Clinical trial · Interventional
Hypofractionated Whole Pelvic Chemoradiotherapy With iRex Optimization in Cervical Cancer
HYPOfractionated Whole Pelvic Concurrent Chemoradiotherapy in Cervical (Cx) Cancer With "Indirect Excess Dose Volume Ratio (iRex)" - Optimized Image Guided Adaptive Brachytherapy (HYPOCx-iRex Trial) : A Phase II Non-inferiority Randomized Controlled Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Concurrent chemotherapy once a week | Drug | — | UNRESOLVED |
| Conventional Radiotherapy | Radiation | — | UNRESOLVED |
| Hypofractionated Radiotherapy | Radiation | — | UNRESOLVED |
| Image-guided Adaptive Brachytherapy | Procedure | — | UNRESOLVED |
| iReX Optimization | Procedure | — | UNRESOLVED |
| Standard D2cc Planning | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- HYPO + iREX
- description
- Participants receive hypofractionated whole pelvic radiotherapy with concurrent chemotherapy followed by image-guided adaptive brachytherapy optimized using iRex in addition to standard D2cc constraints.
- interventionNames
- Radiation: Hypofractionated Radiotherapy
- Drug: Concurrent chemotherapy once a week
- Procedure: Image-guided Adaptive Brachytherapy
- Procedure: iReX Optimization
- type
- EXPERIMENTAL
- label
- HYPO + Standard Planning
- description
- Participants receive hypofractionated whole pelvic radiotherapy with concurrent chemotherapy followed by image-guided adaptive brachytherapy using standard D2cc constraints without iRex optimization.
- interventionNames
- Radiation: Hypofractionated Radiotherapy
- Drug: Concurrent chemotherapy once a week
- Procedure: Image-guided Adaptive Brachytherapy
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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. Staging according to FIGO 2018 and TNM guidelines 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
References
Publications (0)
Data not yet available