Status:

NOT_YET_RECRUITING

Trial Comparing Avg. Global Qual of Lifescore in Hypo Frac. RT vs Conv. Frac. in H&N Cancers

Lead Sponsor:

Tata Medical Center

Conditions:

Radiation Treatment

Eligibility:

All Genders

18-80 years

Phase:

NA

Brief Summary

Radiotherapy forms an integral part of Head and Neck cancer treatment in both definitive as well as adjuvant setting. This study explores the use of hypofractionated radiotherapy, delivering 55Gy in 2...

Detailed Description

Head and neck cancers comprise of cancers of arising from the epithelial lining of the lip, oral cavity, pharynx and larynx. The overall incidence of Head and Neck cancers continues to increase, despi...

Eligibility Criteria

Inclusion

  • Age ≥ 18 years
  • ECOG performance status 0 - 2.
  • Patients diagnosed with invasive squamous cell cancer of the head and neck region which includes lip, oral cavity, nasopharynx, oropharynx, hypopharynx, supraglottis, glottis and subglottis.
  • Patients who are being treated with curative intent treatment either with surgery followed by adjuvant radiotherapy with or without chemotherapy or definitive chemoradiation.
  • Patients must have a histopathological proof of malignancy, such as biopsy or post operative histopathology report. Biopsies or surgeries done outside must have been reviewed for pathological confirmation and specimen adequacy at the treating institute.
  • Patients with non metastatic cancer, optimally staged with the following:
  • Contrast enhanced CT scan of the neck and thorax for cancer lip, oral cavity, oropharynx, hypopharynx, supraglottis, glottis and subglottis
  • Magnetic Resonance Imaging of the neck and CT thorax for cancer of nasopharynx

Exclusion

  • Concurrent illness like severe cardiac, renal or hepatic dysfunction and, including severe infection that may jeopardise the ability of the patient to undergo the procedures outlined in this protocol with reasonable safety
  • Serious medical or psychiatric conditions that might limit the ability of the patient to comply with the protocol.

Key Trial Info

Start Date :

August 7 2024

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

July 1 2031

Estimated Enrollment :

600 Patients enrolled

Trial Details

Trial ID

NCT06536699

Start Date

August 7 2024

End Date

July 1 2031

Last Update

August 5 2024

Active Locations (1)

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Tata Medical Center

Kolkata, West Bengal, India, 700160