Comparative study of high dose per fraction Radiotherapy versus conventional postoperative Radiotherapy in Head and Neck Malignancies

The HYPCON Trial : A Phase II Randomised Study evaluating HYPOFRACTIONATED versus CONVENTIONAL adjuvant Radiation therapy in Head and Neck Malignancies

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/02/049804

Enrollment

Registered

2023-02-17

Start date

Unknown

Completion date

Unknown

Last updated

2023-08-21

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

Conditions

Health Condition 1: C029- Malignant neoplasm of tongue, unspecified

Interventions

Intervention1: HYPOFRACTIONATED RADIOTHERAPY: Patients will undergo post operative adjuvant radiotherapy at 50 gy in 20 fractions over 4 weeks Control Intervention1: CONVENTIONAL RADIOTHERAPY: Patien

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients with pT1-4 squamous cell carcinoma of oral cavity/oropharynx/larynx/hypopharynx with any of the intermediate risk features A) T3/T4 disease (AJCC 8th edition) B) Positive lymph node (s) C) Perineural invasion D) Lymphovascular invasion E) Close margins 2. Age 18 – 80yrs 3. ECOG performance status 0-1 at time of surgery 4. Informed consent 5.Available to attend long term follow- up

Exclusion criteria

Exclusion criteria: 1. High risk factors following resection: positive margin(s) and/or ENE (extra nodal extension) 2. pT1-2 disease and no high-risk features (LVSI, PNI, Close margins, pN0) 3. Patients receiving Neoadjuvant or concurrent Chemotherapy 4. Non-Squamous Histology 5. Distant metastasis 6. Synchronous or second primary malignancies outside of the oropharynx, oral cavity, larynx and hypopharynx 7. Pregnant females or nursing mothers due to the probability of congenital anomalies and potential of this regimen to harm nursing infants 8. Prior Radiotherapy to head and neck region

Design outcomes

Primary

Measure	Time frame
Loco-regional control in patients receiving hypofractionated adjuvant radiotherapy versus conventional fractionation radiotherapy Timepoint: at 12 months	—

Secondary

Measure	Time frame
1. Loco-regional control: at follow-up visits 3-, 6- and 12-months post treatment 2.Disease free survival at follow-up visits 3-, 6- and 12-months post treatment 3.Overall survival at follow-up visits 3-, 6- and 12-months post treatment 4. Acute toxicity (RTOG acute morbidity grading) assessed a weekly during radiotherapy course. Late toxicity assessed by RTOG Late Radiation Morbidity Grading and the LENT SOMA scale at follow-up visits 3, 6 and 12 months post treatment. 5. Quality of Life assessed by EORTC-QOLqC30 & HN35 at baseline and follow- up visits 3-, 6- and 12-months post treatment. Timepoint: 3,6,AND 12 MONTHS	—

Measure

Time frame

1. Loco-regional control: at follow-up visits 3-, 6- and 12-months post treatment 2.Disease free survival at follow-up visits 3-, 6- and 12-months post treatment 3.Overall survival at follow-up visits 3-, 6- and 12-months post treatment 4. Acute toxicity (RTOG acute morbidity grading) assessed a weekly during radiotherapy course. Late toxicity assessed by RTOG Late Radiation Morbidity Grading and the LENT SOMA scale at follow-up visits 3, 6 and 12 months post treatment. 5. Quality of Life assessed by EORTC-QOLqC30 & HN35 at baseline and follow- up visits 3-, 6- and 12-months post treatment. Timepoint: 3,6,AND 12 MONTHS

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Countries

India

Contacts

Public ContactDr Adrija Ghosh

AIIMS, NEW DELHI

amans757@gmail.com9163278169

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 5, 2026