Compliance to Cervical Cancer Chemoradiation Guidelines: A Multicentric Implementation Audit and Resource Assessment Initiative of National Cancer Grid of India

NCT07290972 | Recruiting DMC

• 1 other identifier: TMC IEC III 900537
• Study Type: observational
• Target: 618
• Locations: 1 country
• Sites: 2

Brief Summary

This is a combination of retrospective and prospective observational study that will be performed across NCG and other participating centers to report compliance to chemoradiation for cervical cancer. This audit will include patients treated with standard of care treatment, in this case definitive or adjuvant radiation+/- concurrent chemotherapy will be included. Patients recruited in various institutions in prospective clinical trials will not be included. The participating centersthat agree to contribute data will include all registered cases over a 6-month period that have been diagnosed with cervical cancer wherein treatment is planned with radical dose radiation and/or concurrent chemotherapy. Centers that do not have retrospective data of the patients will contribute data of patients registered prospectively over 6 months. Furthermore, any cases referred to the institution for brachytherapy alone will also be included. As a first step member institutions that participated in guideline development process or provide an agreement to guidelines adherence will be audited. The project will be submitted in institutional ethics committees with memorandum of understanding for anonymized data sharing. Each of the co-investigators listed from contributing centers will be directly responsible for collecting data contribution and accuracy of data submitted. Those centres which cannot or do not want to participate will be requested to provide data on only compliance outcomes to treatment for at least of 5 consecutively patients diagnosed with cervical cancer wherein treatment is planned with radical dose radiation and /or concurrent chemotherapy over a period of 6 months.

Conditions

Cervical Cancer Screening; Gynecologic Cancers; Treatment Compliance; Chemoradiotherapy

Keywords

Cervical cancer; Cancer; Recurrence; Treatment; Compliance; Chemoradiotherapy

Outcome Measures

Primary Outcomes (1)

• report on institutional compliance to National Cancer Grid cervical cancer guidelines for chemo-radiation.

  To report praportion of patients with No deviation, Major \& Minor Deviation and unacceptable deviation for chemoradiation guidlines.

  3 Months

Secondary Outcomes (3)

• To report on factors impacting compliance to standard guidelines

  3years

• To report adequacy of infrastructural and manpower requirements for optimal treatment of cervical cancer in NCG centres and corresponding state of origin

  3 years

• To compute relative risk of suboptimal treatment for cervical cancer in reference to infrastructural and manpower deficits

  3 years

Study Arms (1)

Patients diagnosed with Cervical Cancer

Patients diagnosed with histologically proven cervical cancer wherein either radical, adjuvant or palliative radiation with or without concurrent or systemic chemotherapy planned.

Other: Not applicable- observational study

Interventions

Not applicable- observational study OTHER

Compliance to Cervical Cancer Chemoradiation treatment guidelines

Patients diagnosed with Cervical Cancer

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The participating centers that agree to contribute data will include all registered cases over a 6 month period that have been diagnosed with histologically proven cervical cancer wherein either radical, adjuvant or palliative radiation with or without concurrent or systemic chemotherapy is planned. Furthermore any cases referred to the institution for brachytherapy alone will also be included.

The participating centers that agree to contribute data will include all registered cases over a 6 month period that have been diagnosed with histologically proven cervical cancer wherein either radical, adjuvant or palliative radiation with or without concurrent or systemic chemotherapy is planned. Furthermore any cases referred to the institution for brachytherapy alone will also be included.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Tata Memorial Hospital: lead
• Post Graduate Institute of Medical Education and Research, Chandigarh: collaborator
• MNJ Institute of Oncology and Regional Cancer Center: collaborator
• Christian Medical College, Vellore, India: collaborator

Study Sites (2)

Tata Memorial Hospital

Mumbai, Maharashtra, 400012, India

RECRUITING

Tata Memorial Hospital

Mumbai, Maharashtra, 400012, India

RECRUITING

Related Publications (16)

• Dr. V. K. Srivastava, Dr Tanvir Kaur, Dr. S Shrisvastava () CONSENSUS DOCUMENT FOR THE MANAGEMENT OF CANCER CERVIX, Available at: https://www.icmr.nic.in > sites > default > files > reports > Cervix Cance (Accessed: 12th December 2019).

