Health Trials

Hypofractionated Chemoradiotherapy for Cervical Cancer

ConditionCervival Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18+
SponsorMahidol University

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Cancer of the uterine cervix considered suitable for curative treatment with definitive radio-(chemo)therapy including imaged-guided BT

Positive biopsy showing squamous-cell carcinoma, adenocarcinoma, or adeno-squamous cell carcinoma of the uterine cervix

Locally advanced staging according to FIGO 2018 and TNM guidelines (Stage IA1-IVA)

MRI of the pelvis at diagnosis is performed

Disqualifiers

Other primary malignancies except carcinoma in situ of the cervix and basal cell carcinoma of the skin

Small cell neuroendocrine cancer, melanoma and other rare cancers in the cervix

Metastatic disease beyond intervertebral disc L2/3 level

Previous pelvic or abdominal radiotherapy

Trial design

Design model

Parallel

Treatments tested in this trial

  • Hypofractionated Chemoradiotherapy

    Radiation

    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.

  • Conventional Chemoradiotherapy

    Radiation

    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.

  • Concurrent chemotherapy

    Drug

    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.

Treatment groups

250 Participants
are divided into 2 treatment groups
Group A: Conventional Chemoradiotherapy (CONV)Active comparator 2 interventions
Group B: Hypofractionated Chemoradiotherapy (HYPO)Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Nodal Recurrence-free Survival

Time from completion of radiotherapy to the first occurrence of nodal recurrence

Time frame
Up to 5 years after completion of radiotherapy
2

Overall Survival (OS)

Time from completion of radiotherapy to death from any cause.

Time frame
Up to 5 years after completion of radiotherapy

Secondary outcomes

1

Tumor Response Rate

Tumor response rate assessed after external beam radiotherapy and at 3-, 6-, and 12-month follow-up after treatment.

Time frame
Up to 12 months after completion of radiotherapy
2

Local Recurrence-free Survival

Time from completion of radiotherapy to local tumor recurrence.

Time frame
At 3 and 5 years after completion of radiotherapy
3

Pelvic Recurrence-free Survival

Time from completion of radiotherapy to pelvic recurrence.

Time frame
At 3 and 5 years after completion of radiotherapy
4

Para-aortic Recurrence-free Survival

Time from completion of radiotherapy to para-aortic recurrence.

Time frame
At 3 and 5 years after completion of radiotherapy

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mahidol University

Lead sponsor

Siriraj Hospital

Collaborator

Source ClinicalTrials.gov
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