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Hypofractionated Chemoradiotherapy for Cervical Cancer (HYPOCx)

21 agosto 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

250

Fase

  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

  • Tailandia
    • Bangkok
      • Bangkok Noi, Bangkok, Tailandia, 10700
        • Reclutamento
        • Siriraj Hospital
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: 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.
Radiazione: 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.
Droga: 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.
Sperimentale: 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.
Droga: 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.
Radiazione: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Nodal Recurrence-free Survival
Lasso di tempo: 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)
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Local Recurrence-free Survival
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Mahidol University

Collaboratori

Siriraj Hospital

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

3 agosto 2026

Completamento primario (Stimato)

1 giugno 2031

Completamento dello studio (Stimato)

1 giugno 2033

Date di iscrizione allo studio

Primo inviato

12 luglio 2026

Primo inviato che soddisfa i criteri di controllo qualità

12 luglio 2026

Primo Inserito (Effettivo)

16 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

24 agosto 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

21 agosto 2026

Ultimo verificato

1 luglio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • Si 577/2569(IRB1)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

INDECISO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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