Clinical trial · Interventional
Concomitant Chemoradiotherapy (CCRT) With Weekly Docetaxel and Cisplatin for Locally Advanced Head and Neck Cancer
A Phase II Trial of Concurrent Chemoradiotherapy With Weekly Docetaxel and Cisplatin for Locally Advanced Head and Neck Cancer
NCT01126008CI-TRIAL-00050807completedPhase 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)
This phase II trial is evaluating the efficacy of concurrent chemoradiation therapy with weekly docetaxel and cisplatin combination regimen.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CCRT with weekly docetaxel & cisplatin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- weekly docetaxel and cisplatin
- interventionNames
- Drug: CCRT with weekly docetaxel & cisplatin
Primary outcomes (1)
- measure
- Complete response rate
- timeFrame
- 3-4 weeks after completion of CCRT
Secondary outcomes (3)
- measure
- quality of life
- timeFrame
- Pretreatment & 3-4 weeks after completion of treatment
- measure
- overall survival rate
- timeFrame
- 2 year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histologically confirmed squamous cell carcinoma of the head and neck (SCCHN) of one of following sites : oral cavity, oropharynx, larynx, or hypopharynx 2. Unresectable Stage III - ⅣB disease 3. previously untreated for head \& Neck cancer with chemotherapy or radiotherapy 4. 18 and over 5. Performance status ECOG 0-1 6. Absolute neutrophil count ≥ 1,500/mm3 7. Platelet count ≥ 75,000/mm3 8. Hemoglobin \> 9.0 g/dL 9. Bilirubin ≤ 1.5 times upper limit of normal (ULN) 10. AST or ALT, and alkaline phosphatase meeting 1 of the following parameters:Alkaline phosphatase ≤ 1.5 times ULN AND AST or ALT ≤ 5 times ULN Alkaline phosphatase ≤ 2.5 times ULN AND AST or ALT ≤ 1.5 times ULN Alkaline phosphatase ≤ 5 times ULN AND AST or ALT ≤ ULN 11. serum creatinine ≤ 1.5 mg/dl or creatinine clearance ≥ 60 ml/min Exclusion Criteria: 1. Distant metastatic disease (M1) 2. Prior chemotherapy or RT for Head and neck cancer 3. Synchronous or concurrent head and neck primary tumors 4. Lip, nasopharynx, nasal cavity, salivary gland, or sinuses 5. No other invasive malignancy within the past 3 years except nonmelanoma skin cancer or papillary thyroid cancer 6. Other concurrent illness that would preclude study participation 7. Other concurrent physical condition (e.g., infectious disease) that would preclude study participation 8. pregnant or nursing 9. Fertile patients must use effective contraception during and for 3 months after study participation
References
Publications (0)
Data not yet available
No reference posted for this study.