Tomotherapy vs Conventional Radiation for Adjuvant Pelvic RT in Ca Cervix

Cancer Cervix Clinical Trial

— PARCER  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01279135
• Other study ID #: Project 803
• Status: Completed
• Phase: Phase 3
• Start date: January 1, 2011
• Est. completion date: January 31, 2020

Study information

• Verified date: June 2020
• Source: Tata Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: January 31, 2020
• Est. primary completion date: December 30, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer Cervix

Intervention

Radiation:
• Conventional Radiation
Standard Pelvic Radiation 50 Gy/ 25 fractions over 5 weeks
• 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

Locations

Country	Name	City	State
India	Advanced Centre for Treatment, Research and Education in Cancer, Tata Memorial Centre	Navi Mumbai	Maharashtra

Sponsors (1)

Lead Sponsor	Collaborator
Tata Memorial Hospital

Country where clinical trial is conducted

India, 

References & Publications (1)

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). pii: e001896. doi: 10.1136/bmjopen-2012-001896. Print 2012. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Late bowel toxicity = Grade II	Time to event and severity of late bowel toxicity are assessed	Median follow up of 3 years
Secondary	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	Median follow up of 3 years
Secondary	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.	Within 90 days
Secondary	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.	3 years after completion of accrual
Secondary	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.	3 years from completion of accrual
Secondary	To compare quality of life between Tomotherapy vs conventional radiotherapy arm using EORTC QLQ CX24	Assessment is done for all enrolled patients to compare the quality of life after treatment with tomotherapy and conventional radiation. EORTC QLQCX24 module will be used to assess disease-specific and treatment-specific aspects of QoL in patients with cervical cancer. CX24 QOL scoring will be done as per standard recommendations outlined in EORTC QLQ CX24 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.	3 years from completion of accrual

External Links

•   Radiation (3DCRT) Versus IGIMRT for Reducing Late Bowel Toxicity in Cervical Cancer (PARCER) (NCT01279135/CTRI2012/120349): Results of Interim Analyses