Clinical trial · Interventional
IMRT Plus Cisplatin Versus Conventional Radiotherapy Plus Cisplatin in Stage III-IV HNSCC
Phase III Trial of Intensity-modulated Radiotherapy Plus Cisplatin Versus Conventional Radiotherapy Plus Cisplatin in Patients With Stage III-IV 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 intensity-modulated radiotherapy (75 Gy) plus cisplatin versus conventional radiotherapy (70 Gy) plus cisplatin in patients with stage III-IV squamous cell carcinoma of oral cavity, oropharynx or hypopharynx. The main end points are the rate of locoregional control and the rate of xerostomia at 2 years.
Conditions
Conditions (3)
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 |
| Oral Cancer | Malignant Lip and Oral Cavity Neoplasm | CURATED_BROADER | 0.80 |
| Oropharynx Cancer | Malignant Oropharyngeal Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| concomitant cisplatin | Drug | — | UNRESOLVED |
| Conventional radiotherapy 70 Gy | Procedure | — | UNRESOLVED |
| IMRT 75 Gy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- 1
- description
- Conventional RT 70Gy + concomitant cisplatin
- interventionNames
- Procedure: Conventional radiotherapy 70 Gy
- Drug: concomitant cisplatin
- type
- EXPERIMENTAL
- label
- 2
- description
- IMRT 75Gy + concomitant cisplatin
- interventionNames
- Procedure: IMRT 75 Gy
- Drug: concomitant cisplatin
Primary outcomes (1)
- measure
- Loco regional control
- timeFrame
- 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * squamous cell carcinoma of oral cavity, oropharynx or hypopharynx * Stage III - IV (T1-T4, N0-N2)(UICC 2002) * Not resected * Indication of radiotherapy to bilateral cervical nodes at dose\>= 50 Gy * Delineation of target volumes done before randomization * Scintigraphy of parotid gland done before radiotherapy start * Quality of life questionnaires (EORTC-C30 and EORTC-H\&N35) filled in by the patient * Informed consent signed Exclusion Criteria: * N3 (UICC 2002) * Distant metastasis * Contra-indication to concomitant cisplatin * History of cancer within the last 5 years * History of head and neck radiotherapy * Administration of drugs for treatment or prophylaxis of xerostomia (pilocarpine, ethyol)
References
Publications (1)
- DERIVEDTao Y, Auperin A, Blanchard P, Alfonsi M, Sun XS, Rives M, Pointreau Y, Castelli J, Graff P, Wong Hee Kam S, Thariat J, Veresezan O, Heymann S, Renard-Oldrini S, Lafond C, Cornely A, Casiraghi O, Boisselier P, Lapeyre M, Biau J, Bourhis J. Concurrent cisplatin and dose escalation with intensity-modulated radiotherapy (IMRT) versus conventional radiotherapy for locally advanced head and neck squamous cell carcinomas (HNSCC): GORTEC 2004-01 randomized phase III trial. Radiother Oncol. 2020 Sep;150:18-25. doi: 10.1016/j.radonc.2020.05.021. Epub 2020 May 15. PMID 32417348