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Hypofractionated Chemoradiotherapy for Cervical Cancer (HYPOCx)

21. august 2026 oppdatert av: Tissana Prasartseree, Mahidol University

HYPOfractionated Whole Pelvic Concurrent Chemoradiotherapy in Cervical Cancer (HYPOCx Trial): A Phase III Randomized Controlled Trial

The goal of this clinical trial is to evaluate whether hypofractionated whole pelvic or extended-field concurrent chemoradiotherapy can improve treatment access and efficiency while potentially providing superior oncologic efficacy and safety compared to conventional chemoradiotherapy in patients with early-stage node-positive and locally advanced cervical cancer. Building on encouraging safety and efficacy outcomes from our Phase II HYPOCx-iRex trial (TCTR20210812003), this study will provide data for a critical evidence gap regarding the safety, feasibility, and oncologic efficacy of hypofractionated radiotherapy, including extended-field para-aortic treatment, delivered with concurrent chemotherapy.

The main questions it aims to answer are:

  • Does hypofractionated chemoradiotherapy achieve superior nodal control compared to conventional chemoradiotherapy?
  • Does hypofractionated chemoradiotherapy achieve superior overall survival compared to conventional chemoradiotherapy?

Researchers will compare patients receiving hypofractionated external beam radiotherapy to those receiving conventional fractionation to evaluate if the shortened hypofractionated schedule provides comparable disease control, acceptable toxicity, improved quality of life, and cost-effectiveness.

Participants will:

  • Be randomized to receive either hypofractionated external beam radiotherapy or conventional fractionation radiotherapy, both delivered using modern IMRT/VMAT techniques targeting either the whole pelvis or extended fields (including para-aortic lymph nodes).
  • Receive concurrent platinum-based chemotherapy during external beam radiation.
  • Complete image-guided adaptive brachytherapy following external beam radiotherapy.
  • Attend scheduled follow-up visits to evaluate tumor response, disease control, treatment-related toxicities, quality of life, and survival outcomes.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Cervical cancer remains a major contributor to cancer-related morbidity and mortality among women in low- and middle-income countries, including Thailand. Despite advancements in screening programs and human papillomavirus (HPV) vaccination, a substantial proportion of patients present with locally advanced disease necessitating definitive concurrent chemoradiotherapy.

The established standard of care for locally advanced cervical cancer consists of conventionally fractionated external beam radiotherapy (45 to 50.4 Gy delivered in 25 to 28 fractions) administered concurrently with platinum-based chemotherapy, followed by image-guided adaptive brachytherapy. However, this extended 5-to-7-week regimen imposes significant logistical and financial burdens on patients and healthcare infrastructure, contributing to prolonged overall treatment times, institutional capacity constraints, and restricted access to radiation oncology services. Although hypofractionated radiotherapy has established efficacy and safety in the treatment of breast, prostate, and rectal malignancies, high-level prospective evidence validating its application alongside concurrent chemotherapy in cervical cancer, particularly in the setting of extended-field irradiation, remains limited due to concerns regarding exacerbated gastrointestinal and hematologic toxicities.

To address these therapeutic constraints of conventional fractionation, our group conducted the Phase II HYPOCx-iRex trial (TCTR20210812003). Findings from the HYPOCx-iRex study provided essential clinical proof-of-concept, demonstrating that hypofractionated chemoradiotherapy delivered via advanced delivery techniques, such as IMRT/VMAT with adaptive brachytherapy, achieves acceptable gastrointestinal toxicity rates and promising short-term disease control relative to historical conventional benchmarks.

Building upon the foundation of the Phase II HYPOCx-iRex trial (TCTR20210812003), this multicenter Phase III randomized controlled superiority trial is designed to evaluate this hypofractionated paradigm. Crucially, this trial seeks to address the persistent lack of prospective evidence regarding the safety, feasibility, and oncologic efficacy of hypofractionated extended-field radiotherapy combined with concurrent platinum-based chemotherapy.

In this trial, patients with early-stage node-positive or locally advanced cervical cancer will be randomized to receive either hypofractionated or conventionally fractionated external beam radiotherapy, both administered using high-precision IMRT/VMAT techniques with concurrent chemotherapy and image-guided adaptive brachytherapy. The primary endpoints are nodal control and overall survival. Secondary endpoints encompass tumor response rate, locoregional control, event-free survival, acute and late toxicities, quality of life, and health economic cost-effectiveness. The trial's findings are anticipated to generate high-level clinical evidence capable of demonstrating superior therapeutic and operational value, mitigating treatment delays, and establishing a more accessible, resource-efficient treatment standard.

Studietype

Intervensjonell

Registrering (Antatt)

250

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

  • Thailand
    • Bangkok
      • Bangkok Noi, Bangkok, Thailand, 10700
        • Rekruttering
        • Siriraj Hospital
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

Inclusion Criteria:

  1. Cancer of the uterine cervix considered suitable for curative treatment with definitive radio-(chemo)therapy including imaged-guided BT
  2. Positive biopsy showing squamous-cell carcinoma, adenocarcinoma, or adeno-squamous cell carcinoma of the uterine cervix
  3. Locally advanced staging according to FIGO 2018 and TNM guidelines (Stage IA1-IVA)
  4. MRI of the pelvis at diagnosis is performed
  5. MRI, CT, or PET-CT of the retroperitoneal space and abdomen at diagnosis is performed
  6. MRI with the applicator in place at the time of (first) BT will be performed
  7. GFR ≥ 50 mL/min
  8. Patient 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 and other rare cancers in the cervix
  3. Metastatic disease beyond intervertebral disc L2/3 level
  4. Previous pelvic or abdominal radiotherapy
  5. Previous total or subtotal hysterectomy
  6. Combination of preoperative radiotherapy with surgery
  7. Patients receiving BT only
  8. Patients receiving EBRT only
  9. Patients receiving neo-adjuvant chemotherapy or other forms of antineoplastic treatment apart from weekly concomitant cisplatin (40 mg/m2).
  10. Contra-indications to MRI
  11. Contra-indications to BT

