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Chemoradiotherapy versus Radiotherapy alone in post-operative locally advanced oral cavity cancer

Adjuvant radiotherapy with or without concurrent chemotherapy in oral cavity cancer with multiple pathological minor risk factors - NIL

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/06/069157
Enrollment
100
Registered
2024-06-19
Start date
Unknown
Completion date
Unknown
Last updated
2024-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C00-C14- Malignant neoplasms of lip, oral cavity and pharynx

Interventions

Intervention1: Concurrent chemotherapy: Concurrent chemotherapy in the form of cisplatin at 40mg/sq.m weekly to total of 6 cycles along with radiotherapy 60Gy in 30fractions for 6 weeks for postoperat

Sponsors

Department Of Radiotherapy and Radiation medicine
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Histologically proven postoperative oral cavity carcinoma, squamous-cell carcinoma histology, three or more minor risk factors (include T4/T3 disease, multiple lymphnodes, a surgical margin =5 mm, moderate and poor differentiation, perineural invasion, vessel invasion, lymphovascular invasion, and tumor invasion depth = 10mm, age of 18 to 70 years of either sex, ECOG of 0 -1, adequate hematologic, renal, and hepatic function, adequate Creatinine clearance

Exclusion criteria

Exclusion criteria: Presence of positive resection margins, extra capsular spreading in metastatic nodes, history of previous cancer, second synchronous malignancy, any contraindication for concurrent chemotherapy and radiotherapy.

Design outcomes

Primary

MeasureTime frame
Loco-regional control at 3 months of treatmentTimepoint: 3 months

Secondary

MeasureTime frame
Acute toxicity, overall Survival, disease free survival, late toxicity (after 3 months of completion of treatment) Timepoint: 3 months

Countries

India

Contacts

Public ContactDr Himanshu Mishra

Institute of Medical science, Banarus Hindu University

hmsra1801@gmail.com7704909900

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026