Skip to content

Role of Adjuvant Therapy in Early-Stage Oral Cavity Squamous Cell Carcinoma: An Ambispective Analysis

Trial to observe the risk factors and role of radiotherapy in early-stage oral cancer patients who have undergone curative surgery

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2023/10/058775
Enrollment
196
Registered
2023-10-18
Start date
Unknown
Completion date
Unknown
Last updated
2023-11-13

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

Conditions

Health Condition 1: C021- Malignant neoplasm of border of tongue

Interventions

Intervention1: NIL: NIL

Sponsors

All India Institute of Medical Sciences, New Dehi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All HPE prove squamous cell carcinoma of oral cavity (Stage I and II) who underwent surgery of primary and neck dissection

Exclusion criteria

Exclusion criteria: Non-squamous histology 2. Advanced stages (pT3, pT4a or pT4b) 3. Positive tumor margins Page | 20 4. Any nodal metastasis 5. Any distant metastasis 6. History of any previous malignancy in the past 5 years 7. History of any therapeutic irradiation to the head and neck region 8. Patients with Poor Performance Status (of 3 or more)

Design outcomes

Primary

MeasureTime frame
Primary Objective a.To determine the impact of adjuvant radiation therapy on locoregional recurrence in patients of early stage (T1-2, N0) OSCC with adverse features. 2)Secondary Objective a.To compare Overall Survival & Disease-Free Survival between the two groups. b.To compare the quality of life between the two groups. c.To assess radiation-induced toxicity (both short & long-term). Timepoint: 6 weeks

Secondary

MeasureTime frame
2) Secondary Objective a. To compare Overall Survival & Disease-Free Survival between the two groups. b. To compare the quality of life between the two groups. c. To assess radiation-induced toxicity (both short & long-term). Timepoint: 6 weeks

Countries

India

Contacts

Public ContactRachit Sood

All India Institute of Medical Sciences, New Delhi

amitchirom@gmail.com9999501928

Outcome results

None listed

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