Clinical trial · Interventional
Chemotherapy and Radiation Therapy With or Without Surgery in Treating Patients With Head and Neck Cancer
A Phase III Trial of Concurrent Radiation and Chemotherapy for Advanced Head and Neck Carcinomas
NCT00047008CI-TRIAL-00067866completedPhase 3Results postedClinicalTrials.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 (RT) uses high-energy x-rays to damage tumor cells. Giving radiation therapy in different ways and combining it with chemotherapy before surgery may kill more tumor cells. It is not yet known which radiation therapy regimen combined with chemotherapy with or without surgery is more effective for head and neck cancer. PURPOSE: Randomized phase III trial to compare two different radiation therapy regimens combined with cisplatin with or without surgery in treating patients who have stage III or stage IV head and neck cancer.
Conditions
Conditions (1)
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 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Accelerated fractionation radiation therapy | Radiation | — | UNRESOLVED |
| cisplatin | Drug | Cisplatin | ALIAS |
| Conventional surgery for select patients | Procedure | — | UNRESOLVED |
| Standard fractionation RT | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- Standard fractionation RT + cisplatin
- description
- Standard fractionation radiation therapy with concurrent cisplatin followed by conventional surgery for select patients.
- interventionNames
- Drug: cisplatin
- Radiation: Standard fractionation RT
- Procedure: Conventional surgery for select patients
- type
- EXPERIMENTAL
- label
- Accelerated fractionation RT + cisplatin
- description
- Accelerated fractionation radiation therapy by concomitant boost with concurrent cisplatin followed by conventional surgery for select patients.
- interventionNames
- Drug: cisplatin
- Radiation: Accelerated fractionation radiation therapy
- Procedure: Conventional surgery for select patients
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx * Stage III or IV (T2, N2-3, M0 or T3-4, any N, M0) * No metastases below the clavicle or more distant by clinical exam or radiology PATIENT CHARACTERISTICS: Age * 18 and over Performance status * Zubrod 0-1 Life expectancy * Not specified Hematopoietic * Absolute granulocyte count at least 2,000/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic * Bilirubin no greater than 1.5 mg/dL * Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) no greater than 2 times upper limit of normal Renal * Creatinine no greater than 1.5 mg/dL * Creatinine clearance at least 50 mL/min * Calcium normal Cardiovascular * No symptomatic coronary artery disease (angina) * No myocardial infarction within the past 6 months Other * No other invasive malignancy within the past 3 years except nonmelanoma skin cancer * No simultaneous primary tumors * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * No prior chemotherapy Endocrine therapy * Not specified Radiotherapy * No prior radiotherapy to the head and neck except radioactive iodine therapy Surgery * No prior surgery to the primary tumor or nodes except diagnostic biopsy or nodal sampling of neck disease * No radical or modified neck dissection
References
Publications (11)
- BACKGROUNDGillison ML, Zhang Q, Jordan R, Xiao W, Westra WH, Trotti A, Spencer S, Harris J, Chung CH, Ang KK. Tobacco smoking and increased risk of death and progression for patients with p16-positive and p16-negative oropharyngeal cancer. J Clin Oncol. 2012 Jun 10;30(17):2102-11. doi: 10.1200/JCO.2011.38.4099. Epub 2012 May 7. PMID 22565003
- RESULTWuthrick EJ, Zhang Q, Machtay M, et al.: The influence of institutional head and neck cancer (HNC) clinical trial accrual on overall survival (OS): An analysis of RTOG 0129. [Abstract] J Clin Oncol 30 (Suppl 15): A-5530, 2012.
- RESULTAng KK, Harris J, Wheeler R, Weber R, Rosenthal DI, Nguyen-Tan PF, Westra WH, Chung CH, Jordan RC, Lu C, Kim H, Axelrod R, Silverman CC, Redmond KP, Gillison ML. Human papillomavirus and survival of patients with oropharyngeal cancer. N Engl J Med. 2010 Jul 1;363(1):24-35. doi: 10.1056/NEJMoa0912217. Epub 2010 Jun 7. PMID 20530316
- RESULTAng K, Zhang Q, Wheeler RH, et al.: A phase III trial (RTOG 0129) of two radiation-cisplatin regimens for head and neck carcinomas (HNC): impact of radiation and cisplatin intensity on outcome. [Abstract] J Clin Oncol 28 (Suppl 15): A-5507, 2010.
- RESULTGillison ML, Harris J, Westra W, et al.: Survival outcomes by tumor human papillomavirus (HPV) status in stage III-IV oropharyngeal cancer (OPC) in RTOG 0129. [Abstract] J Clin Oncol 27 (Suppl 15): A-6003, 2009.
- RESULTAng K, Pajak T, Rosenthal DI, et al.: A phase III trial to compare standard versus accelerated fractionation in combination with concurrent cisplatin for head and neck carcinomas (RTOG 0129): report of compliance and toxicity. [Abstract] Int J Radiat Oncol Biol Phys 69 (3 Suppl): A-21, S12-13, 2007.
- DERIVEDGharzai LA, Morris E, Schipper MJ, Kidwell KM, Nguyen-Tan PF, Rosenthal DI, Gillison ML, Jordan RC, Garden AS, Koyfman SA, Caudell JJ, Blakaj DM, Dunlap NE, Krempl GA, Longo JM, Jones CU, Gensheimer MF, Galloway TJ, DeMora L, Le QT, Shah JL, Suresh K, Mierzwa M. Treatment Interruption and Outcomes in Head and Neck Cancer: A Secondary Analysis of 3 Randomized Clinical Trials. JAMA Otolaryngol Head Neck Surg. 2026 Feb 1;152(2):144-153. doi: 10.1001/jamaoto.2025.4203.