Study to evaluate acute toxicity in postoperative head and neck cancer patients undergoing radiotherapy

Prospective trial to evaluate acute toxicity during post operative radiotherapy after flap reconstructive surgery in head and neck cancer patients undergoing volumetric modulated ARC therapy

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/08/093784

Enrollment

Registered

2025-08-27

Start date

Unknown

Completion date

Unknown

Last updated

2025-09-15

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

Conditions

Health Condition 1: C01- Malignant neoplasm of base of tongue Health Condition 2: C04- Malignant neoplasm of floor of mouth Health Condition 3: C03- Malignant neoplasm of gum Health Condition 4: C00- Malignant neoplasm of lip Health Condition 5: C00-C14- Malignant neoplasms of lip, oral cavity and pharynx

Interventions

Intervention1: INTERVENTION GROUP: Study group will receive Postoperative Radiotherapy to surgical flap using two dose prescription volume PTV60Gy and PTV54Gy. Control Intervention1: CONTROL GROUP: Co

Eligibility

Inclusion criteria

Inclusion criteria: 1.Biopsy proven Squamous cell carcinoma of oral cavity and paranasal sinus. 2.Adult patients undergoing surgery with flap reconstruction and post operative radiotherapy. 3.Patients requiring post operative radiotherapy for any of the following indications: T3N0M0, T1-3N1,2M0, T4aN2M0, AnyTN3M0 disease. 4.Patient requiring postoperative radiotherapy due to positive margin, close margin, extra nodal extension in Post Operative Histopathology Report. Patients giving written consent for study and follow up

Exclusion criteria

Exclusion criteria: 1.Patient being treated for recurrent head and neck cancer. 2.Patient with uncontrolled comorbidities like diabetes mellitus and hypertension. 3.Previous history of undergoing head and neck radiotherapy.

Design outcomes

Primary

Measure	Time frame
1.To evaluate acute toxicity (mucositis, dysphagia, dermatitis, xerostomia, dysgeusia, anorexia, nausea, vomiting, pain) of postoperative radiotherapy between SIB- VMAT and non SIB- VMAT treatment technique during treatment and at 3 months follow up. Timepoint: 1.During treatment 2. At 3 months follow up.	—

Secondary

Measure	Time frame
To evaluate incidence of flap complications- infection, mild dehiscence, bone exposure, fistula, hematoma, partial flap loss, complete flap loss)between SIB- VMAT and non SIB- VMAT treatment technique during treatment and at 3 months follow up. 2. To evaluate disease recurrence between the study groups at a minimum of three months follow up. Timepoint: At 3 months follow up	—

Countries

India

Contacts

Public ContactPROF AMIT BAHL

PGIMER, CHANDIGARH

dramitbahl@yahoo.com8219586371

Outcome results

None listed

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