Clinical trial · Interventional
CETUXIMAB Given for 3 Weeks as Neoadjuvant Treatment in Locally Advanced Tongue Cancer ; A NEW PARADIGM OF TREATMENT
CETUXIMAB Given for 3 Weeks as Neoadjuvant Treatment Followed by 6 Weeks of Cetuximab+RT Post Surgery in Locally Advanced Squamous Cell Carcinoma of the Tongue ; A NEW PARADIGM OF TREATMENT
- 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)
To compare the Disease free survival (DFS) rate of a preoperative cetuximab treatment followed by operation and postoperative radiation-cisplatin-cetuximab treatment paradigm for advanced oral cavity cancer, , with the DFS rate of historical controls (from the RTOG 9501 and EORTC 22931 studies in which treatment was with surgery followed by radiotherapy and cisplatin) with a similar stage of the disease.
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 |
|---|---|---|---|
| Squamous Cell Carcinoma | Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Erbitux,merck serono | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Cetuximab ,neoadjuvant administration
- description
- Drug administration ,Cetuximab(merck Serono )given neoadjuvant ,3 courses prior surgery followed by post operatve radiation and Cetuximab
- interventionNames
- Drug: Erbitux,merck serono
Primary outcomes (1)
- measure
- PROGRESSION FREE SURVIVAL
- timeFrame
- 2 YEARS
- description
- : To compare the Disease free survival (DFS) rate of a preoperative cetuximab treatment followed by operation and postoperative radiation-cisplatin-cetuximab treatment paradigm for advanced oral cavity cancer, , with the DFS rate of historical controls (from the RTOG 9501 and EORTC 22931 studies in which treatment was with surgery followed by radiotherapy and cisplatin) with a similar stage of the disease
Secondary outcomes (2)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: Pathologically confirmed, previously untreated, resectable squamous cell carcinoma of the tongue at disease stage III or IV; Age ≥18 to ≤80; Eastern Cooperative Oncology Group (ECOG) Performance status 0-1;willingto give written informed consent for participation in this study - Exclusion Criteria: Any prior head and neck malignancy or other malignancy in the last 5 years but BCC; Prior head and neck radiation; Documented evidence of distant metastases; Pregnancy or lactation; Clinically significant cardiovascular disease; Known hypersensitivity to any of the components of the treatment; Legal incapacity; Clinically relevant neuropathy; Any medical or psychiatric illness which would compromise the patient's ability to tolerate this treatment, or interfere with the study objectives. -
References
Publications (0)
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