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Trial Comparing Avg. Global Qual of Lifescore in Hypo Frac. RT vs Conv. Frac. in H&N Cancers (HYPORT-HN) 600

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Die klinische Studie NCT06536699 (HYPORT-HN) ist eine interventionsstudie zur Untersuchung von Strahlenbehandlung und hat den Status noch nicht rekrutierend. Der Start ist für 7. August 2024 geplant, bis 600 Teilnehmer aufgenommen werden. Durchgeführt von Tata Medical Center wird der Abschluss für 1. Juli 2031 erwartet. Die Daten von ClinicalTrials.gov wurden zuletzt am 5. August 2024 aktualisiert.
Kurzbeschreibung
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 20 fractions over 4 weeks in comparison to the conventional approach which involves 70 Gy over 6 weeks.

Hypofractionated radiotherapy would result in significant benefits in terms of shortening the overall treatment time...

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Ausführliche Beschreibung
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, despite decrease in the incidence of smoking suggestive of potential change in etiology. Presently Head and Neck cancer form the seventh most common cancer globally The primary treatment of oral cavity cancer comprises of sur...Mehr anzeigen
Offizieller Titel

A Randomised Non Inferiority Trial to Compare the Average Global Quality of Life Score Following Hypofractionated Radiotherapy Versus Conventional Fractionation in Head and Neck Cancers

Erkrankungen
Strahlenbehandlung
Publikationen
Wissenschaftliche Artikel und Forschungspapiere zu dieser klinischen Studie:
Weitere Studien-IDs
  • HYPORT-HN
  • 2024/TMC/307/IRB11
NCT-Nummer
NCT06536699
Studienbeginn (tatsächlich)
2024-08-07
Zuletzt aktualisiert
2024-08-05
Studienende (vorauss.)
2031-07-01
Geplante Rekrutierung
600
Studientyp
Interventionsstudie
PHASE
Nicht zutreffend
Status
Noch nicht rekrutierend
Stichwörter
Hypofractionated radiotherapy
Head and Neck cancer
Primäres Ziel
Behandlung
Zuteilungsmethode
Randomisiert
Interventionsmodell
Parallel
Verblindung
Keine (offene Studie)
Studienarme/Interventionen
Teilnehmergruppe/StudienarmIntervention/Behandlung
Aktives VergleichspräparatRadiotherapy - conventional
Conventional Radiotherapy of 66 Gy in 30 fractions in definitive setting and 60 Gy in 30 fractions in adjuvant setting Total Duration- 6 weeks
Radiotherapy - Conventional
Conventional Radiotherapy of 66 Gy in 30 fractions in definitive setting and 60 Gy in 30 fractions in adjuvant setting. Total duration - 6 Weeks
ExperimentellRadiotherapy - 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
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
Hauptergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
To compare the average global quality of life score following hypofractionated radiotherapy versus conventional fractionation in head and neck cancer
Patients reported outcomes in the form of EORTC QLQ C30 questionnaire at regular designated intervals using electronic patient reported outcome monitoring systems (e-PROMS). EORTC QLQ C30 stands for European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire C30. The score will range from 0 to 100 as per the Scoring of the EORTC QLQ-C30 version 3.0. A higher score will denote a better quality of life.
2 Years
Nebenergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
To compare the locoregional control at 2 years between the hypofractionated and conventional arm.
To get a Radiological assessment done 3 months post treatment and then followup the patient clinically and only get a radiological correlation if suggested clinically.
2 Years
To compare acute and late toxicities of hypofractionated radiotherapy with conventional fractionation
To compare physician reported and patient reported acute toxicities like mucositis, dermatitis and dysphagia between the two groups using weekly assessment of acute toxicities using the RTOG and CTCAE v5 criteria during radiation.
2 Years
Teilnahme-Assistent
Eignungskriterien

Zugelassene Altersgruppen
Erwachsene, Ältere Erwachsene
Mindestalter
18 Years
Zugelassene Geschlechter
Alle

  1. Age ≥ 18 years

  2. ECOG performance status 0 - 2.

  3. 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.

  4. Patients who are being treated with curative intent treatment either with surgery followed by adjuvant radiotherapy with or without chemotherapy or definitive chemoradiation.

  5. 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.

  6. Patients with non metastatic cancer, optimally staged with the following:

    1. Contrast enhanced CT scan of the neck and thorax for cancer lip, oral cavity, oropharynx, hypopharynx, supraglottis, glottis and subglottis
    2. Magnetic Resonance Imaging of the neck and CT thorax for cancer of nasopharynx

  1. 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
  2. Serious medical or psychiatric conditions that might limit the ability of the patient to comply with the protocol.
Tata Medical Center logoTata Medical Center
Zentrale Studienkontakte
Kontakt: Sanjoy Sanjoy, MRCP,FRCR, 9038161825, [email protected]
Kontakt: Indranil Mallick, MD, DNB, 9831171235, [email protected]
1 Studienstandorte in 1 Ländern

West Bengal

Tata Medical Center, Kolkata, West Bengal, 700160, India
Sanjoy Chatterjee, MRCP,FRCR, Kontakt, 9038161825, [email protected]
Indranil Mallick, MD, DNB, Prüfarzt