Cervical CancerCOMBAT-CxNCT03005743
Image Based Brachytherapy in Locally Advanced Cervical Cancers - a Randomized Controlled Trial
A study testing Magnetic Resonance Image based Brachytherapy and Conventional Radiograph based Brachytherapy in people with Cervical Cancer, run by Tata Memorial Hospital at 1 site in India.
Trial summary
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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- Magnetic Resonance Image based Brachytherapy and Conventional Radiograph based Brachytherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,050 participants
- Where
- 1 siteIndia
- Study dates
- Dec 2016to 28 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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)
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.
Read the detailed description
The standard treatment of locally advanced cervical cancer is radio-chemotherapy including external beam radiotherapy (EBRT), brachytherapy (BT) and concomitant chemotherapy with weekly Cisplatin. While image based conformal EBRT is routinely used, prescription and reporting of BT is still based on specific dose points which are conventional radiography based surrogates for tumour (Manchester point A prescription point) and normal tissues [International commission on Radiation Units and Measurements (ICRU) Bladder and Rectum point]. This conventional radiography based planning has been adopted universally for ease of delivering safe doses with reasonably good local control rates (stage IIB - 85%; Stage IIIB - 65%) and acceptable acute and late toxicities (</=10% grade III/IV). Thus, for several decades conventional radiography based prescription has been standard of care universally. But these conventional radiography based surrogates have been proved to be only rough estimates and do not always correlate in 3 dimensional (3D) anatomy for neither tumour nor normal tissues for actual doses delivered and outcomes in terms of control rates and toxicities respectively. Several studies have been published demonstrating limitations and criticizing this point based treatments. In 2006, a working group from Groupe Européen de Curiethérapie- European Society for Therapeutic Radiology and Oncology (GEC-ESTRO) has published recommendations on contouring of tumour target and organs at risk (OAR) as well as on dose volume parameters to be reported for image guided BT in definitive radiotherapy for locally advanced cervical cancer. These recommendations are mainly derived from retrospective single institution experience with Magnetic Resonance (MR) image based Intracavitary Brachytherapy (ICBT). The major advantage of this technique is the possibility to conform the dose given by BT with regard to volume (3D) for both tumour and critical normal tissues (bladder, rectum, sigmoid mainly). Thus, by repetitive imaging performed before each BT treatment it is possible to adapt dose given as per the anatomy of each individual patient taking into account not only the position of OAR but also the tumour regression which often is obtained by preceding EBRT and chemotherapy. Clinical Outcome data from Vienna, Paris and Mumbai have shown potential in improved local control rates with acceptable toxicities so far. Prospectively treated more than 100 patients with image based brachytherapy from Vienna Group have shown improved local control rates across all stages with decreased toxicity on comparisons with historical series of patients treated with Conventional Radiography based BT [13-19]. Also, a phase II multicentre intercontinental study using MR Image Based Brachytherapy (EMBRACE: European study on MRI-guided Brachytherapy in Locally Advanced Cervical Cancer) has been implemented and tested in various centres across the world including Tata Memorial Hospital, Mumbai. Over 600 patients have been recruited in the study so far. Based on the experience collected so far, the image based BT approach is expected to have a major impact on the clinical outcome for II B and III B (increase in local control rates by 10-20%) with concomitant decrease in the rates of late normal tissue toxicity (<5% Grade ¾), as compared to historical results for point based conventional treatment prescriptions [20].
EMBRACE is a study on MRI guided brachytherapy (BT) in locally advanced cervical cancer. Today point-based two-dimensional BT is most often used for definitive radiotherapy in cervical cancer. However, MRI guided Image Based brachytherapy is increasingly being used in several centres, and the results reported so far are very promising. The major advantage of this technique is the possibility to conform the dose given by BT with regard to both volume (3D) and time (4D). Thus, by repetitive imaging performed before each BT implant it is possible to adapt the dose given by BT to the anatomy of each individual patient taking into account not only the position of organs at risk but also the tumour regression which often is obtained by preceding external beam radiotherapy and chemotherapy. Based on the experience collected so far, the image based BT approach significantly improves the dose-volume histogram (DVH) parameters and the improved dose delivered seems to have a major impact on the clinical outcome with a concomitant decrease in the rates of both local failure and morbidity. Preliminary results of ongoing studies including RETRO EMBRACE (600 patients - retrospective multicentric analysis) and EMBRACE (1000 patients recruited so far prospectively multicentric) also suggest excellent local control rates \& minimal clinical significant toxicities.
