Clinical trial NCT01279135: Tomotherapy vs Conventional Radiation for Adjuvant Pelvic RT in Ca Cervix
Official title: Phase III Randomized Trial of Image Guided Intensity Modulated Radiotherapy (IG-IMRT) and Conventional Radiotherapy for Late Toxicity Reduction After Postoperative Radiotherapy in Ca Cervix.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cancer Cervix
Keywords: IGRT,Postoperative, Cervix, Late toxicity, Bowel
Lead sponsor: Tata Memorial Hospital
Sponsor class: OTHER_GOV
First posted: 2011-01-19
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

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.

Detailed description: 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

Eligibility criteria: 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.

Primary outcomes:
measure: Late bowel toxicity ≥ Grade II
timeFrame: Median follow up of 3 years
Secondary outcomes:
measure: To identify small bowel dose volume characteristics that predict for ≥ Grade II late toxicity
timeFrame: Median follow up of 3 years
measure: To evaluate acute toxicity difference in two study arms using CTCAE version 3.0
timeFrame: Within 90 days
measure: Preoperative functional imaging features that predict for local and distant recurrence will be identified
timeFrame: 3 years after completion of accrual
measure: To compare quality of life between Tomotherapy vs conventional radiotherapy arm using EORTC QLQ C30
timeFrame: 3 years from completion of accrual
measure: To compare quality of life between Tomotherapy vs conventional radiotherapy arm using EORTC QLQ CX24
timeFrame: 3 years from completion of accrual
Other outcomes:
Locations:
city: Navi Mumbai
country: India
facility: Advanced Centre for Treatment, Research and Education in Cancer, Tata Memorial Centre
state: Maharashtra
Study officials:
affiliation: ACTREC, Tata Memorial Centre
name: Supriya Chopra, MD,DNB
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.