Clinical trial · Interventional
Post-Operative Adjuvant Concurrent Chemoradiotherapy For High Risk Oral Cavity Squamous Cell Carcinoma Patients
Phase III Study Of Post-Operative Adjuvant Concurrent Chemoradiotherapy For High Risk Oral Cavity Squamous Cell Carcinoma Patients
- 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 this study is to confirm the value of concurrent chemoradiotherapy in improving the locoregional control and survival of patients with resected locally advanced HNSCC, a phase III randomized study is proposed. The population studied in this trial is limited to patients of oral cavity cancer; this could reduce the confounding factor of varying prognosis in patients of different primary sites of HNSCC.
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 |
|---|---|---|---|
| Oral Cavity | — | UNRESOLVED | — |
| Squamous Cell Carcinoma | Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cisplatin | Drug | Cisplatin | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- RT versus RT plus CT in effect on local control and survival of patients of oral cavity cancer after curative operation.
Secondary outcomes (1)
- measure
- the acute and chronic toxicity of RT versus RT plus CT in patients of oral cavity cancer after curative operation.
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: Clinically free of disease after having undergone surgery for histologically confirmed primary keratinizing SCC of the oral cavity. buccal mucosa upper lip (140.3) lower lip (140.4) cheek (145.0) retromolar area (145.6) bucco-alveolar sulci upper and lower (145.1) oral tongue dorsum (141.1) lateral border (141.2) inferior surface (141.3) With any one of the risk factors of recurrence listed below: Nodal extracapsular spread of disease (ECS) Number of positive node \> 2 Perineural involvement Lymphovascular emboli/permeation in resected surgical specimen Histologically positive surgical margin Exclusion Criteria: Karnofsky performance status of \<50 Concurrent or previous second primary cancer (excluding non-melanoma skin cancer) Gross residual disease following surgery Distant metastasis before or at the time of adjuvant treatment Serum creatinine \> 1.4 mg/dl, WBC \<3500/mm3, platelet \<100,000/mm3 \-
References
Publications (0)
Data not yet available