Hypothesis: The clinical outcome of radical radiation therapy including Conventional radiography based brachytherapy for International Federation of Gynecology and Obstetrics (FIGO) Stage IIB and IIIB reported in historical series is 75% and 55% local control rates and grade ¾ rectal / bladder toxicities of 10-15%. With the addition of concomitant cisplatin chemotherapy there is an additional local control benefit of 5-10% and potentially increase in late toxicities (no substantial evidence for toxicities reported so far). With the MR Image Based Brachytherapy approach, mono-institutional series and phase II multicentric international study, the results reported so far show an improvement in local control rates to 96% and 86% for IIB and IIIB respectively and late toxicities <5% reported so far. We propose this randomized control study to test the following hypothesis: With the use of MR Image Based Brachytherapy (Study Arm) in locally advanced cervical cancers (Stratified for Stage IIB and IIIB), there will be an absolute increase in local control rates by 10% and reduction in late rectal and bladder toxicities by 5% - 10% as compared to the Conventional radiography based ICBT. Thus, for demonstrating absolute local control benefit of 10% in Stages IIB (85% to 95%) and Stage IIIB (65% to 75%) a total of 1050 patients (350 patients with Stage IIB and 650 patients with stage IIB respectively) will be accrued.
- Conditions
- Cervical Cancer
- Being tested
- Magnetic Resonance Image based Brachytherapy, Conventional Radiograph based Brachytherapy
- Keywords
- Cervical cancer, Brachytherapy, Conventional planning, MR based Brachytherapy
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Resonance Image based BrachytherapyRadiation
MRI based BT prescription will be in accordance to the GEC-ESTRO guidelines [Intention will be to treat the whole cervix and the remaining residual tumour tissue at the primary site at the time of BT (high risk-clinical target volume) to a dose level analogue to the dose level previously prescribed for point-A]
Conventional Radiograph based BrachytherapyRadiation
The standard conventional radiography based prescription will be according to Manchester system Point A and bladder \& rectum ICRU point dose constraints
| Study group | Role | What they receive |
|---|---|---|
| MR based BT | Experimental | Magnetic Resonance Image based Brachytherapy Receives: Radiation: Magnetic Resonance Image based Brachytherapy |
| Conventional BT | Other | Conventional Radiograph based Brachytherapy Receives: Radiation: Conventional Radiograph based Brachytherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local control
Absolute benefit in local control rates by 10% for stages FIGO IIB and IIIB
Measured: 2 years
Secondary outcomes (7)
Late toxicities
Reduction in grade 3 and grade 4 (CTCAE) late toxicities from 10% to 5% (by 50%)
Measured: 2 years
Pelvic control rates
Measured: 2 years
Distant failure rates
Measured: 2 years
Progression free & cause specific survival
Measured: 2 years
Overall survival
Measured: 2 years
Quality of life questionnaire EORTC QLQ C30
Measured: 2 years
Quality life questionnaire EORTC QLQ CX24
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2016 (estimated)
- Study startDec 2016
- Primary completion28 May 2025
- Study completion28 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,050 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tata Memorial Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Supriya Sastri (chopra), Tata Memorial Centre
- Investigators
- Supriya Sastri (Chopra), MD, Principal investigator, Professor, Department of Radiation Oncology, Tata memorial Hospital, Mumbai 400012
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03005743
- Sponsor's protocol ID
- TMH-1587
- Acronym
- COMBAT-Cx
- Status last verified
- Feb 2026
- First submitted
- 21 Dec 2016
- Last updated
- 23 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Perez 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.
PubMed 9607346Chemoradiotherapy 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.
PubMed 20091664Vale 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.
PubMed 16229878Green 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.
