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Trial Evaluating Hypo-fractionated Accelerated Versus Conventional Fractionated Adjuvant RT in Head & Neck Malignancies (Radiotherapy)

5. maj 2026 opdateret af: Aman Sharma, All India Institute of Medical Sciences

The HYPCON 3 Trial A Phase II/III Randomized Study Evaluating Hypo-fractionated Accelerated Versus Conventional Fractionated Adjuvant Radiation Therapy in Head and Neck Malignancies

Hypo-fractionated radiotherapy reduces the OTT (overall treatment time) which may in turn reduce rapid accelerated repopulation of clonogenic cells during waiting period after surgery. If this holds true, there is a potential to achieve better loco-regional control in with PORT for HNSCC. There is a strong radiobiological and economic rationale for delivery hypo-fractionated radiotherapy in HNSCC. The HYPCON III trial will be aimed to reduce the number of fractions by 50% (30 fr to 15 fr)

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The current standard radiotherapy regimen for squamous cell carcinomas of the head and neck in the post operative setting is 60-66Gy in 30-33# delivered in 6 weeks with 5 fractions delivered per week. The aim of this study is to test whether a resource sparing, 3weeks, 15 fraction course of hypo-fractionated radiotherapy is non inferior to the conventional fractionation regimen delivering 30 fractions over6 weeks of post operative radiotherapy (PORT). Hypofractionation is already the standard of care in the treatment of cancers like breast cancer which has evolved from 50 Gy in 25 # to 40 Gy in 15# and finally to 26Gy in 5 # with similar tumor control rates and toxicity profiles.

Hypofractionation has shown promising results in prostate, lung cancer and CNS tumors. Hypofractionation has been initially explored in palliative setting for HNSCC. Unlike 2 dimensional RT deliver, recent past has seen a rapid evolution of RT delivery techniques like 3-dimensional conformal radiotherapy (3D CRT), intensity modulated radiotherapy (IMRT), image guided radiotherapy (IGRT), volumetric arc therapy (VMAT). It is now possible to spare adjoining critical organs at risk which make delivery of hypo-fractionated feasible for HNSCC. Recently, the IAEA multicentric trial in radical setting for HNSCC has proved equivalent results in term of both disease control and toxicity with delivery of hypo-fractionated RT. Shorter treatment time is more convenient to the patient. The reduction in the number of fractions required per patient will help in optimal unitization of radiotherapy resources, especially in a low/moderate income country like India where the burden of cancer hugely surpasses the resource availability. Hypo-fractionated schedules have potential to provide attractive cost benefits.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

369

Fase

  • Fase 2
  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Indien
    • Haryana
      • Jhajjar, Haryana, Indien
        • Rekruttering
        • Dr. Aman Sharma, Associate Professor, Radiation Oncology, NCI, AIIMS
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  • Patients with pT1-4 squamous cell carcinoma of oral cavity/ oropharynx/ larynx/ hypopharynx with any of the intermediate risk features:

    • Positive lymph node (s)
    • Perineural invasion
    • Lympho-vascular invasion
    • Close margins
  • Age 18-80yrs
  • ECOG performance status 0-1at time of surgery
  • Informed consent
  • Available FOR long term follow-up

Exclusion Criteria:

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Standard conventionally fractionated PORT Arm A
hypo-fractionated PORT Arm B
Stråling: Standard conventionally fractionated PORT
60Gy in 30 fractions over 6 weeks (5 fractions per week)
Eksperimentel: Hypo-fractionated PORT Arm B
Stråling: hypo-fractionated PORT
4Gy in 15 fractions over 3 weeks (5 fractions per week)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
loco-regional control at 24 months
Tidsramme: 24 months
24 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Samlet overlevelse
Tidsramme: 2 år
langsgående vurdering hver 3., 6., 12., 18., 24. måned
2 år
Livskvalitet EORTC QLQ C30
Tidsramme: 2 år

EORTC QLQC30-modul [longitudinal vurdering ved 3, 6, 12, 18 og 24 måneder] QLQ-C30 består af både multi-item-skalaer og enkelt-item-målinger. Disse omfatter fem funktionelle skalaer, tre symptomskalaer, en global helbredsstatus-/livskvalitetsskala og seks enkeltpunkter.

Hver af multi-item-skalaerne indeholder et forskelligt sæt af punkter - intet punkt forekommer i mere end én skala. Alle skalaer og enkelt-item-målinger har en score fra 0 til 100. En høj skala-score repræsenterer et højere responsniveau. Høj score for en funktionel skala repræsenterer et højt/sundt funktionsniveau, en høj score for global helbredsstatus/livskvalitet repræsenterer en høj livskvalitet, men en høj score for en symptomskala/punkt repræsenterer et højt symptomniveau/problemer.
2 år
swallowing function
Tidsramme: 2 years
using MD Anderson Dysphagia Inventory pre RT, post RT, 3, 6, 12, 18, 24 months
2 years
Disease free survival
Tidsramme: 2 years
longitudinal assessment every 3, 6, 12, 18, 24 months
2 years
Quality of life H&N 35
Tidsramme: 2 years
EORTC H&N 35 module [longitudinal assessment at 3, 6, 12, 18 and 24 months] The head & neck cancer module incorporates seven multi-item scales that assess pain, swallowing, senses (taste and smell), speech, social eating, social contact and sexuality. There are also eleven single items. For all items and scales (maximum score 100 and minimum score 0), high scores indicate more problems (i.e. there are no function scales in which high scores would mean better functioning). The scoring approach for the QLQ-H&N35 is identical in principle to that for the symptom scales / single items of the QLQ-C30.
2 years
RTOG Acute Toxicity Post Radiation therapy
Tidsramme: 90 days

Acute toxicity is the side effects that appear within 90 days after the radiation therapy and will be assessed using RTOG acute toxicity scale with grading from 0 to IV where 0 represents no findings and IV being the worst Findings. Higher values will be showing worsening of the condition.

it will be scored weekly during radiation.
90 days
RTOG Late toxicity post radiation therapy
Tidsramme: 2 years

late toxicity is the side effects that appear after 90 days following the radiation therapy and will be assessed using RTOG Late Radiation Morbidity Grading (Radiation Therapy Oncology Group) with maximum value of 4 showing very severe / disabling and minimum value of 0 showing no toxicity. Higher values will be showing worsening of the condition.

longitudinal assessment will be done every 3, 6, 12, 18, 24 months
2 years
Late Toxicity using LENT- SOMA scale
Tidsramme: 12 months

using the Late effects in normal tissues- subjective, objective, management, analytic (LENT SOMA) scale.

assessment will be done at 3-, 6-and 12 months posttreatment.
12 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

All India Institute of Medical Sciences

Samarbejdspartnere

Indian Council of Medical Research

Efterforskere

  • Ledende efterforsker: Dr. Aman Sharma, National cancer Institute, AIIMS, Jhajjar

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

10. februar 2026

Primær færdiggørelse (Anslået)

30. juni 2028

Studieafslutning (Anslået)

30. december 2028

Datoer for studieregistrering

Først indsendt

28. april 2026

Først indsendt, der opfyldte QC-kriterier

5. maj 2026

Først opslået (Faktiske)

7. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

7. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

5. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • AIIMSHYPCON03
  • I-1921 (Anden identifikator: ICMR)

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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