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: Conventional Chemoradiotherapy (CONV)
Participants assigned to this arm will receive conventionally fractionated whole pelvic external beam radiotherapy (45 Gy in 25 fractions or equivalent institutional standard) using IMRT/VMAT techniques, administered concurrently with weekly platinum-based chemotherapy, followed by image-guided adaptive brachytherapy according to institutional protocols.
Stråling: Conventional Chemoradiotherapy
Whole pelvic external beam radiotherapy delivered using IMRT or VMAT techniques at a dose of 45 Gy in 25 fractions (1.8 Gy per fraction), administered once daily, five fractions per week. Treatment is given concurrently with weekly platinum-based chemotherapy and followed by image-guided adaptive brachytherapy according to institutional protocols.
Legemiddel: Concurrent chemotherapy
Concurrent chemotherapy once a week Cisplatin-based concurrent chemotherapy administered intravenously at a dose of 40 mg/m² once weekly during external beam radiotherapy for 5 to 6 cycles.
Eksperimentell: Hypofractionated Chemoradiotherapy (HYPO)
Participants assigned to this arm will receive hypofractionated whole pelvic external beam radiotherapy (44 Gy in 20 fractions) using IMRT/VMAT techniques, administered concurrently with weekly platinum-based chemotherapy, followed by image-guided adaptive brachytherapy according to institutional protocols.
Legemiddel: Concurrent chemotherapy
Concurrent chemotherapy once a week Cisplatin-based concurrent chemotherapy administered intravenously at a dose of 40 mg/m² once weekly during external beam radiotherapy for 5 to 6 cycles.
Stråling: Hypofractionated Chemoradiotherapy
Whole pelvic external beam radiotherapy delivered using IMRT or VMAT techniques at a dose of 44 Gy in 20 fractions (2.2 Gy per fraction), administered once daily, five fractions per week. Treatment is given concurrently with weekly platinum-based chemotherapy and followed by image-guided adaptive brachytherapy according to institutional protocols.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Nodal Recurrence-free Survival
Tidsramme: Up to 5 years after completion of radiotherapy
Time from completion of radiotherapy to the first occurrence of nodal recurrence
Up to 5 years after completion of radiotherapy
Overall Survival (OS)
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Local Recurrence-free Survival
Tidsramme: At 3 and 5 years after completion of radiotherapy
Time from completion of radiotherapy to local tumor recurrence.
At 3 and 5 years after completion of radiotherapy
Incremental Cost-effectiveness Ratio per Quality-adjusted Life Year Between Hypofractionated and Conventional Radiotherapy
Tidsramme: 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 oneway sensitivity analysis, probabilistic sensitivity analysis, and threshold analysis.
During treatment and follow-up up to 5 years after completion of radiotherapy.
Tumor Response Rate
Tidsramme: Up to 12 months after completion of radiotherapy
Tumor response rate assessed after external beam radiotherapy and at 3-, 6-, and 12-month follow-up after treatment.
Up to 12 months after completion of radiotherapy
Pelvic Recurrence-free Survival
Tidsramme: At 3 and 5 years after completion of radiotherapy
Time from completion of radiotherapy to pelvic recurrence.
At 3 and 5 years after completion of radiotherapy
Para-aortic Recurrence-free Survival
Tidsramme: At 3 and 5 years after completion of radiotherapy
Time from completion of radiotherapy to para-aortic recurrence.
At 3 and 5 years after completion of radiotherapy
Locoregional Recurrence-free Survival
Tidsramme: At 3 and 5 years after completion of radiotherapy
Time from completion of radiotherapy to local, pelvic, or para-aortic recurrence.
At 3 and 5 years after completion of radiotherapy
Distant Metastasis-free Survival
Tidsramme: At 3 and 5 years after completion of radiotherapy
Time from completion of radiotherapy to distant metastasis.
At 3 and 5 years after completion of radiotherapy
Event-free Survival
Tidsramme: Up to 5 years after completion of radiotherapy
Time from completion of radiotherapy to disease recurrence, disease progression, initiation of salvage treatment, or death from any cause
Up to 5 years after completion of radiotherapy
Incidence of Acute Treatment-related Toxicity
Tidsramme: During treatment and up to 3 months after completion of radiotherapy
Incidence of acute treatment-related toxicity during radiotherapy and at 1- and 3-month follow-up after treatment, assessed using CTCAE version 5.0.
During treatment and up to 3 months after completion of radiotherapy
Incidence of Late (Chronic) Treatment-related Toxicity
Tidsramme: From 6 months up to 5 years after completion of radiotherapy
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
Quality of Life Assessed by EQ-5D-5L
Tidsramme: During treatment and 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.
During treatment and up to 5 years after completion of radiotherapy

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Mahidol University

Samarbeidspartnere

Siriraj Hospital

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

3. august 2026

Primær fullføring (Antatt)

1. juni 2031

Studiet fullført (Antatt)

1. juni 2033

Datoer for studieregistrering

Først innsendt

12. juli 2026

Først innsendt som oppfylte QC-kriteriene

12. juli 2026

Først lagt ut (Faktiske)

16. juli 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

24. august 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

21. august 2026

Sist bekreftet

1. juli 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • Si 577/2569(IRB1)

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Nei

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