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Postoperative Hypofractionated Whole Pelvic Radiotherapy in Cervical and Endometrial Cancer (PostOP HYPOCxE)

12 mei 2026 bijgewerkt door: Wiwatchai Sittiwong, Siriraj Hospital

PostOPerative HYPOfractionated Whole Pelvic Radiotherapy in Cervical (Cx) and Endometrial Cancer (PostOP HYPOCxE Trial) : A Phase II Non-inferiority Randomized Controlled Trial

This study aims to evaluate a shorter course of postoperative pelvic radiotherapy in patients with cervical and endometrial cancer. The standard radiotherapy schedule usually requires many treatment sessions over several weeks, which can be burdensome for patients and may affect their ability to complete treatment.

This study will compare a shorter radiotherapy schedule (hypofractionated radiotherapy) with the standard schedule. Both treatments deliver a similar total radiation dose, but the shorter schedule reduces the number of hospital visits and overall treatment time.

Participants will be randomly assigned to receive either the shorter or standard radiotherapy after surgery. The study will evaluate side effects, treatment effectiveness, and quality of life. The goal is to determine whether the shorter treatment is as safe and effective as the standard approach.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

Cervical cancer remains a major health problem, particularly in low- and middle-income countries. Standard postoperative pelvic radiotherapy requires multiple treatment sessions over several weeks, which may limit patient access, increase treatment burden, and prolong overall treatment time. Prolonged treatment duration has been associated with reduced tumor control, and frequent hospital visits may also increase risks for patients, especially during infectious disease outbreaks.

Hypofractionated radiotherapy delivers a higher dose per fraction while maintaining a similar total radiation dose, allowing for a shorter overall treatment course. This approach may improve treatment convenience, reduce healthcare resource utilization, and potentially enhance treatment outcomes without increasing toxicity. However, there is currently limited high-level evidence supporting its use in the postoperative setting for cervical and endometrial cancer.

This study is a phase II randomized controlled trial designed to evaluate the safety and efficacy of postoperative hypofractionated whole pelvic radiotherapy compared with conventional radiotherapy in patients with cervical and endometrial cancer. Participants will be randomly assigned to receive either hypofractionated or standard radiotherapy following surgery.

The study will assess treatment-related toxicity, tumor response, survival outcomes, and quality of life. The results of this study may help establish whether a shorter radiotherapy schedule can be safely implemented as an alternative to standard treatment.

Studietype

Ingrijpend

Inschrijving (Geschat)

120

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • Thailand
    • Bangkok
      • Bangkok, Bangkok, Thailand
        • Werving
        • Siriraj Hospital
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

Inclusion Criteria:

  1. Pathologically proven carcinoma of the uterine cervix; and carcinoma and carcinosarcoma of uterine corpus
  2. Hysterectomy (total abdominal hysterectomy, vaginal hysterectomy, total laparoscopic hysterectomy or radical hysterectomy) for cancer of the cervix or endometrium within 49 days prior to registration. Hence inadvertent surgery will be allowed for inclusion.
  3. Indicated for adjuvant EBRT from multidisciplinary team discussion.
  4. Non-metastatic stage according to FIGO 2018 for Cervical cancer and FIGO 2023 for Endometrial cancer and TNM guidelines from appropriate diagnostic workup 4.1 History/physical examination within 45 days prior to registration 4.2 CT/MRI/PET-CT of abdomen/pelvis demonstrating the absence of distant metastasis, performed pre- or post-surgery within 90 days prior to registration 4.3 Chest x-ray or chest CT (or a PET/CT) performed within 90 days prior to registration
  5. Age ≥18 years old with informed consent

Exclusion Criteria:

  1. Other primary malignancies except carcinoma in situ of the cervix and basal cell carcinoma of the skin
  2. Small cell neuroendocrine cancer, melanoma, uterine sarcoma, and other rare cancers in the cervix and uterus
  3. Metastatic disease beyond intervertebral disc L2/3 level
  4. Previous pelvic or abdominal radiotherapy
  5. Combination of preoperative chemotherapy or radiotherapy with surgery
  6. Contra-indications to EBRT

