Hypofractionated Whole Pelvic Chemoradiotherapy With iRex Optimization in Cervical Cancer

NCT07605507 | Active Not Recruiting

• 1 other identifier: Si 149/2564(IRB3)
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a randomized controlled trial designed to compare hypofractionated whole pelvic radiotherapy with conventional radiotherapy in patients with cervical cancer undergoing concurrent chemoradiotherapy. Hypofractionated radiotherapy delivers a higher dose per treatment over a shorter overall treatment time, which may reduce the number of hospital visits and improve treatment convenience for patients. Conventional radiotherapy requires more treatment sessions over a longer period. The purpose of this study is to evaluate whether hypofractionated radiotherapy is as safe and effective as conventional radiotherapy. The primary outcomes focus on treatment-related toxicity, while secondary outcomes include tumor response, survival outcomes, quality of life, and treatment-related factors. In addition, this study will evaluate a novel planning approach called the indirect excess dose volume ratio (iRex) to optimize brachytherapy planning and potentially reduce radiation-related side effects.

Conditions

Cervical Cancer

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Incidence of Acute Treatment-Related Toxicity

  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

  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

Secondary Outcomes (12)

• Tumor Response Rate

  Up to 12 months after completion of radiotherapy

• Quality of Life Assessed by EQ-5D-5L

  During treatment and up to 5 years after completion of radiotherapy

• Local Recurrence-free Survival

  At 3 and 5 years after completion of radiotherapy

• Nodal Recurrence-free Survival

  At 3 and 5 years after completion of radiotherapy.

• Distant Metastasis-free Survival

  At 3 and 5 years after completion of radiotherapy.

Study Arms (4)

HYPO + iREX

EXPERIMENTAL

Participants receive hypofractionated whole pelvic radiotherapy with concurrent chemotherapy followed by image-guided adaptive brachytherapy optimized using iRex in addition to standard D2cc constraints.

Radiation: Hypofractionated Radiotherapy; Drug: Concurrent chemotherapy once a week; Procedure: Image-guided Adaptive Brachytherapy; Procedure: iReX Optimization

HYPO + Standard Planning

EXPERIMENTAL

Participants receive hypofractionated whole pelvic radiotherapy with concurrent chemotherapy followed by image-guided adaptive brachytherapy using standard D2cc constraints without iRex optimization.

Radiation: Hypofractionated Radiotherapy; Drug: Concurrent chemotherapy once a week; Procedure: Image-guided Adaptive Brachytherapy; Procedure: Standard D2cc Planning

CVRT + iREX

ACTIVE COMPARATOR

Participants receive conventional fractionated whole pelvic radiotherapy with concurrent chemotherapy followed by image-guided adaptive brachytherapy optimized using iRex.

Radiation: Conventional Radiotherapy; Drug: Concurrent chemotherapy once a week; Procedure: Image-guided Adaptive Brachytherapy; Procedure: iReX Optimization

CVRT + Standard Planning

ACTIVE COMPARATOR

Participants receive conventional fractionated whole pelvic radiotherapy with concurrent chemotherapy followed by image-guided adaptive brachytherapy using standard planning without iRex.

Radiation: Conventional Radiotherapy; Drug: Concurrent chemotherapy once a week; Procedure: Image-guided Adaptive Brachytherapy; Procedure: Standard D2cc Planning

Interventions

Hypofractionated Radiotherapy RADIATION

Whole pelvic radiotherapy delivered using hypofractionation (2.2 Gy per fraction over 20 fractions) with IMRT.

HYPO + Standard Planning; HYPO + iREX

Conventional Radiotherapy RADIATION

Whole pelvic radiotherapy delivered using conventional fractionation (1.8 Gy per fraction over 25 fractions) with IMRT.

CVRT + Standard Planning; CVRT + iREX

Concurrent chemotherapy once a week DRUG

Cisplatin-based concurrent chemotherapy administered intravenously at a dose of 40 mg/m² once weekly during external beam radiotherapy for 5 to 6 cycles.

CVRT + Standard Planning; CVRT + iREX; HYPO + Standard Planning; HYPO + iREX

Image-guided Adaptive Brachytherapy PROCEDURE

Image-guided adaptive brachytherapy delivered following external beam radiotherapy.

CVRT + Standard Planning; CVRT + iREX; HYPO + Standard Planning; HYPO + iREX

iReX Optimization PROCEDURE

Brachytherapy treatment planning optimized using iReX in addition to standard D2cc constraints.

CVRT + iREX; HYPO + iREX

Standard D2cc Planning PROCEDURE

Conventional brachytherapy treatment planning using standard D2cc constraints without iReX optimization.

CVRT + Standard Planning; HYPO + Standard Planning

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
• Staging according to FIGO 2018 and TNM guidelines
• 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

• Siriraj Hospital: lead

Study Sites (1)

Siriraj Hospital

Bangkok, Bangkok, Thailand

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Radiation Dose Hypofractionation

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

Intervention Hierarchy (Ancestors)

Dose Fractionation, Radiation; Radiotherapy Dosage; Radiotherapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 16, 2026
• First Posted: May 26, 2026
• Study Start: July 15, 2021
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): July 31, 2028
• Last Updated: May 26, 2026

Record last verified: 2026-05

Locations

TH (1)