A study on carcinoma of oral cavity undergoing surgery and then treated with radiation therapy with lesser number of treatment fractions

Prospective Evaluation of Acute Toxicity and Loco Regional Control in Post-Operative Oral Cavity Squamous Cell Carcinoma Treated with Moderately Hypofractionated Intensity Modulated Radiation Therapy - AVIATOR

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/02/049519

Enrollment

Registered

2023-02-07

Start date

Unknown

Completion date

Unknown

Last updated

2023-03-06

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

Conditions

Health Condition 1: C060- Malignant neoplasm of cheek mucosa Health Condition 2: C049- Malignant neoplasm of floor of mouth, unspecified Health Condition 3: C039- Malignant neoplasm of gum, unspecified Health Condition 4: C029- Malignant neoplasm of tongue, unspecified

Interventions

Intervention1: Hypofractionated Intensity modulated radiotherapy: Duration of the study: 18 months Patients of oral cavity squamous cell carcinoma undergoing definitive surgery would receive adjuvant

Eligibility

Inclusion criteria

Inclusion criteria: 1. Post-operative patients (age 18-80 years) of oral cavity squamous cell carcinoma (excluding lip). 2. Karnofsky performance status 70 or above 3. One or more of the following risk factors: pT3/pT4, Node positive, Close margin (1-5mm), Perineural invasion present, Lympho-vascular invasion present, depth of invasion >= 4mm for tongue and >=7 mm for buccal mucosa 4. Patients with indications for chemo-radiation but who are 5. unfit for chemotherapy due to associated comorbid conditions or poor GC 6. unwilling to undergo chemotherapy

Exclusion criteria

Exclusion criteria: 1. Patients with absolute indications for concurrent chemo-radiotherapy (margin positive disease, extra-capsular extension) 2. Patients who have received neoadjuvant chemotherapy. 3. Any histopathology other than SCC 4. Previous radiotherapy to the head and neck region 5. Patients with absolute indications for concurrent chemoradiotherapy. 6. Synchronous or metachronous malignancy 7. Pregnant or lactating women 8. Uncontrolled concurrent illness like DM, HTN

Design outcomes

Primary

Measure	Time frame
To assess the acute toxicity in the patients of post-operative oral cavity Squamous Cell Carcinoma (OCSCC) treated with Hypo-fractionated intensity modulated radiotherapy. Timepoint: During radiotherapy, acute toxicity will be assessed at every week (Week 1- Week 5), then every 2 weekly for 2 months and then at 3 months after completion of radiotherapy	—

Secondary

Measure	Time frame
To evaluate the efficacy in terms of loco-regional control (LRC) and late toxicity in the patients of post-operative oral cavity Squamous Cell Carcinoma (OCSCC) treated with Hypo-fractionated intensity modulated radiotherapy. Timepoint: Late toxicity will be evaluated starting from 3 months after completion of radiotherapy and will be assessed at 3 months, 6 months, 12 months, 18 months and 24 months from the date of completion of radiotherapy Loco-regional control will be assessed at 18 months and 24 months after completion of radiotherapy	—

Measure

Time frame

To evaluate the efficacy in terms of loco-regional control (LRC) and late toxicity in the patients of post-operative oral cavity Squamous Cell Carcinoma (OCSCC) treated with Hypo-fractionated intensity modulated radiotherapy. Timepoint: Late toxicity will be evaluated starting from 3 months after completion of radiotherapy and will be assessed at 3 months, 6 months, 12 months, 18 months and 24 months from the date of completion of radiotherapy Loco-regional control will be assessed at 18 months and 24 months after completion of radiotherapy

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Countries

India

Contacts

Public ContactDr Pankaj Yadav

Dr RMLIMS

ajeetgandhi23@gmail.com8176007283

Outcome results

None listed

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