Image Based Brachytherapy in Locally Advanced Cervical Cancers - a Randomized Controlled Trial

NCT03005743 | Completed DMC

• 1 other identifier: TMH-1587
• Study Type: interventional
• Target: 1,050
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cervical Cancer

Keywords

Cervical cancer; Brachytherapy; Conventional planning; MR based Brachytherapy

Outcome Measures

Primary Outcomes (1)

• Local control

  Absolute benefit in local control rates by 10% for stages FIGO IIB and IIIB

  2 years

Secondary Outcomes (7)

• Late toxicities

  2 years

• Pelvic control rates

  2 years

• Distant failure rates

  2 years

• Progression free & cause specific survival

  2 years

• Overall survival

  2 years

Study Arms (2)

MR based BT

EXPERIMENTAL

Magnetic Resonance Image based Brachytherapy

Radiation: Magnetic Resonance Image based Brachytherapy

Conventional BT

OTHER

Conventional Radiograph based Brachytherapy

Radiation: Conventional Radiograph based Brachytherapy

Interventions

Magnetic Resonance Image based Brachytherapy RADIATION

MRI based BT prescription will be in accordance to the GEC-ESTRO guidelines \[Intention will be to treat the whole cervix and the remaining residual tumour tissue at the primary site at the time of BT (high risk-clinical target volume) to a dose level analogue to the dose level previously prescribed for point-A\]

MR based BT

Conventional Radiograph based Brachytherapy RADIATION

The standard conventional radiography based prescription will be according to Manchester system Point A and bladder \& rectum ICRU point dose constraints

Conventional BT

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), 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 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tata Memorial Hospital: lead

Study Sites (1)

Tata Memorial Hospital

Mumbai, Maharashtra, 400012, India

Location

Related Publications (21)

• 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.

  PMID: 9607346 BACKGROUND

• Chemoradiotherapy 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 BACKGROUND

• Vale 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 BACKGROUND

• Green 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 BACKGROUND

• Kirwan 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 BACKGROUND

• Viswanathan 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 BACKGROUND

• Takenaka 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.

  PMID: 22843369 BACKGROUND

• Dolezel 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.

  PMID: 21849368 BACKGROUND

• Haie-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.

  PMID: 15763303 BACKGROUND

• Potter 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.

  PMID: 16403584 BACKGROUND

• Potter 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 BACKGROUND

• Mahantshetty 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.

  PMID: 21633296 BACKGROUND

• Yoshida 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.

  PMID: 19836165 BACKGROUND

• Kotsuma 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.

  PMID: 21467737 BACKGROUND

• Beriwal 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.

  PMID: 21908180 BACKGROUND

• Mahantshetty U, Swamidas J, Khanna N, Engineer R, Merchant NH, Shrivastava S. Magnetic resonance image-based dose volume parameters and clinical outcome with high dose rate brachytherapy in cervical cancers--a validation of GYN GEC-ESTRO brachytherapy recommendations. Clin Oncol (R Coll Radiol). 2011 Jun;23(5):376-7. doi: 10.1016/j.clon.2011.02.006. Epub 2011 Mar 5. No abstract available.

  PMID: 21377847 BACKGROUND

• Haie-Meder C, Chargari C, Rey A, Dumas I, Morice P, Magne N. MRI-based low dose-rate brachytherapy experience in locally advanced cervical cancer patients initially treated by concomitant chemoradiotherapy. Radiother Oncol. 2010 Aug;96(2):161-5. doi: 10.1016/j.radonc.2010.04.015.

  PMID: 20655120 BACKGROUND

• Schmid MP, Kirisits C, Nesvacil N, Dimopoulos JC, Berger D, Potter R. Local recurrences in cervical cancer patients in the setting of image-guided brachytherapy: a comparison of spatial dose distribution within a matched-pair analysis. Radiother Oncol. 2011 Sep;100(3):468-72. doi: 10.1016/j.radonc.2011.08.014. Epub 2011 Sep 14.

  PMID: 21924510 BACKGROUND

• Fidarova EF, Berger D, Schussler S, Dimopoulos J, Kirisits C, Georg P, Bachtiary B, Potter R. Dose volume parameter D2cc does not correlate with vaginal side effects in individual patients with cervical cancer treated within a defined treatment protocol with very high brachytherapy doses. Radiother Oncol. 2010 Oct;97(1):76-9. doi: 10.1016/j.radonc.2010.05.005. Epub 2010 Jun 17.

  PMID: 20561694 BACKGROUND

• Sturdza 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 BACKGROUND

• Prescribing, Recording, and Reporting Brachytherapy for Cancer of the Cervix. J ICRU. 2013 Apr;13(1-2):NP. doi: 10.1093/jicru/ndw027. No abstract available.

  PMID: 27335496 BACKGROUND

MeSH Terms

Conditions

Uterine Cervical Neoplasms

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

Study Officials

• Supriya Sastri (Chopra), MD

  Professor, Department of Radiation Oncology, Tata memorial Hospital, Mumbai 400012

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Radiation Oncology, ACTREC TATA Memorial Centre Mumbai 410210

Study Record Dates

• First Submitted: December 21, 2016
• First Posted: December 29, 2016
• Study Start: December 1, 2016
• Primary Completion: May 28, 2025
• Study Completion: May 28, 2025
• Last Updated: February 23, 2026

Record last verified: 2026-02

Locations

IN (1)