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: CVRT
Participants receive standard postoperative whole pelvic radiotherapy.
Straling: Conventional Radiotherapy
Standard postoperative whole pelvic radiotherapy delivered using conventional fractionation with a lower dose per fraction over a greater number of treatment sessions.
Experimenteel: HYPO
Participants receive postoperative hypofractionated whole pelvic radiotherapy.
Straling: Hypofractionated Radiotherapy
Postoperative hypofractionated whole pelvic radiotherapy delivered with a higher dose per fraction and a reduced number of treatment sessions compared to conventional radiotherapy, while maintaining a similar total radiation dose.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Incidence of Acute Treatment-Related Toxicity
Tijdsspanne: During treatment and up to 3 months after completion of radiotherapy
The incidence of acute treatment-related toxicity during radiotherapy and at 1- and 3-month follow-up, assessed using CTCAE version 5.0.
During treatment and up to 3 months after completion of radiotherapy
Incidence of Late Treatment-Related Toxicity
Tijdsspanne: From 6 months up to 5 years after completion of radiotherapy
The incidence of late (chronic) treatment-related toxicity assessed at 6 and 12 months, and at 3 and 5 years after treatment, using CTCAE version 5.0.
From 6 months up to 5 years after completion of radiotherapy

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Tumor Response Rate
Tijdsspanne: Up to 12 months after completion of radiotherapy
Tumor response rate following external beam radiotherapy, assessed during the post-treatment period and at 3-, 6-, and 12-month follow-up.
Up to 12 months after completion of radiotherapy
Quality of Life Assessed by EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L)
Tijdsspanne: From baseline up to 5 years after completion of radiotherapy
Patient-reported quality of life assessed using the EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L) during treatment and at 1-, 3-, 6-, and 12-month, and 3- and 5-year follow-up. The EQ-5D-5L descriptive system evaluates mobility, self-care, usual activities, pain/discomfort, and anxiety/depression across 5 levels of severity. The EQ Visual Analog Scale (EQ-VAS) ranges from 0 to 100, with higher scores indicating better perceived health status.
From baseline up to 5 years after completion of radiotherapy
Local and Nodal Recurrence-Free Survival
Tijdsspanne: Up to 5 years after completion of radiotherapy
Time from treatment completion to local or nodal disease recurrence.
Up to 5 years after completion of radiotherapy
Distant Metastasis-Free Survival
Tijdsspanne: Up to 5 years after completion of radiotherapy
Time from treatment completion to distant metastasis
Up to 5 years after completion of radiotherapy
Overall Survival
Tijdsspanne: Up to 5 years after completion of radiotherapy.
Time from completion of radiotherapy to death from any cause.
Up to 5 years after completion of radiotherapy.
Incremental Cost-effectiveness Ratio per Quality-adjusted Life Year Between Hypofractionated and Conventional Radiotherapy
Tijdsspanne: During treatment and follow-up up to 5 years after completion of radiotherapy.
Cost and utility data will be used to evaluate cost-effectiveness by calculating the incremental cost-effectiveness ratio (ICER) between hypofractionated and conventional radiotherapy. Uncertainty analyses will be performed using one-way sensitivity analysis, probabilistic sensitivity analysis, and threshold analysis.
During treatment and follow-up up to 5 years after completion of radiotherapy.

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Siriraj Hospital

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

11 maart 2026

Primaire voltooiing (Geschat)

31 december 2026

Studie voltooiing (Geschat)

31 december 2028

Studieregistratiedata

Eerst ingediend

16 april 2026

Eerst ingediend dat voldeed aan de QC-criteria

12 mei 2026

Eerst geplaatst (Werkelijk)

19 mei 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

19 mei 2026

Laatste update ingediend die voldeed aan QC-criteria

12 mei 2026

Laatst geverifieerd

1 mei 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • Si 739/2567(IRB4)

Plan Individuele Deelnemersgegevens (IPD)

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Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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