Clinical trial · Interventional
Single Application Brachytherapy in Cervical Cancer
A Feasibility and Safety Study of Single Application Multi-fractionated High Dose Rate (HDR) Brachytherapy in Locally Advanced Cervical Cancer
NCT03110497CI-TRIAL-00035658unknownN/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)
The purpose of the study is to evaluate safety and feasibility of single brachytherapy application with dose delivery in multiple fractions. Study will be conducted in Phase I/II clinical trial setting with strict Image guidance protocol.This study is expected reduce treatment duration and to increase ease and acceptability of brachytherapy in patients along with significant saving of resources
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Single application multi-fraction brachytherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Single application brachytherapy
- description
- After external beam radiotherapy with or without chemotherapy as per standard, each study patient will undergo single application brachytherapy to deliver 3 High Dose Rate (HDR) fractions \[1st, 2nd and 3rd fractions of doses 9 Gy, 7 Gy and 7 Gy respectively\] keeping 6-12 hours of interval. All patients will undergo an inter-fraction Computed Tomography (CT) scan before delivery of second fraction. Plan will be re-optimized to reduce the dose to Organs at Risk (OAR's), only if the dose exceeds the dose constraints. Dose constraints being exceedingly hard in 1st fraction or before 2nd fraction even after re-planning will deem patient non-feasible but optimization will be done to give preference to OAR's while accepting some compromise in target doses.
- interventionNames
- Radiation: Single application multi-fraction brachytherapy
Primary outcomes (1)
- measure
- Number of participants achieving specified dosimetric constraints
- timeFrame
- 1 year
- description
- Number of participants achieving protocol specified dosimetric constraints will be measured, these dosimetric constraints are considered as a measure of safety. If not more than 20% of participants fail to achieve dosimetric constraints, trial will be considered feasible.
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
Inclusion Criteria: * Histologically diagnosed invasive cervical cancer (squamous carcinoma, adenosquamous carcinoma, adenocarcinoma) * International Federation of Gynecology and Obstetrics (FIGO) stage 2b-4a after thorough clinical examination and work-up investigation * Suitable for radical radiation therapy with/without chemotherapy, and also for brachytherapy boost * Accepts the Informed consent process and signs the form on his/her will. Exclusion Criteria: * Patients with vesico-vaginal fistula or recto-vaginal fistula at diagnosis * Patients at high risk of anaesthesia and patients with phobia /contra-indications to undergo MRI * Patients not suitable for brachytherapy * Metastatic disease beyond iliac on standard imaging * Vault cancers/recurrence * Previous history of pelvic radiation * Non-compliance to treatment * Medical or psychological illness precluding treatment protocol
References
Publications (8)
- BACKGROUNDTanderup K, Nielsen SK, Nyvang GB, Pedersen EM, Rohl L, Aagaard T, Fokdal L, Lindegaard JC. From point A to the sculpted pear: MR image guidance significantly improves tumour dose and sparing of organs at risk in brachytherapy of cervical cancer. Radiother Oncol. 2010 Feb;94(2):173-80. doi: 10.1016/j.radonc.2010.01.001. PMID 20138380
- BACKGROUNDLindegaard JC, Fokdal LU, Nielsen SK, Juul-Christensen J, Tanderup K. MRI-guided adaptive radiotherapy in locally advanced cervical cancer from a Nordic perspective. Acta Oncol. 2013 Oct;52(7):1510-9. doi: 10.3109/0284186X.2013.818253. Epub 2013 Aug 21. PMID 23962242
- BACKGROUNDPotter R, Dimopoulos J, Georg P, Lang S, Waldhausl C, Wachter-Gerstner N, Weitmann H, Reinthaller A, Knocke TH, Wachter S, Kirisits C. Clinical impact of MRI assisted dose volume adaptation and dose escalation in brachytherapy of locally advanced cervix cancer. Radiother Oncol. 2007 May;83(2):148-55. doi: 10.1016/j.radonc.2007.04.012. PMID 17531904
- BACKGROUNDPotter R, Georg P, Dimopoulos JC, Grimm M, Berger D, Nesvacil N, Georg D, Schmid MP, Reinthaller A, Sturdza A, Kirisits C. Clinical outcome of protocol based image (MRI) guided adaptive brachytherapy combined with 3D conformal radiotherapy with or without chemotherapy in patients with locally advanced cervical cancer. Radiother Oncol. 2011 Jul;100(1):116-23. doi: 10.1016/j.radonc.2011.07.012. Epub 2011 Aug 5. PMID 21821305
- BACKGROUNDSturdza A, Potter R, Fokdal LU, Haie-Meder C, Tan LT, Mazeron R, Petric P, Segedin B, Jurgenliemk-Schulz IM, Nomden C, Gillham C, McArdle O, Van Limbergen E, Janssen H, Hoskin P, Lowe G, Tharavichitkul E, Villafranca E, Mahantshetty U, Georg P, Kirchheiner K, Kirisits C, Tanderup K, Lindegaard JC. Image guided brachytherapy in locally advanced cervical cancer: Improved pelvic control and survival in RetroEMBRACE, a multicenter cohort study. Radiother Oncol. 2016 Sep;120(3):428-433. doi: 10.1016/j.radonc.2016.03.011. Epub 2016 Apr 29. PMID 27134181
- Fokdal L, Sturdza A, Mazeron R, Haie-Meder C, Tan LT, Gillham C, Segedin B, Jurgenliemk-Schultz I, Kirisits C, Hoskin P, Potter R, Lindegaard JC, Tanderup K. Image guided adaptive brachytherapy with combined intracavitary and interstitial technique improves the therapeutic ratio in locally advanced cervical cancer: Analysis from the retroEMBRACE study. Radiother Oncol. 2016 Sep;120(3):434-440. doi: 10.1016/j.radonc.2016.03.020. Epub 2016 Apr 21.