Clinical trial · Interventional
Postoperative Concurrent Chemoradiation for Head and Neck Cancer With Multiple Minor Risk
A Phase II Trial of Postoperative Concurrent Chemoradiation for Head and Neck Squamous Cell Carcinoma Patients With Multiple Risk Factors of Recurrence
NCT00937612CI-TRIAL-00025862terminatedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study group showed better results. Poor Accrual.
Summary
Brief summary (as posted)
The purpose of this study is to determine the treatment outcome of postoperative concurrent chemoradiation for head and neck squamous cell carcinoma with multiple minor risks.
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 |
|---|---|---|---|
| Carcinoma, Squamous Cell | Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Head and Neck Neoplasms | Head and Neck Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- concurrent chemoradiation
- description
- patients who has 3 or more minor risk factors of recurrence, and will receive postoperative chemoradiation.
- interventionNames
- Radiation: Radiotherapy
Primary outcomes (1)
- measure
- Any kind of cancer recurrence, measured by physical examination or image study. Pathologic confirmation is recommended.
- timeFrame
- 3 year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Primary squamous cell carcinoma of head and neck, after tumor excision and neck dissection, pathology has confirmed three or more of the following adverse prognostic factors, including: 1. Marginale surgery but a safe distance from the residual tumor ≦ 4mm. 2. The tumor is located in the hard palate or the retromolar region. 3. Poorly differentiated cell type. 4. Tumor invasion to the nerve. 5. Tumor invasion to lymphatic vessels. 6. Tumor invasion to the small blood vessels. 7. Tumor invasion to the bone. 8. Tumor invasion to the skin. 9. Depth of tumor invasion ≧ 10mm. 10. Occurred in single lymph node metastasis. Exclusion Criteria: * No or presence of adverse prognostic factor but less than 2. * Presence of either one conditions listed here: positive resection margin, resection margin negative but less than 1 mm, pathologic N2 or N2, or presence of nodal metastasis with extracapsular spreading. * ECOG performance status \> 2. * Previous cancer history (except basal cell or squamous cell skin cancer) or other synchronous malignant disease. * Women during pregnancy.
References
Publications (0)
Data not yet available
No reference posted for this study.