Clinical trial · Interventional
Adjuvant ChemoRadiotherapy Prior to Surgery in Stage IVa Oral Cancers
Assessing Efficacy of Neoadjuvant Chemoradiotherapy as a Treatment Plan for Patients With Stage IVa Oral Cancer.
- 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)
Oral cancer is the single largest cancer in males in India. 90-95% cases of oral cancer are Squamous cell carcinomas and many of them present at late stages (T3 and above). Treatment of OSCC includes single modality surgery, radiotherapy, or combinations of these modalities with or without systemic therapy. For unresectable cases, radiotherapy and/or chemotherapy is the treatment modality. Efficacy of neoadjuvant chemoradiotherapy for resectable stage IV tumors (late stage) needs to be evaluated to assess its benefit before surgery.
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 of Oral Cavity | Oral Cavity Squamous Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Neoadjuvant chemotherapy | Drug | — | UNRESOLVED |
| Neoadjuvant radiotherapy | Radiation | — | UNRESOLVED |
| Resection and reconstruction | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Neoadjuvant chemoradiotherapy followed by surgery
- description
- Preoperative chemotherapy with concurrent radiotherapy followed by definitive surgery
- interventionNames
- Drug: Neoadjuvant chemotherapy
- Radiation: Neoadjuvant radiotherapy
- Procedure: Resection and reconstruction
Primary outcomes (3)
- measure
- Objective response rate
- timeFrame
- Upto 1 year
- description
- This will be deduced from pathological response in terms of complete and partial response. Complete response is defined as no invasive and no in situ residuals present in the surgical specimen. Partial response defined as at least a 30% reduction in the size of the lesion in the surgical specimen.
- measure
- Disease free survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histologically confirmed stage IVa squamous cell carcinoma of the oral cavity. 2. Surgically resectable oral squamous carcinoma with invasion of mandible or maxilla. 3. Newly diagnosed or previously untreated squamous cell carcinoma of the oral cavity. Exclusion Criteria: 1. Patients with distant metastases. 2. Patients with contraindication to radiotherapy. 3. Patients with vascular disorders or ischemic heart disease. -
References
Publications (0)
Data not yet available