Single Application Brachytherapy in Cervical Cancer

NCT03110497 | Unknown DMC

• 2 other identifiers: TMH-1759REF/2017/03/013733
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Cervical Cancer

Keywords

Cervical cancer; Image guided Brachytherapy; single application

Outcome Measures

Primary Outcomes (1)

• Number of participants achieving specified dosimetric constraints

  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.

  1 year

Secondary Outcomes (3)

• Number of participants with adverse events as assessed by CTCAE v 4.0

  2 years

• Local control rate

  2 years

• Percentage Inter-fraction dose variation

  1 year

Study Arms (1)

Single application brachytherapy

EXPERIMENTAL

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.

Radiation: Single application multi-fraction brachytherapy

Interventions

Single application multi-fraction brachytherapy RADIATION

Single application brachytherapy procedure to deliver high dose rate fractions of 9Gy, 7Gy and 7Gy with 6-12 hours apart under strict image guidance

Single application brachytherapy

Eligibility Criteria

• Gender Eligibility Details: Study conducted for females with cervical cancer
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Tata Memorial Hospital: lead

Study Sites (1)

Tata Memorial Hospital

Mumbai, Maharashtra, 400012, India

RECRUITING

Related Publications (8)

• Tanderup 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 BACKGROUND

• Lindegaard 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 BACKGROUND

• Potter 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 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

• 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

• 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.

  PMID: 27113795 BACKGROUND

• Patel FD, Sharma SC, Negi PS, Ghoshal S, Gupta BD. Low dose rate vs. high dose rate brachytherapy in the treatment of carcinoma of the uterine cervix: a clinical trial. Int J Radiat Oncol Biol Phys. 1994 Jan 15;28(2):335-41. doi: 10.1016/0360-3016(94)90055-8.

  PMID: 8276647 BACKGROUND

• Shrivastava S DK, Mahantshetty U, Engineer R, Patil N, Deshpande D, Tongaonkar H Comparing Low-Dose-Rate andHigh-Dose-Rate Intracavitary Brachytherapy in Carcinoma Cervix: Results From a Randomized Controlled Study. . Int J Radiat Oncol Biol Phys 2006, 1; 66.

  BACKGROUND

Related Links

• EMBRACE Study

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

• Umesh Mahantshetty, MD, DNB

  Professor, Department of Radiation oncology, Tata memorial Centre, Mumbai

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Umesh Mahantshetty, MD, DNB

CONTACT

022 24177000; drumeshm@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Phase I/ Phase II single arm study

Study Record Dates

• First Submitted: March 24, 2017
• First Posted: April 12, 2017
• Study Start: September 17, 2017
• Primary Completion: April 17, 2019
• Study Completion: April 17, 2020
• Last Updated: November 7, 2018

Record last verified: 2018-01

Locations

IN (1)