to tracked fields
2025-08-07
Study Status v28
Primary completion date2025-08-31→2031-12-31
Completion date2025-08-31→2031-12-31
2025-03-06
Study Identification, Study Status, Study Description, Conditions, Study Design, Document Section v27
PhasePhase 2/3→Phase 3
Study description-282 characters
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-ra [...] T and IMPT following the treatment of oropharyngeal tumors. (Phase III) SECONDARY OBJECTIVES: I.To Diseaseassess and compare overall survival between IMRT and IMPT along with estimating disease-related outcomes (such as: [2-year progression-free survival, patterns of [...] [...]
Study titlerevised
Intensity-Modulated Proton Beam Therapy or Intensity-Modulated Photon Therapy in Treating Patients withWith Stage III-IVB Oropharyngeal Cancer
2024-09-06
Study Identification, Study Status, Conditions v26
Study titlerevised
Intensity-Modulated Proton Beam Therapy or Intensity-Modulated Photon Therapy in Treating Patients Withwith Stage III-IVB Oropharyngeal Cancer
2024-03-06
2 amendments v24-v25
2 re-verifications since 2023-09-28, no change to tracked fields
Show 23 earlier versions
2023-09-01
Recruiting→Active, Not Recruiting Study Status, Study Design, Contacts/Locations v23
Trial statusRecruiting→Active, Not Recruiting
Enrollment targetestimated 442→confirmed 440
Study sitesdetails revised at 22 of 22 sites
2022-05-13
Study Status v22
Re-verified, no change to tracked fields
2022-04-19
Active, Not Recruiting→Recruiting Study Status, Study Design, Contacts/Locations v21
Trial statusActive, Not Recruiting→Recruiting
Enrollment target440→442
Study sitesdetails revised at 22 of 22 sites
2022-02-23
Recruiting→Active, Not Recruiting Study Status, Study Design, Contacts/Locations v20
Trial statusRecruiting→Active, Not Recruiting
Enrollment targetestimated 518→confirmed 440
Study sitesdetails revised at 22 of 22 sites
2021-11-11
Study Identification, Study Status, Sponsor/Collaborators, Oversight, Study Description, Conditions, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations, References v19
Primary completion date2023-08-26→2025-08-31
Completion date2024-08-26→2025-08-31
Enrollment target360→518
Study sites9→22
InterventionsIntensity-Modulated Proton Beam Therapy (IMPT) (Radiation), Intensity-Modulated X-Ray Therapy (IMRT) (Radiation), Modified barium swallow…→Intensity-Modulated Radiation Therapy (Radiation), Intensity-Modulated Radiation Therapy (Radiation), Laboratory Biomarker Analysis…
Eligibility criteria-12 characters
Inclusion Criteria: Age >/= 18 Histologically documented Squamoussquamous Cellcell Carcinomacarcinoma of the oropharynx (American Joint Committee on Cancer ([AJCC)] v7**version Stage[v]7 stage III-IV A,B) Tumor tissue (primary or cervical metastasis) a [...] man papilloma virus (HPV) and/or p16 (in situ hybridization ([ISH)], immunohistochemistry ([IHC)] or genotyping testing); Ifif 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 statu [...] gnancy test for women of child bearing potential Co [...]
Secondary endpoints1 entry, revised
Progression-FreeQuality Survivalof life (PFSQoL) Between(Phase Concurrent Chemo-Radiation Strategies with IMRTII and IMPT Following the Treatment of Oropharyngeal TumorsIII)
Primary endpoints1 to 5 entries
RatesCumulative and Severityincidence of Lateacute Gradegrade 3-5+ Toxicity Between Intensity-Modulated X-Ray Therapytoxicity (IMRTPhase II) Cumulative incidence of late onset grade 3+ toxicity anytime (Phase II) Overall survival (OS) and(Phase Intensity-ModulatedII) Overall Proton Beam Therapysurvival (IMPTPhase III) Progression-free survival (Phase III)
Study description-3,219 characters
Baseline Visit: If you are found to be eligible to take part in this study, you will have a baseline visit. The following tests and procedures will be performed: You will be asked about your diet and if you have had recent weight loss. You will have a dental exam. Your swallowing function will be te [...] 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 [...]
Collaborators3 to 2 entries
Massachusetts General Hospital
Study title-40 characters
Randomized Trial of Intensity-Modulated Proton Beam Therapy (IMPT) Versusor Intensity-Modulated Photon Therapy (IMRT)in forTreating thePatients TreatmentWith ofStage III-IVB Oropharyngeal Cancer of the Head and Neck
2021-04-05
Study Status, Contacts/Locations v18
Study sites11→9
2020-09-30
Study Status v17
Primary completion date2023-08→2023-08-26
Completion date2024-08→2024-08-26
Start date2013-08→2013-08-26
2019-05-21
Study Status, Contacts/Locations v16
Completion date2023-08→2024-08
2019-05-09
Study Status, Contacts/Locations v15
Study sites11 entries, revised
FloridaUF Health ProtocolProton Therapy Institute
2018-07-27
Study Status, Study Description, Eligibility, Contacts/Locations v14
Study sites10→11
Eligibility criteria+94 characters
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 metastas [...] or women of child bearing potential Concurrent Chemotherapy Bilateral Neck Radiation Exclusion Criteria: Previous radiation treatment for head an [...] or cardiac dysrrhythmia not controlled by pacer device. b) No myocardialMyocardial infarction within 3 months of registration. Distant Metastases (Stage IV C, any T, any N and M1) Previous TransOralsurgical Roboticresection Surgeryor (TORS)neck to [...]
Study description-62 characters
[...] ek 7): You will fill out the same questionnaires as before. You will have a mouth exam to check your swallowing function. You will have a dental exam, including jaw measurements and [...]
