Clinical trial · Interventional
Image Based Brachytherapy in Locally Advanced Cervical Cancers - a Randomized Controlled Trial
COnventional Radiography Based Intracavitary Brachytherapy (Standard Arm) Versus Magnetic Resonance Image Based BrAchyTherapy (Study Arm) in Locally Advanced Cervical Cancers: A Phase III Randomized Controlled Trial (COMBAT - Cervix Trial)
NCT03005743CI-TRIAL-00103872COMBAT-CxcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
Purpose of the study is to determine whether Image based brachytherapy is superior in terms of local control to Conventional radiograph based brachytherapy in locally advanced cervical cancers in a Phase III randomized setting.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Conventional Radiograph based Brachytherapy | Radiation | — | UNRESOLVED |
| Magnetic Resonance Image based Brachytherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- MR based BT
- description
- Magnetic Resonance Image based Brachytherapy
- interventionNames
- Radiation: Magnetic Resonance Image based Brachytherapy
- type
- OTHER
- label
- Conventional BT
- description
- Conventional Radiograph based Brachytherapy
- interventionNames
- Radiation: Conventional Radiograph based Brachytherapy
Primary outcomes (1)
- measure
- Local control
- timeFrame
- 2 years
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
Inclusion Criteria: * Cancer of the uterine cervix considered suitable for curative treatment with definitive radio-(chemo) therapy including MRI guided Brachytherapy. * Positive biopsy showing squamous-cell carcinoma, adenocarcinoma or adeno-squamous cell carcinoma of the uterine cervix. * Stage IIB/IIIB according to FIGO and tumor node metastasis (TNM) guidelines * Suitable for Brachytherapy boost * MRI of pelvis at diagnosis is performed * MRI, Computed Tomography (CT) or Positron Emission Tomography (PET) -CT of the retroperitoneal space and abdomen at diagnosis is performed to rule out Para-aortic lymph node metastasis. * Patient informed consent * Pre-treatment Haemoglobin level \>10 g/dL Exclusion Criteria: * Other primary malignancies except carcinoma in situ of the cervix and basal cell carcinoma of the skin. * Metastatic disease * Patients with para-aortic metastatic nodes (stage IVB) to the level of L2 vertebra or further dissemination * Previous pelvic or abdominal radiotherapy * Previous total or partial hysterectomy * Combination of preoperative radiotherapy with surgery * Patients receiving BT only * Patients receiving EBRT only * Patients receiving neoadjuvant chemotherapy * Contraindications to MRI * Contraindications to BT * Active infection or severe medical condition endangering treatment delivery. * Pregnant, lactating or childbearing potential without adequate contraception
References
Publications (21)
- BACKGROUNDPerez CA, Grigsby PW, Chao KS, Mutch DG, Lockett MA. Tumor size, irradiation dose, and long-term outcome of carcinoma of uterine cervix. Int J Radiat Oncol Biol Phys. 1998 May 1;41(2):307-17. doi: 10.1016/s0360-3016(98)00067-4. PMID 9607346
- BACKGROUNDChemoradiotherapy for Cervical Cancer Meta-analysis Collaboration (CCCMAC). Reducing uncertainties about the effects of chemoradiotherapy for cervical cancer: individual patient data meta-analysis. Cochrane Database Syst Rev. 2010 Jan 20;2010(1):CD008285. doi: 10.1002/14651858.CD008285. PMID 20091664
- BACKGROUNDVale C, Tierney J, Stewart L. Concomitant chemoradiotherapy for cervical cancer: a systematic review and meta-analysis of individual patient data. Gynecol Oncol. 2006 Feb;100(2):442-3. doi: 10.1016/j.ygyno.2005.09.018. Epub 2005 Oct 17. No abstract available. PMID 16229878
- BACKGROUNDGreen J, Kirwan J, Tierney J, Vale C, Symonds P, Fresco L, Williams C, Collingwood M. Concomitant chemotherapy and radiation therapy for cancer of the uterine cervix. Cochrane Database Syst Rev. 2005 Jul 20;2005(3):CD002225. doi: 10.1002/14651858.CD002225.pub2. PMID 16034873
- BACKGROUNDKirwan JM, Symonds P, Green JA, Tierney J, Collingwood M, Williams CJ. A systematic review of acute and late toxicity of concomitant chemoradiation for cervical cancer. Radiother Oncol. 2003 Sep;68(3):217-26. doi: 10.1016/s0167-8140(03)00197-x. PMID 13129628
- BACKGROUNDViswanathan AN, Beriwal S, De Los Santos JF, Demanes DJ, Gaffney D, Hansen J, Jones E, Kirisits C, Thomadsen B, Erickson B; American Brachytherapy Society. American Brachytherapy Society consensus guidelines for locally advanced carcinoma of the cervix. Part II: high-dose-rate brachytherapy. Brachytherapy. 2012 Jan-Feb;11(1):47-52. doi: 10.1016/j.brachy.2011.07.002. PMID 22265437
- BACKGROUNDTakenaka T, Yoshida K, Tachiiri S, Yamazaki H, Aramoto K, Furuya S, Yoshida M, Ban C, Tanaka E, Honda K. Comparison of dose-volume analysis between standard Manchester plan and magnetic resonance image-based plan of intracavitary brachytherapy for uterine cervical cancer. J Radiat Res. 2012 Sep;53(5):791-7. doi: 10.1093/jrr/rrs033. Epub 2012 Jul 10.