  BACKGROUND

• IAEA staffing estimator. http://nucleus.iaea.org/HHW/RadiationOncology/making the case for radiotherapy in your country/role of radiotherapy in cancer care/radiotherapy is a cost effective system which needs balance/index.html.

  BACKGROUND

• IPEM recommendations for the provision of physics services to radiotherapy. http://ipem.ac.uk/portals/0/documents/recommendations.

  BACKGROUND

• Budiharto T, Musat E, Poortmans P, Hurkmans C, Monti A, Bar-Deroma R, Bernstein Z, Tienhoven Gv, Collette L, Duclos F, Davis B, Aird E; EORTC Radiation Oncology Group. Profile of European radiotherapy departments contributing to the EORTC Radiation Oncology Group (ROG) in the 21st century. Radiother Oncol. 2008 Sep;88(3):403-10. doi: 10.1016/j.radonc.2008.05.013. Epub 2008 Jun 4.

  PMID: 18538427 BACKGROUND

• International Atomic Energy Agency. Planning national radiotherapy services: a practical tool. IAEA human health series number 14. Vienna International Atomic Energy Agency;2010. ISBN 978-92-0-1059 10-9.

  BACKGROUND

• Nandakumar A, Kishor Rath G, Chandra Kataki A, Poonamalle Bapsy P, Gupta PC, Gangadharan P, Mahajan RC, Nath Bandyopadhyay M, Kumaraswamy, Vallikad E, Visweswara RN, Selvaraj Roselind F, Sathishkumar K, Daniel Vijaykumar D, Jain A, Lakshminarayana Sudarshan K. Concurrent Chemoradiation for Cancer of the Cervix: Results of a Multi-Institutional Study From the Setting of a Developing Country (India). J Glob Oncol. 2015 Sep 23;1(1):11-22. doi: 10.1200/JGO.2015.000877. eCollection 2015 Oct.

  PMID: 28804767 BACKGROUND

• Grover S, Gudi S, Gandhi AK, Puri PM, Olson AC, Rodin D, Balogun O, Dhillon PK, Sharma DN, Rath GK, Shrivastava SK, Viswanathan AN, Mahantshetty U. Radiation Oncology in India: Challenges and Opportunities. Semin Radiat Oncol. 2017 Apr;27(2):158-163. doi: 10.1016/j.semradonc.2016.11.007. Epub 2016 Nov 14.

  PMID: 28325242 BACKGROUND

• Banerjee S, Mahantshetty U, Shrivastava S. Brachytherapy in India - a long road ahead. J Contemp Brachytherapy. 2014 Oct;6(3):331-5. doi: 10.5114/jcb.2014.45761. Epub 2014 Oct 6.

  PMID: 25337139 BACKGROUND

• Gandhi AK, Sharma DN, Julka PK, Rath GK. Attitude and practice of brachytherapy in India: a study based on the survey amongst attendees of Annual Meeting of Indian Brachytherapy Society. J Contemp Brachytherapy. 2015 Dec;7(6):462-8. doi: 10.5114/jcb.2015.55666. Epub 2015 Nov 17.

  PMID: 26816503 BACKGROUND

• Mittal P, Chopra S, Pant S, Mahantshetty U, Engineer R, Ghosh J, Gupta S, Ghadi Y, Menachery S, Swamidas J, Gurram L, Shrivastava SK. Standard Chemoradiation and Conventional Brachytherapy for Locally Advanced Cervical Cancer: Is It Still Applicable in the Era of Magnetic Resonance-Based Brachytherapy? J Glob Oncol. 2018 Jul;4:1-9. doi: 10.1200/JGO.18.00028.