PubMed 16034873Kirwan 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.
PubMed 13129628Viswanathan 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.
PubMed 22265437Takenaka 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.
PubMed 22843369Dolezel M, Odrazka K, Vanasek J, Kohlova T, Kroulik T, Kudelka K, Spitzer D, Mrklovsky M, Tichy M, Zizka J, Jalcova L. MRI-based pre-planning in patients with cervical cancer treated with three-dimensional brachytherapy. Br J Radiol. 2011 Sep;84(1005):850-6. doi: 10.1259/bjr/75446993.
PubMed 21849368Haie-Meder C, Potter R, Van Limbergen E, Briot E, De Brabandere M, Dimopoulos J, Dumas I, Hellebust TP, Kirisits C, Lang S, Muschitz S, Nevinson J, Nulens A, Petrow P, Wachter-Gerstner N; Gynaecological (GYN) GEC-ESTRO Working Group. Recommendations from Gynaecological (GYN) GEC-ESTRO Working Group (I): concepts and terms in 3D image based 3D treatment planning in cervix cancer brachytherapy with emphasis on MRI assessment of GTV and CTV. Radiother Oncol. 2005 Mar;74(3):235-45. doi: 10.1016/j.radonc.2004.12.015.
PubMed 15763303Potter R, Haie-Meder C, Van Limbergen E, Barillot I, De Brabandere M, Dimopoulos J, Dumas I, Erickson B, Lang S, Nulens A, Petrow P, Rownd J, Kirisits C; GEC ESTRO Working Group. Recommendations from gynaecological (GYN) GEC ESTRO working group (II): concepts and terms in 3D image-based treatment planning in cervix cancer brachytherapy-3D dose volume parameters and aspects of 3D image-based anatomy, radiation physics, radiobiology. Radiother Oncol. 2006 Jan;78(1):67-77. doi: 10.1016/j.radonc.2005.11.014. Epub 2006 Jan 5.
PubMed 16403584Potter 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.
PubMed 21821305Mahantshetty U, Swamidas J, Khanna N, Engineer R, Merchant NH, Deshpande DD, Shrivastava S. Reporting and validation of gynaecological Groupe Euopeen de Curietherapie European Society for Therapeutic Radiology and Oncology (ESTRO) brachytherapy recommendations for MR image-based dose volume parameters and clinical outcome with high dose-rate brachytherapy in cervical cancers: a single-institution initial experience. Int J Gynecol Cancer. 2011 Aug;21(6):1110-6. doi: 10.1097/IGC.0b013e31821caa55.
PubMed 21633296Yoshida K, Yamazaki H, Takenaka T, Kotsuma T, Yoshida M, Furuya S, Tanaka E, Uegaki T, Kuriyama K, Matsumoto H, Yamada S, Ban C. A dose-volume analysis of magnetic resonance imaging-aided high-dose-rate image-based interstitial brachytherapy for uterine cervical cancer. Int J Radiat Oncol Biol Phys. 2010 Jul 1;77(3):765-72. doi: 10.1016/j.ijrobp.2009.05.027. Epub 2009 Oct 14.
PubMed 19836165Kotsuma T, Yoshida K, Yamazaki H, Takenaka T, Konishi K, Isohashi F, Koizumi M, Tanaka E, Yoshioka Y. Preliminary results of magnetic resonance imaging-aided high-dose-rate interstitial brachytherapy for recurrent uterine carcinoma after curative surgery. J Radiat Res. 2011;52(3):329-34. doi: 10.1269/jrr.10172. Epub 2011 Mar 31.
PubMed 21467737Beriwal S, Kannan N, Kim H, Houser C, Mogus R, Sukumvanich P, Olawaiye A, Richard S, Kelley JL, Edwards RP, Krivak TC. Three-dimensional high dose rate intracavitary image-guided brachytherapy for the treatment of cervical cancer using a hybrid magnetic resonance imaging/computed tomography approach: feasibility and early results. Clin Oncol (R Coll Radiol). 2011 Dec;23(10):685-90. doi: 10.1016/j.clon.2011.08.007. Epub 2011 Sep 9.
