Hypofractionated Chemoradiotherapy for Cervical Cancer

NCT07709650 | Not Yet Recruiting Phase 3

• 1 other identifier: Si 577/2569(IRB1)
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

Cervical cancer remains a major health problem in Thailand and other lowand middle-income countries. The current standard treatment for locally advanced cervical cancer consists of conventionally fractionated external beam radiotherapy delivered over 5-7 weeks with concurrent chemotherapy, followed by brachytherapy. This prolonged treatment schedule requires frequent hospital visits and may limit access to care. Hypofractionated radiotherapy delivers a higher dose of radiation per treatment session while maintaining a comparable total radiation dose, thereby reducing the overall treatment duration. Preliminary studies suggest that hypofractionated chemoradiotherapy using modern radiotherapy techniques may provide similar disease control and acceptable toxicity compared with conventional treatment, while improving treatment convenience and reducing healthcare burden. This multicenter phase III randomized controlled trial aims to compare hypofractionated whole pelvic concurrent chemoradiotherapy with conventional chemoradiotherapy in patients with early-stage node-positive and locally advanced cervical cancer. The study will evaluate nodal control and overall survival, as well as tumor response, treatment-related toxicities, quality of life, and cost-effectiveness.

Conditions

Cervival Cancer

Keywords

Cervical Cancer; Hypofractionated Radiotherapy; Conventional Radiotherapy; Whole Pelvic Radiotherapy; Chemoradiotherapy; Brachytherapy

Outcome Measures

Primary Outcomes (2)

• Nodal Recurrence-free Survival

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

  Up to 5 years after completion of radiotherapy

• Overall Survival (OS)

  Time from completion of radiotherapy to death from any cause.

  Up to 5 years after completion of radiotherapy

Secondary Outcomes (11)

• Tumor Response Rate

  Up to 12 months after completion of radiotherapy

• Local Recurrence-free Survival

  At 3 and 5 years after completion of radiotherapy

• Pelvic Recurrence-free Survival

  At 3 and 5 years after completion of radiotherapy

• Para-aortic Recurrence-free Survival

  At 3 and 5 years after completion of radiotherapy

• Locoregional Recurrence-free Survival

  At 3 and 5 years after completion of radiotherapy

Study Arms (2)

Conventional Chemoradiotherapy (CONV)

ACTIVE COMPARATOR

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.

Radiation: Conventional Chemoradiotherapy; Drug: Concurrent chemotherapy

Hypofractionated Chemoradiotherapy (HYPO)

EXPERIMENTAL

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.

Radiation: Hypofractionated Chemoradiotherapy; Drug: Concurrent chemotherapy

Interventions

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.

Hypofractionated Chemoradiotherapy (HYPO)

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.

Conventional Chemoradiotherapy (CONV)

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.

Conventional Chemoradiotherapy (CONV); Hypofractionated Chemoradiotherapy (HYPO)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• MRI, CT, or PET-CT of the retroperitoneal space and abdomen at diagnosis is performed
• MRI with the applicator in place at the time of (first) BT will be performed
• GFR ≥ 50 mL/min
• Patient informed consent

You may not qualify if:

• 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
• Previous total or subtotal hysterectomy
• Combination of preoperative radiotherapy with surgery
• Patients receiving BT only
• Patients receiving EBRT only
• Patients receiving neo-adjuvant chemotherapy or other forms of antineoplastic treatment apart from weekly concomitant cisplatin (40 mg/m2).
• Contra-indications to MRI
• Contra-indications to BT

Sponsors & Collaborators

• Mahidol University: lead
• Chiang Mai University: collaborator
• Prince of Songkla University: collaborator
• Siriraj Hospital: collaborator
• Ratchaburi Hospital: collaborator
• Tha Chalom Hospital: collaborator
• Chulabhorn Hospital: collaborator
• Lopburi Hospital: collaborator

Study Sites (1)

Siriraj Hospital

Bangkok Noi, Bangkok, 10700, Thailand

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Central Study Contacts

Tissana Prasartseree, MD

CONTACT

66625246101; tissana.p@gmail.com

Pittaya Dankulchai, MD

CONTACT

66966233606; pittaya.dan@mahidol.ac.th

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Model Details: Participants will be randomly assigned in a 1:1 ratio to receive either hypofractionated whole pelvic concurrent chemoradiotherapy or conventional fractionated concurrent chemoradiotherapy. Both treatment groups will receive IMRT/VMAT-based external beam radiotherapy with concurrent platinum-based chemotherapy followed by image-guided adaptive brachytherapy. Outcomes will be compared between the two parallel groups throughout the study follow-up period.

Study Record Dates

• First Submitted: July 12, 2026
• First Posted: July 16, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): June 1, 2031
• Study Completion (Estimated): June 1, 2033
• Last Updated: July 16, 2026

Record last verified: 2026-07

Locations

TH (1)