A pilot study to evaluate a novel regimen of radiotherapy in post-operative patients of head and neck cancers

An essential need during the COVID pandemic: Hypofractionated adjuvant radiotherapy in resected head and neck cancers - HYPO-ART

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/07/034608

Enrollment

Registered

2021-07-06

Start date

Unknown

Completion date

Unknown

Last updated

2022-10-17

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: Hypofractionated adjuvant radiotherapy post-surgery in head and neck cancers: Standard conformal radiotherapy will be given at 2.5 Gy per day, 5 days per week, for 4 weeks (50 Gy in tot

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients with resected head and neck squamous cell cancers with clinical/pathological stage III or stage IV and/or with indications of adjuvant radiotherapy post-surgery 2. WHO ECOG Performance Score of 2 or less. 3. Patients 18 to 70 years age 4. Haemoglobin > 10gm/dL, TLC > 4000/mm3 and Platelet count > 100,000/mm3. 5. Normal liver, renal lung and cardiac function. 6. No evidence of a second primary elsewhere in the body.

Exclusion criteria

Exclusion criteria: 1. Cancers with histology other than squamous cell carcinoma 2. Patients who are medically unfit for surgery or not willing for surgery. 3. Distant metastases (Stage IVC) 4. Patients with history of prior malignancy. 5. Patients having received prior chemotherapy and radiotherapy to the head and neck. 6. Patients having undergone surgery involving primary tumour or lymph nodes (except diagnostic biopsy) 7. Patients with signs of severe ischaemic disease, severe arteriosclerosis, active coronary artery disease, cardiac arrhythmia, congestive cardiac failure, and a history of peripheral neuropathy or cerebral stroke.

Design outcomes

Primary

Measure	Time frame
Incidence of acute radiation-induced toxicities or complicationsTimepoint: Less than 90 days	—

Secondary

Measure	Time frame
Disease free survivalTimepoint: 2 years;Locoregional controlTimepoint: 2 years;Overall survivalTimepoint: 2 years;Quality of lifeTimepoint: Immediately post treatment, and at 2 years	—

Countries

India

Contacts

Public ContactDeep Chakrabarti

King Georges Medical University

deepchakrabarti.19@gmail.com9674321201

Outcome results

None listed

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