Tomotherapy vs Conventional Radiation for Adjuvant Pelvic RT in Ca Cervix

Tata Memorial Hospital300 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

300

Conditions

Cancer Cervix

Interventions

Conventional RadiationRADIATION

Standard Pelvic Radiation 50 Gy/ 25 fractions over 5 weeks

Tomotherapy based IGRTRADIATION

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

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

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

Navi Mumbai, Maharashtra, India

Outcomes

Primary Outcomes

Late bowel toxicity ≥ Grade II

Time to event and severity of late bowel toxicity are assessed

Time frame: Median follow up of 3 years

Secondary Outcomes

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

Data on dosimetric analysis of small bowel dose in reference to volume are collected in both arms and assessed for predicting dose prescription for ≥ grade II late bowel toxcity

Time frame: Median follow up of 3 years

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

Acute toxicity will be reported using CTCAE V.3.0. CTCAE forms will be filled before starting radiation, weekly during radiation treatment and on each scheduled follow-up. If any toxicity occurs at another time point additional forms will be filled to capture the same. Acute toxicity difference will be calculated between the two study arms.

Time frame: Within 90 days

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

Images acquired pre-operatively are analysed for features that predict local and distant recurrence.

Time frame: 3 years after completion of accrual

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

Assessment is done for all enrolled patients to compare the quality of life after treatment with tomotherapy and conventional radiation . EORTC QLQC30 module will be used for evaluating QOL of patients. QOL scoring will be done as per standard recommendations outlined in EORTC QLQ C30 scoring manual. All patients will undergo QOL evaluation at baseline, after treatment and at subsequent follow-up. Scale- Not at all-1 , A little Bit-2, Quite a bit-3, very much-4. 1 will be considered as better outcome \& 4 will be considered as worst outcome.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.