Clinical trial · Interventional
Cisplatin Plus Raltitrexed or 5-fluorouracil Concurrent With Radiotherapy for Head and Neck Squamous Cell Cancer
A Multicenter Phase Ⅲ Trial of Cisplatin Plus Raltitrexed or 5-fluorouracil in Concurrence With Intensity-modulated Radiotherapy (IMRT) for the Treatment of Locoregionally Advanced Head and Neck Squamous Cell Cancer
NCT02485548CI-TRIAL-00018400unknownPhase 3ClinicalTrials.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 study is a multicenter phase Ⅲ trial. The objective is to compare the efficacy and toxicity of cisplatin plus raltitrexed or 5-fluorouracil in concurrence with IMRT for patients with locoregionally advanced head and neck squamous cell 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 Squamous Cell Cancer | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5-fluorouracil | Drug | Fluorouracil | ALIAS |
| Cisplatin | Drug | Cisplatin | ALIAS |
| IMRT | Radiation | — | UNRESOLVED |
| Raltitrexed | Drug | Raltitrexed | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Raltitrexed plus cisplatin
- description
- Raltitrexed plus cisplatin and IMRT
- interventionNames
- Drug: Raltitrexed
- Drug: Cisplatin
- Radiation: IMRT
- type
- ACTIVE_COMPARATOR
- label
- 5-fluorouracil plus cisplatin
- description
- 5-fluorouracil plus cisplatin and IMRT
- interventionNames
- Drug: 5-fluorouracil
- Drug: Cisplatin
- Radiation: IMRT
Primary outcomes (1)
- measure
- Progression-free survival (PFS)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Pathologically confirmed untreated head and neck squamous cell cancer patients * 18-70 years * Clinical stage: T3-4N0-3M0 or T1-4N1-3M0 * Hematologic function: WBC ≥ 4.0×109/L, PLT ≥ 80×109/L, Hb ≥ 10mg/dL * Renal function: Cr ≤ 1.25×UNL * Hepatic function: BIL ≤ 1.5×UNL, ALT/AST ≤ 2.5×UNL * ECOG ≤ 1 * Woman and man of childbearing age must adopt contraception * With written consent Exclusion Criteria: * Malignant history * Pregnant or lactating women * With other severe diseases (blood, liver ,kidney or heart diseases) * Subjects not suitable for chemo-radiotherapy * Without written consent
References
Publications (0)
Data not yet available
No reference posted for this study.