PubMed 21908180
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT03005743
- Acronym / sponsor ID
- COMBAT-Cx / TMH-1587
- Conditions
- Cervical Cancer
- Keywords
- Cervical cancer, Brachytherapy, Conventional planning, MR based Brachytherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,050 participants (estimated)
- Lead sponsor
- Tata Memorial HospitalOther government
- Study start
- Dec 2016 (actual)
- Primary completion
- 28 May 2025 (actual)
- Study completion
- 28 May 2025 (actual)
- First posted
- 29 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The standard treatment of locally advanced cervical cancer is radio-chemotherapy including external beam radiotherapy (EBRT), brachytherapy (BT) and concomitant chemotherapy with weekly Cisplatin. While image based conformal EBRT is routinely used, prescription and reporting of BT is still based on specific dose points which are conventional radiography based surrogates for tumour (Manchester point A prescription point) and normal tissues [International commission on Radiation Units and Measurements (ICRU) Bladder and Rectum point]. This conventional radiography based planning has been adopted universally for ease of delivering safe doses with reasonably good local control rates (stage IIB - 85%; Stage IIIB - 65%) and acceptable acute and late toxicities (</=10% grade III/IV). Thus, for several decades conventional radiography based prescription has been standard of care universally. But these conventional radiography based surrogates have been proved to be only rough estimates and do not always correlate in 3 dimensional (3D) anatomy for neither tumour nor normal tissues for actual doses delivered and outcomes in terms of control rates and toxicities respectively. Several studies have been published demonstrating limitations and criticizing this point based treatments. In 2006, a working group from Groupe Européen de Curiethérapie- European Society for Therapeutic Radiology and Oncology (GEC-ESTRO) has published recommendations on contouring of tumour target and organs at risk (OAR) as well as on dose volume parameters to be reported for image guided BT in definitive radiotherapy for locally advanced cervical cancer. These recommendations are mainly derived from retrospective single institution experience with Magnetic Resonance (MR) image based Intracavitary Brachytherapy (ICBT). The major advantage of this technique is the possibility to conform the dose given by BT with regard to volume (3D) for both tumour and critical normal tissues (bladder, rectum, sigmoid mainly). Thus, by repetitive imaging performed before each BT treatment it is possible to adapt dose given as per the anatomy of each individual patient taking into account not only the position of OAR but also the tumour regression which often is obtained by preceding EBRT and chemotherapy. Clinical Outcome data from Vienna, Paris and Mumbai have shown potential in improved local control rates with acceptable toxicities so far. Prospectively treated more than 100 patients with image based brachytherapy from Vienna Group have shown improved local control rates across all stages with decreased toxicity on comparisons with historical series of patients treated with Conventional Radiography based BT [13-19]. Also, a phase II multicentre intercontinental study using MR Image Based Brachytherapy (EMBRACE: European study on MRI-guided Brachytherapy in Locally Advanced Cervical Cancer) has been implemented and tested in various centres across the world including Tata Memorial Hospital, Mumbai. Over 600 patients have been recruited in the study so far. Based on the experience collected so far, the image based BT approach is expected to have a major impact on the clinical outcome for II B and III B (increase in local control rates by 10-20%) with concomitant decrease in the rates of late normal tissue toxicity (<5% Grade ¾), as compared to historical results for point based conventional treatment prescriptions [20].
EMBRACE is a study on MRI guided brachytherapy (BT) in locally advanced cervical cancer. Today point-based two-dimensional BT is most often used for definitive radiotherapy in cervical cancer. However, MRI guided Image Based brachytherapy is increasingly being used in several centres, and the results reported so far are very promising. The major advantage of this technique is the possibility to conform the dose given by BT with regard to both volume (3D) and time (4D). Thus, by repetitive imaging performed before each BT implant it is possible to adapt the dose given by BT to the anatomy of each individual patient taking into account not only the position of organs at risk but also the tumour regression which often is obtained by preceding external beam radiotherapy and chemotherapy. Based on the experience collected so far, the image based BT approach significantly improves the dose-volume histogram (DVH) parameters and the improved dose delivered seems to have a major impact on the clinical outcome with a concomitant decrease in the rates of both local failure and morbidity. Preliminary results of ongoing studies including RETRO EMBRACE (600 patients - retrospective multicentric analysis) and EMBRACE (1000 patients recruited so far prospectively multicentric) also suggest excellent local control rates \& minimal clinical significant toxicities.
