Clinical trial · Interventional
Induction CT by Cisplatin, 5FU With or Without Docetaxel in Patients With T3 and T4 Larynx and Hypopharynx Carcinoma
Randomized Study Comparing Induction Chemotherapy With Docetaxel, Cisplatin, 5FU Versus Cisplatin, 5 FU in Patients With T3 and T4 Larynx and Hypopharynx Carcinoma
- 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)
The purpose of the study is to compare two regimen of chemotherapy used as first treatment for patients with larynx or hypopharynx tumors that would be treated with total laryngectomy. The standard treatment is a combination of 2 drugs (Cisplatin and 5FU). The aim of the study is to evaluate the potential benefit of the addition of a third drug (Docetaxel) in the chemotherapy regimen. Patients will receive 3 cycles of chemotherapy. Responders to the induction treatment are treated with radiation with a purpose of larynx preservation. Non responders patients will be treated with total laryngectomy.
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 |
|---|---|---|---|
| Hypopharynx Cancer | Malignant Hypopharyngeal Neoplasm | ALIAS | 0.90 |
| Larynx Cancer | Malignant Laryngeal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (3)
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- TPF
- description
- Docetaxel, Cisplatine, 5-FU
- interventionNames
- Drug: DOCETAXEL
- Drug: Cisplatin
- Drug: 5-Fluoro-3-Pyridinecarboxylic Acid
- type
- ACTIVE_COMPARATOR
- label
- PF
- description
- Cisplatine, 5-FU
- interventionNames
- Drug: Cisplatin
- Drug: 5-Fluoro-3-Pyridinecarboxylic Acid
Primary outcomes (1)
- measure
- 3-years larynx preservation rate
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * T3 and T4 larynx and hypopharynx tumor that would be treated with total laryngectomy * Biopsy proven carcinoma * Adequate biology * Performance status 0 or 1 Exclusion Criteria: * Larynx or hypopharynx tumors that could be treated with partial laryngectomy * Distant metastasis * Prior surgery, chemotherapy or radiation * Intercurrent disease that is a contra indication to chemotherapy
References
Publications (0)
Data not yet available