2017-09-18
Study Status, Study Description, Outcome Measures, Eligibility, Contacts/Locations v13
Completion datenot stated→2023-08
Study sites7→10
Eligibility criteria+24 characters
Inclusion Criteria: Age >/= 18 Histologically documented squamousSquamous cellCell carcinomaCarcinoma of the oropharynx (Stage III-IV A,B) Tumor tissue (primary [...] egative pregnancy test for women of child bearing potential Concurrent Chemotherapy Exclusion Criteria: Previous radiation treatment for head an [...]
Secondary endpoints+144 characters
Progression-Free Survival (PFS) Between Concurrent Chemo-Radiation Strategies with IMRT and IMPT Following the Treatment of Oropharyngeal Tumors
Study description+260 characters
[...] ked about your diet and if you have had recent weight loss. You will have a hearing test. You will have a dental exam. Your swallowing function will b [...] minutes to complete. You will have a video-strobe procedure or laryngoscopy to allow the doctor to look at your vocal cords. To perform [...] n of receiving a numbing spray for your nose and/or throat. A laryngoscopy is a standard procedure in which a tube with a lighted camera is inserted through your mouth and into your throat. Photos of the inside of your mouth will be taken to check fo [...] or the transmitting questionnaires. Saliva will be collected and [...] [...]
2016-11-10
Study Status, Eligibility, Contacts/Locations v12
Study sites2→7
Eligibility criteria+120 characters
[...] vical 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 statu [...]
2016-06-23
Study Identification, Study Status, Sponsor/Collaborators, Study Description, Eligibility v11
Eligibility criteria-3 characters
[...] ting) Eastern Cooperative Oncology Group (ECOG) performance criteria status= 0, 1, or 2 Negative pregnancy test for women of child bear [...]
Study description+6 characters
[...] ut swallowing that should take about 5 minutes to complete. You will be asked to sign a separate consent form that describes the MBS procedure and its risks. You will have a video-strobe procedure to allow the doctor t [...] eting these questionnaires should take about 10-15 minutes. An email address will be collected for the transmitting questionnaires. An email address will be collected for the transmitting questionnaires. Saliva will be collected at this visit, at the end of your t [...] doctor thinks it is needed, you will have a CT scan and/or positron emission computed tomography (PET)/CT scan to che [...]
Collaborators2 to 3 entries
Massachusetts General Hospital
Study title+83 characters
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
2016-06-01
Study Status, Study Description v10
Study description+40 characters
[...] doctor thinks it is needed, you will have a CT scan and/or positron emission computed tomography (PET)/CT scan to check the status of the disease. At the end of y [...]
2015-12-01
Study Identification, Study Status, Sponsor/Collaborators, Study Description, Eligibility, Contacts/Locations v9
Eligibility criteria+26 characters
[...] Previous TransOral Robotic Surgery (TORS) to the oropharynx Unilateral Neck Radiation
Study description+15 characters
[...] nal. Up to 360 participants will be enrolled in this study. AllUp to 250 patients will take part at MD Anderson.
Study sitesdetails revised at 1 of 2 sites
Collaborators1 to 2 entries
National Institute of Dental and Craniofacial Research (NIDCR)
2015-10-07
Study Identification, Study Status, Sponsor/Collaborators, Contacts/Locations v8
Study sites1→2
Collaborators+31 characters
National Cancer Institute (NCI)
2015-07-20
Study Status, Eligibility v7
Eligibility criteria+60 characters
[...] ration. Distant Metastases (Stage IV C, any T, any N and M1) Previous TransOral Robotic Surgery (TORS) to the oropharynx
2015-02-12
Study Status, Study Description v6
Study description+1,356 characters
[...] onsent form that describes the MBS procedure and its risks. You will have a video-strobe procedure to allow the doctor to look at your vocal cords. To perform a video-strobe procedure, a small camera will be inserted into the throat through your nose or mouth. You will be awake for this procedure and the study staff will give you the option of receiving a nu [...] You will fill out questionnaires about your quality of life, [...] eting these questionnaires should take about 10-15 minutes. Saliva will be collected at this visit, at the end of your treatment, and also during follow up for 2 years. You should [...] [...]
2014-12-29
2 amendments v4-v5
2 re-verifications since 2014-06-25, no change to tracked fields
2014-05-15
Study Status, Eligibility v3
Eligibility criteria+67 characters
Inclusion Criteria: Age >/= 18 Histologically documented squamous cell carcinoma of the oropharynx (Stage III-IV A,B) Tumor tissue (primary or cervical metastasis) available for human papilloma virus (HPV) /p16 (in situ hybridization (ISH) and p16, immunohistochemistry (IHC) or genotyping testing) Eastern Cooperative Oncology Group (ECOG) performance crite [...] farction within 3 months of registration. Distant Metastases (Stage IV C, any T, any N and M1)
2014-02-27
Study Identification, Study Status v2
Re-verified, no change to tracked fields
2013-08-26
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2023-11→2023-08
Start date2013-11→2013-08
Study sitesdetails revised at 1 of 1 site
2013-07-02
Original filing
This randomized phase 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.
Trial Details
NCT Number NCT01893307
Lead Sponsor M.D. Anderson Cancer Center
Collaborators: National Cancer Institute (NCI), National Institute of Dental and Craniofacial Research (NIDCR)
Conditions Stage III Oropharyngeal Squamous Cell Carcinoma AJCC v7, Stage IVA Oropharyngeal Squamous Cell Carcinoma AJCC v7, Stage IVB Oropharyngeal Squamous Cell Carcinoma AJCC v7
Enrollment 440 participants
Start Date 2013-08-26
Primary Completion 2031-12-31 (estimated)
Study Completion 2031-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-08-21