Hypothesis: The clinical outcome of radical radiation therapy including Conventional radiography based brachytherapy for International Federation of Gynecology and Obstetrics (FIGO) Stage IIB and IIIB reported in historical series is 75% and 55% local control rates and grade ¾ rectal / bladder toxicities of 10-15%. With the addition of concomitant cisplatin chemotherapy there is an additional local control benefit of 5-10% and potentially increase in late toxicities (no substantial evidence for toxicities reported so far). With the MR Image Based Brachytherapy approach, mono-institutional series and phase II multicentric international study, the results reported so far show an improvement in local control rates to 96% and 86% for IIB and IIIB respectively and late toxicities <5% reported so far. We propose this randomized control study to test the following hypothesis: With the use of MR Image Based Brachytherapy (Study Arm) in locally advanced cervical cancers (Stratified for Stage IIB and IIIB), there will be an absolute increase in local control rates by 10% and reduction in late rectal and bladder toxicities by 5% - 10% as compared to the Conventional radiography based ICBT. Thus, for demonstrating absolute local control benefit of 10% in Stages IIB (85% to 95%) and Stage IIIB (65% to 75%) a total of 1050 patients (350 patients with Stage IIB and 650 patients with stage IIB respectively) will be accrued.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MR based BT | Experimental | Radiation: Magnetic Resonance Image based BrachytherapyMagnetic Resonance Image based Brachytherapy |
| Conventional BT | Other | Radiation: Conventional Radiograph based BrachytherapyConventional Radiograph based Brachytherapy |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnetic Resonance Image based BrachytherapyMRI based BT prescription will be in accordance to the GEC-ESTRO guidelines [Intention will be to treat the whole cervix and the remaining residual tumour tissue at the primary site at the time of BT (high risk-clinical target volume) to a dose level analogue to the dose level previously prescribed for point-A] | Radiation | MR based BT |
| Conventional Radiograph based BrachytherapyThe standard conventional radiography based prescription will be according to Manchester system Point A and bladder \& rectum ICRU point dose constraints | Radiation | Conventional BT |
Primary outcome
Local control
Time frame: 2 years
Absolute benefit in local control rates by 10% for stages FIGO IIB and IIIB
7 secondary outcomes
Late toxicities
Time frame: 2 years
Pelvic control rates
Time frame: 2 years
Distant failure rates
Time frame: 2 years
Progression free & cause specific survival
Time frame: 2 years
Overall survival
Time frame: 2 years
Quality of life questionnaire EORTC QLQ C30
Time frame: 2 years
Quality life questionnaire EORTC QLQ CX24
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2026.
- Background: PubMed 9607346Perez 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.
- Background: PubMed 20091664Chemoradiotherapy 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.
- Background: PubMed 16229878Vale 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.
- Background: PubMed 16034873Green 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.
- Background: PubMed 13129628Kirwan 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.
- Background: PubMed 22265437Viswanathan 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.
- Background: PubMed 22843369Takenaka 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.
- Background: PubMed 21849368Dolezel M, Odrazka K, Vanasek J, Kohlova T, Kroulik T, Kudelka K, Spitzer D, Mrklovsky M, Tichy M, Zizka J, Jalcova L. MRI-based pre-planning in patients with cervical cancer treated with three-dimensional brachytherapy. Br J Radiol. 2011 Sep;84(1005):850-6. doi: 10.1259/bjr/75446993.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Supriya Sastri (Chopra), MD principal investigator
Professor, Department of Radiation Oncology, Tata memorial Hospital, Mumbai 400012
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnetic Resonance Image based Brachytherapy and Conventional Radiograph based Brachytherapy in people with Cervical Cancer, run by Tata Memorial Hospital at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local control (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03005743, which also lists 21 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2026.