Clinical trial · Interventional
Accelerated Radiotherapy and Concomitant Chemo-radiotherapy in HNSCC
Phase III Trial Comparing Conventional RT With Concomitant CT Versus Accelerated RT With Concomitant CT Versus Very Accelerated RT Alone in Patients With Head and Neck Squamous Cell 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)
This is a multicentric randomized phase III trial comparing conventional radiotherapy with concomitant chemotherapy versus accelerated radiotherapy with concomitant chemotherapy versus very accelerated radiotherapy in patients with stage III-IV head and neck squamous cell carcinoma. The main end point is the event free survival.
Conditions
Conditions (4)
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 |
| Oral Cancer | Malignant Lip and Oral Cavity Neoplasm | CURATED_BROADER | 0.80 |
| Oropharynx Cancer | Malignant Oropharyngeal Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5FU, Paraplatin | Drug | — | UNRESOLVED |
| Conventional radiotherapy 70 Gy in 7 weeks | Procedure | — | UNRESOLVED |
| middle accelerated radiotherapy 70 Gy in 6 weeks | Procedure | — | UNRESOLVED |
| very accelerated radiotherapy 64.8 Gy in 3.5 weeks | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- 1
- interventionNames
- Procedure: Conventional radiotherapy 70 Gy in 7 weeks
- Drug: 5FU, Paraplatin
- type
- EXPERIMENTAL
- label
- 2
- interventionNames
- Procedure: middle accelerated radiotherapy 70 Gy in 6 weeks
- Drug: 5FU, Paraplatin
- type
- EXPERIMENTAL
- label
- 3
- interventionNames
- Procedure: very accelerated radiotherapy 64.8 Gy in 3.5 weeks
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Squamous cell carcinoma of oral cavity, oropharynx, hypopharynx or larynx * Stage III-IV (UICC 1997): T2, T3 or T4 with N0-N3 or T0 with N2-N3 * Not resectable * Karnofsky PS \>= 70 * Renal/liver/cardiac functions and blood counts compatible with the use of paraplatin and 5-FU * Informed consent signed Exclusion Criteria: * Distant metastasis * Contra-indication to concomitant chemotherapy * History of cancer * History of head and neck radiotherapy
References
Publications (0)
Data not yet available