Clinical trial · Interventional
Intensity-Modulated Proton Beam Therapy or Intensity-Modulated Photon Therapy in Treating Patients With Stage III-IVB Oropharyngeal Cancer
Phase 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
NCT01893307CI-TRIAL-00123223active not recruitingPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Stage III Oropharyngeal Squamous Cell Carcinoma AJCC v7 | Oropharyngeal Squamous Cell Carcinoma | CURATED_BROADER | 0.78 |
| Stage IVA Oropharyngeal Squamous Cell Carcinoma AJCC v7 | Oropharyngeal Squamous Cell Carcinoma | CURATED_BROADER | 0.78 |
| Stage IVB Oropharyngeal Squamous Cell Carcinoma AJCC v7 | Oropharyngeal Squamous Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Intensity-Modulated Radiation Therapy | Radiation | — | UNRESOLVED |
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
| Photon Beam Radiation Therapy | Radiation | — | UNRESOLVED |
| Proton Beam Radiation Therapy | Radiation | — | UNRESOLVED |
| Quality-of-Life Assessment | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I (IMRT)
- description
- Patients undergo IMRT QD five days a week for approximately 6.5 weeks.
- interventionNames
- Radiation: Intensity-Modulated Radiation Therapy
- Other: Laboratory Biomarker Analysis
- Radiation: Photon Beam Radiation Therapy
- Other: Quality-of-Life Assessment
- type
- EXPERIMENTAL
- label
- Arm II (IMPT)
- description
- Patients undergo IMPT QD five days a week for approximately 6.5 weeks.
- interventionNames
- Radiation: Intensity-Modulated Radiation Therapy
- Other: Laboratory Biomarker Analysis
- Radiation: Proton Beam Radiation Therapy
- Other: Quality-of-Life Assessment
Primary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically documented squamous cell carcinoma of the oropharynx (American Joint Committee on Cancer \[AJCC\] version \[v\]7 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: * Symptomatic congestive heart failure, unstable angina, or cardiac dysrhythmia not controlled by pacer device * 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
References
Publications (3)
- DERIVEDFrank SJ, Busse PM, Lee JJ, Rosenthal DI, Hernandez M, Swanson DM, Garden AS, Gunn GB, Patel SH, Snider JW, Ma DJ, Molitoris JK, Lee NY, Parvathaneni U, McDonald MW, Kalman NS, Lin A, Mohammed N, Henson C, Hyde C, Bajaj GK, Katz SR, Dagan R, Morrison WH, Reddy JP, Fuller CD, Shah SJ, Phan J, Chronowski GM, Mayo L, Sturgis EM, Ferrarotto R, Zhu XR, Zhang X, Wang L, Hutcheson KA, El-Naggar AK, Moreno AC, Lee A, Spiotto MT, Gross ND, Lai SY, Liao JJ, Paly J, Liao Z, Foote RL; University of Texas MD Anderson Cancer Center Clinical Trial Consortium. Proton versus photon radiotherapy for patients with oropharyngeal cancer in the USA: a multicentre, randomised, open-label, non-inferiority phase 3 trial. Lancet. 2026 Jan 10;407(10524):174-184. doi: 10.1016/S0140-6736(25)01962-2. Epub 2025 Dec 11. PMID 41391462
- DERIVEDMoreno A, Sahli AJ, Johnson F, Sun X, Barbon C, Rinsurongkawong W, Song W, Luciani FM, Liang H, Li J, Liu W, Lee JJ, Frank SJ, Lai S, Fuller C, Hutcheson K; P01 MD Anderson Oropharynx Cancer Program. Stiefel MD Anderson OroPharynx cancer (MDA-OPC) cohort: a single-institution, prospective longitudinal outcomes study. BMJ Open. 2025 Nov 24;15(11):e106845. doi: 10.1136/bmjopen-2025-106845. PMID 41290309
- DERIVEDGunn GB, Blanchard P, Garden AS, Zhu XR, Fuller CD, Mohamed AS, Morrison WH, Phan J, Beadle BM, Skinner HD, Sturgis EM, Kies MS, Hutcheson KA, Rosenthal DI, Mohan R, Gillin MT, Frank SJ. Clinical Outcomes and Patterns of Disease Recurrence After Intensity Modulated Proton Therapy for Oropharyngeal Squamous Carcinoma. Int J Radiat Oncol Biol Phys. 2016 May 1;95(1):360-367. doi: 10.1016/j.ijrobp.2016.02.021. Epub 2016 Feb 12. PMID 27084653