Tomotherapy vs Conventional Radiation for Adjuvant Pelvic RT in Ca Cervix

NCT01279135 | Completed Phase 3 DMC

• 1 other identifier: Project 803
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

The study tests Tomtherapy based Image Guided Radiation against conventional radiation techniques for it's ability to reduce long term small bowel toxicity.

Conditions

Cancer Cervix

Keywords

IGRT,Postoperative, Cervix, Late toxicity, Bowel

Outcome Measures

Primary Outcomes (1)

• Late bowel toxicity ≥ Grade II

  Time to event and severity of late bowel toxicity are assessed

  Median follow up of 3 years

Secondary Outcomes (5)

• To identify small bowel dose volume characteristics that predict for ≥ Grade II late toxicity

  Median follow up of 3 years

• To evaluate acute toxicity difference in two study arms using CTCAE version 3.0

  Within 90 days

• Preoperative functional imaging features that predict for local and distant recurrence will be identified

  3 years after completion of accrual

• To compare quality of life between Tomotherapy vs conventional radiotherapy arm using EORTC QLQ C30

  3 years from completion of accrual

• To compare quality of life between Tomotherapy vs conventional radiotherapy arm using EORTC QLQ CX24

  3 years from completion of accrual

Study Arms (2)

Conventional RT

ACTIVE COMPARATOR

Patients in this arm will receive conventional radiation with or without chemotherapy

Radiation: Conventional Radiation

Tomotherapy based IGRT

EXPERIMENTAL

Patients in this arm will receive Tomotherapy based IGRT with or without chemotherapy

Radiation: Tomotherapy based IGRT

Interventions

Tomotherapy based IGRT RADIATION

Patients in this arm will received Tomotherapy based Image Guided Intensity Modulated Radiotherapy to a dose of 50 Gy/25 fractions/5 weeks

Tomotherapy based IGRT

Conventional Radiation RADIATION

Standard Pelvic Radiation 50 Gy/ 25 fractions over 5 weeks

Conventional RT

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histopathological diagnosis of carcinoma cervix with postoperative intermediate or high risk features.
• Age \>18 years.
• Planned for Wertheim's hysterectomy or has already undergone Wertheim's hysterectomy OR has undergone Simple Hysterectomy with no evidence of residual nodes on MRI/PET imaging+/- confirmatory nodal biopsy.
• No evidence of paraaortic nodal metastasis.

You may not qualify if:

• History of multiple previous abdominal surgeries placing patient at baseline high risk of bowel toxicity or any other medical condition with baseline bowel movement disorder.
• Rectal Polyps or extensive hemorrhoids.

Sponsors & Collaborators

• Tata Memorial Hospital: lead

Study Sites (1)

Advanced Centre for Treatment, Research and Education in Cancer, Tata Memorial Centre

Navi Mumbai, Maharashtra, 410210, India

Location

Related Publications (3)

• Chopra S, Engineer R, Mahantshetty U, Misra S, Phurailatpam R, Paul SN, Kannan S, Kerkar R, Maheshwari A, Shylasree Ts, Ghosh J, Gupta S, Thomas B, Singh S, Sharma S, Chilikuri S, Shrivastava SK. Protocol for a phase III randomised trial of image-guided intensity modulated radiotherapy (IG-IMRT) and conventional radiotherapy for late small bowel toxicity reduction after postoperative adjuvant radiation in Ca cervix. BMJ Open. 2012 Dec 12;2(6):e001896. doi: 10.1136/bmjopen-2012-001896. Print 2012.

  PMID: 23242243 BACKGROUND

• Supriya C, Nilesh R, Mayuri C, Sadhana K, Reena E, Tapas D, Lavanya G, Prachi M, Amita M, Shylasree TS, Shyam S, Sudeep G. Late toxicity within a Phase III clinical trial of IG-IMRT in cervix cancer (PARCER): Reanalysis with time weighted adverse event reporting (MOSES). Radiother Oncol. 2022 Dec;177:16-20. doi: 10.1016/j.radonc.2022.10.013. Epub 2022 Oct 18.

  PMID: 36270474 DERIVED

• Chinnachamy AN, Chopra S, Krishnatry R, Kannan S, Thomas B, Mahantshetty U, Engineer R, Shrivastava SK. Evaluation of interobserver and interscale agreement in assessing late bowel toxicity after pelvic radiation in patients with carcinoma of the cervix. Jpn J Clin Oncol. 2013 May;43(5):508-14. doi: 10.1093/jjco/hyt028. Epub 2013 Mar 20.

  PMID: 23515269 DERIVED

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 Chopra, MD,DNB

  ACTREC, Tata Memorial Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No masking. This is a open-label study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Patients enrolled are randomized to either conventional arm or tomotherapy arm for treatment after stratification according to type of surgery the patient underwent and the indication of chemotherapy along with radiation

Study Record Dates

• First Submitted: January 18, 2011
• First Posted: January 19, 2011
• Study Start: January 1, 2011
• Primary Completion: December 30, 2019
• Study Completion: May 5, 2020
• Last Updated: February 6, 2026

Record last verified: 2026-01

Locations

IN (1)