Radiation therapy with Image Guided Intensity Modulated Radiotherapy and standard radiation therapy after surgery in cervical cancer patients.

Phase III randomized controlled trial of Image Guided Intensity Modulated Radiotherapy (IG-IMRT) and Conventional Radiotherapy for late toxicity reduction reduction after postoperative radiotherapy in carcinoma cervix.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2010/091/002959

Enrollment

240

Registered

2011-01-19

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Tomotherapy arm: NA Control Intervention1: COnventional Radiotherapy: NA

Eligibility

Inclusion criteria

Inclusion criteria: 1.Histopathological diagnosis of carcinoma cervix with postoperative intermediate or high risk features. 2.Age > 18 years 3.Planned for Wertheim's hysterectomy or has already undergone simple hysterectomy and has no evidence of residual pelvic nodes on MRI/PET imaging +/_ confirmatory nodal biopsy. 4.No evidence of paraaortic nodal biopsy. 5.WIlling for specimen archiving in tumor tissue biorepository.

Exclusion criteria

Exclusion criteria: 1.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. 2.Rectal Polyps or extensive hemorroids causing bleeding.

Design outcomes

Primary

Measure	Time frame
Late Small Bowel ToxicityTimepoint: Not Available	—

Secondary

Measure	Time frame
1. Dose Volume Histogram correlates of late small bowel toxicity. 2. Preoperative translational imaging (multifunctional PET MRI) correlates of local and distant control. 3.Comparative Quality of LifeTimepoint: Not Applicable	—

Countries

India

Contacts

Public ContactDr Supriya Chopra

schopra@actrec.gov.in02227405000 extn 5546/5510

Outcome results