Clinical trial · Interventional
Radiation Therapy in Treating Patients With Stage II or Stage III Oropharyngeal Cancer
Conformal and Intensity Modulated Irradiation for Oropharyngeal Cancer
NCT00006360CI-TRIAL-00047849completedPhase 1 / Phase 2ClinicalTrials.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)
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of radiation therapy in treating patients who have stage II or stage III oropharyngeal cancer.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Radiation Toxicity | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| radiation therapy | Radiation | — | UNRESOLVED |
| radioprotection | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (4)
- measure
- Acute salivary gland toxicity
- measure
- Locoregional control
- measure
- Whole mouth saliva output relative to pre-radiotherapy measurements
- measure
- Acute mucositis and other acute and late toxicities
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically proven stage II or III (T1-T2, N0-N1) squamous cell carcinoma of the oropharynx (tonsil, base of tongue, or palate) * Lymph nodes in both sides of neck at risk of metastatic disease and require radiotherapy * Patients upstaged by imaging to N2 are eligible * Measurable or evaluable disease * Greater than 1 cm in one dimension or with necrotic regions if by CT or MRI scan * Surgery of the primary tumor or lymph nodes limited to incisional or excisional biopsies * No distant metastases PATIENT CHARACTERISTICS: Age: * Over 18 Performance status: * Zubrod 0-1 Life expectancy: * Not specified Hematopoietic: * Not specified Hepatic: * Not specified Renal: * Not specified Other: * No active untreated infection * No other malignancy within the past 5 years except nonmelanoma skin cancer or a carcinoma not of head or neck origin * No concurrent major medical or psychiatric illness that would preclude study PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * More than 3 months since prior chemotherapy * No concurrent chemotherapy Endocrine therapy: * Not specified Radiotherapy: * No prior head or neck radiotherapy Surgery: * See Disease Characteristics Other: * No other concurrent treatment for head and neck cancer * No prophylactic amifostine or pilocarpine
References
Publications (4)
- BACKGROUNDPloquin N, Lau H, Dunscombe P. Intensity modulated and three-dimensional conformal radiation therapy plans for oropharyngeal cancer: a comparison of their sensitivity to set-up errors and uncertainties. Curr Oncol. 2006 Apr;13(2):61-6. doi: 10.3390/curroncol13020005. PMID 17576443
- RESULTEisbruch A, Harris J, Garden AS, Chao CK, Straube W, Harari PM, Sanguineti G, Jones CU, Bosch WR, Ang KK. Multi-institutional trial of accelerated hypofractionated intensity-modulated radiation therapy for early-stage oropharyngeal cancer (RTOG 00-22). Int J Radiat Oncol Biol Phys. 2010 Apr;76(5):1333-8. doi: 10.1016/j.ijrobp.2009.04.011. Epub 2009 Jun 18. PMID 19540060
- RESULTEisbruch A, Harris J, Garden A, et al.: Phase II multi-institutional study of IMRT for oropharyngeal cancer (RTOG 00-22): early results. [Abstract] Int J Radiat Oncol Biol Phys 66 (3 Suppl 1): A-79, S46-7, 2006.
- DERIVEDGarden AS, Harris J, Eisbruch A, Chao KSC, Morrison WH, Harari PM, Swanson TA, Jones CU, Yom SS, Spencer SA, Scrimger R, Shenouda G, Shukla M, Lau HY, Mierzwa M, Torres-Saavedra P, Le QT. Final Report of NRG Oncology RTOG 0022: A Phase 1/2 Study of Conformal and Intensity Modulated Radiation for Oropharyngeal Cancer. Int J Radiat Oncol Biol Phys. 2023 Oct 1;117(2):333-340. doi: 10.1016/j.ijrobp.2023.02.057. Epub 2023 Mar 15. No abstract available. PMID 36925074