Tomotherapy vs Conventional Radiation for Adjuvant Pelvic RT in Ca Cervix

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-01

Study Completion Date

2020-01-31

Brief Summary

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

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Detailed Description

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Postoperative pelvic radiotherapy (+/- chemotherapy) leads to reduction in the risk of local recurrence and improves progression free survival (PFS) in patients with post-operative intermediate and high risk factors following Wertheim's hysterectomy. However, adjuvant external beam radiotherapy and vaginal cuff brachytherapy increase the risk of small bowel toxicity such that patients undergoing external beam pelvic radiotherapy and vaginal cuff brachytherapy may have 15-18% incidence of late RTOG ≥ grade II small bowel toxicity. Phase II studies using new techniques like Intensity Modulated Radiotherapy (IMRT) have reported up to 50% reduction in small bowel doses with up to 30% reduction in ≥ grade II acute toxicity. However, there is no randomized data demonstrating the benefit of highly specific and conformal techniques like image guided (IG)-IMRT in reducing radiation induced small bowel toxicity in patients with cervical cancers. The present study is being proposed to test if use of IG-IMRT with Tomotherapy is associated with reduced small bowel late toxicity

Conditions

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Cancer Cervix

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

No masking. This is a open-label study.

Study Groups

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Conventional RT

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

Group Type ACTIVE_COMPARATOR

Conventional Radiation

Intervention Type RADIATION

Standard Pelvic Radiation 50 Gy/ 25 fractions over 5 weeks

Tomotherapy based IGRT

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

Group Type EXPERIMENTAL

Tomotherapy based IGRT

Intervention Type RADIATION

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

Interventions

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Conventional Radiation

Standard Pelvic Radiation 50 Gy/ 25 fractions over 5 weeks

Intervention Type RADIATION

Tomotherapy based IGRT

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

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No