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Comparison of a shorter course of radiotherapy in 4 weeks with standard treatment of 6 weeks for head and neck cancers

HYPORT HN-A randomized, non inferiority trial to compare the the average global quality of life score following HYPofractionated radiotherapy versus conventional fractionation in Head and Neck cancer - HYPORT HN

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/05/068150
Enrollment
600
Registered
2024-05-31
Start date
Unknown
Completion date
Unknown
Last updated
2024-06-24

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: Radiotherapy- hypofractionated: Hypofractionated Radiotherapy of 55 Gy in 20 fractions in definitive setting and 52.5 Gy in 20 fractions in adjuvant setting. Total duration - 4 Weeks Co

Sponsors

TATA MEDICAL CENTER KOLKATA
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1)Age = 18 years 2)ECOG performance status 0 - 2. 3)Patients diagnosed with invasive squamous cell cancer of the head and neck region including lip, oral cavity, nasopharynx, oropharynx, hypopharynx, and larynx 4)Patients with non metastatic cancer, optimally staged with the following: a)Contrast enhanced CT or MRI scan of the neck and CT of the thorax (or whole body FDG PET-CT scan) for cancer lip, oral cavity, oropharynx, hypopharynx, supraglottis, glottis and subglottis b)Magnetic Resonance Imaging of the neck and Whole body PET-CT for cancer of nasopharynx 5)Patients who are being treated with curative intent treatment either with radiotherapy or concurrent chemoradiotherapy, neoadjuvant chemotherapy followed by curative radiotherapy or chemoradiotherapy, or primary surgery followed by adjuvant radiotherapy or chemoradiotherapy. Patients must have a histopathological proof of malignancy, such as biopsy or postoperative histopathology report. Biopsies or surgeries done outside must have been reviewed for pathological confirmation and specimen adequacy at the treating institute.

Exclusion criteria

Exclusion criteria: 1)Concurrent illness like severe cardiac, renal or hepatic dysfunction and severe infection that may jeopardise the ability of the patient to undergo the procedures outlined in this protocol with reasonable safety after discussion in MDT 2)Serious medical or psychiatric conditions that might limit the ability of the patient to comply with the protocol.

Design outcomes

Primary

MeasureTime frame
To compare the average global quality of life score following hypofractionated radiotherapy versus conventional fractionation in head and neck cancerTimepoint: 2 years

Secondary

MeasureTime frame
To compare the locoregional control at 2 years between the hypofractionated and conventional arm. To compare acute and late toxicities of hypofractionated radiotherapy with conventional fractionationTimepoint: 2 years

Countries

India

Contacts

Public ContactDr Sanjoy Chatterjee

TATA MEDICAL CENTER

chatterjee72@hotmail.com9038161825

Outcome results

None listed

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