  PMID: 30085892 BACKGROUND

• Mahantshetty U, Krishnatry R, Hande V, Jamema S, Ghadi Y, Engineer R, Chopra S, Gurram L, Deshpande D, Shrviastava S. Magnetic Resonance Image Guided Adaptive Brachytherapy in Locally Advanced Cervical Cancer: An Experience From a Tertiary Cancer Center in a Low and Middle Income Countries Setting. Int J Radiat Oncol Biol Phys. 2017 Nov 1;99(3):608-617. doi: 10.1016/j.ijrobp.2017.06.010. Epub 2017 Jun 20.

  PMID: 29280456 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

• 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

• Potter R, Tanderup K, Kirisits C, de Leeuw A, Kirchheiner K, Nout R, Tan LT, Haie-Meder C, Mahantshetty U, Segedin B, Hoskin P, Bruheim K, Rai B, Huang F, Van Limbergen E, Schmid M, Nesvacil N, Sturdza A, Fokdal L, Jensen NBK, Georg D, Assenholt M, Seppenwoolde Y, Nomden C, Fortin I, Chopra S, van der Heide U, Rumpold T, Lindegaard JC, Jurgenliemk-Schulz I; EMBRACE Collaborative Group. The EMBRACE II study: The outcome and prospect of two decades of evolution within the GEC-ESTRO GYN working group and the EMBRACE studies. Clin Transl Radiat Oncol. 2018 Jan 11;9:48-60. doi: 10.1016/j.ctro.2018.01.001. eCollection 2018 Feb.

  PMID: 29594251 BACKGROUND

• Gupta S, Maheshwari A, Parab P, Mahantshetty U, Hawaldar R, Sastri Chopra S, Kerkar R, Engineer R, Tongaonkar H, Ghosh J, Gulia S, Kumar N, Shylasree TS, Gawade R, Kembhavi Y, Gaikar M, Menon S, Thakur M, Shrivastava S, Badwe R. Neoadjuvant Chemotherapy Followed by Radical Surgery Versus Concomitant Chemotherapy and Radiotherapy in Patients With Stage IB2, IIA, or IIB Squamous Cervical Cancer: A Randomized Controlled Trial. J Clin Oncol. 2018 Jun 1;36(16):1548-1555. doi: 10.1200/JCO.2017.75.9985. Epub 2018 Feb 12.

  PMID: 29432076 BACKGROUND

• Chopra SJ, Mathew A, Maheshwari A, Bhatla N, Singh S, Rai B, Surappa ST, Ghosh J, Sharma D, Bhaumik J, Biswas M, Deodhar K, Popat P, Giri S, Mahantshetty U, Tongaonkar H, Billimaga R, Engineer R, Grover S, Pedicayil A, Bajpai J, Rekhi B, Alihari A, Babu G, Thangrajan R, Menon S, Shah S, Palled S, Kulkarni Y, Gulia S, Naidu L, Thakur M, Rangrajan V, Kerkar R, Gupta S, Shrivastava SK. National Cancer Grid of India Consensus Guidelines on the Management of Cervical Cancer. J Glob Oncol. 2018 Jul;4:1-15. doi: 10.1200/JGO.17.00152.

  PMID: 30085891 BACKGROUND

MeSH Terms

Conditions

Patient Compliance; Uterine Cervical Neoplasms; Neoplasms; Recurrence

Condition Hierarchy (Ancestors)

Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Dr. Supriya Chopra, MD

  ACTREC, Tata Memorial Centre, Navi Mumbai India

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr. Supriya Chopra, MD

CONTACT

9930958309; supriyasastri@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Target Duration: 3 Years
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Dr Supriya Sastri

Study Record Dates

• First Submitted: August 21, 2025
• First Posted: December 18, 2025
• Study Start: February 1, 2021
• Primary Completion: March 31, 2026
• Study Completion: March 31, 2026
• Last Updated: February 4, 2026

Record last verified: 2026-01

Locations

IN (2)