Clinical trial · Interventional
Chemotherapy Plus Radiation Therapy in Treating Patients With Head and Neck Cancer
Hyperfractionated Radiotherapy With Concomitant Fluorouracil and Hydroxurea for Intermediate Stage Cancer of the Head and Neck
NCT00002951CI-TRIAL-00011990completedPhase 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: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining radiation therapy with chemotherapy may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of chemotherapy plus radiation therapy in treating patients with head and neck 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 |
|---|---|---|---|
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| fluorouracil | Drug | Fluorouracil | ALIAS |
| hydroxyurea | Drug | Hydroxyurea | ALIAS |
| radiation therapy | Radiation | — | UNRESOLVED |
| surgical procedure | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm A (Hyper-FHX)
- description
- Concomitant chemoradiotherapy consisting of hydroxyurea (PO, BID, x 6days), continuous infusion 5-fluorouracil (IV, x 5days), hyperfractionated radiotherapy (150 cGy twice daily for 5 days every 14 days, 5 cycles)
- interventionNames
- Drug: fluorouracil
- Drug: hydroxyurea
- Procedure: surgical procedure
- Radiation: radiation therapy
Primary outcomes (1)
- measure
- Locoregional control rate
- timeFrame
- 8 years
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed diagnosis of carcinoma * Stage II-III (T2, T3, N0 or T1-3, N1) carcinoma of head and neck, including: oral cavity, pharynx, larynx, paranasal sinuses, and cervical esophagus * No N2 or N3 * Measurable disease is not required PATIENT CHARACTERISTICS: Age: * Not specified Performance status: * Zubrod 0-3 Life expectancy: * Anticipated survival is 3-4 years (median) Hematopoietic: * WBC count at least 3.5/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * Not specified Renal: * Not specified Cardiovascular: * Not specified Pulmonary: * Not specified Other: * No infection or severe medical illness * Not pregnant PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * No prior chemotherapy Endocrine therapy: * Not specified Radiotherapy: * No prior radiotherapy Surgery: * No prior surgery
References
Publications (1)
- RESULTCohen EE, Haraf DJ, List MA, Kocherginsky M, Mittal BB, Rosen F, Brockstein B, Williams R, Witt ME, Stenson KM, Kies MS, Vokes EE. High survival and organ function rates after primary chemoradiotherapy for intermediate-stage squamous cell carcinoma of the head and neck treated in a multicenter phase II trial. J Clin Oncol. 2006 Jul 20;24(21):3438-44. doi: 10.1200/JCO.2006.05.8529. PMID 16849759