Intersphincteric Resection With or Without Intraoperative Radiation in Rectal Cancer (IDAVON)

• ClinicalTrials.gov Identifier: NCT03393234
• Recruitment Status: Unknown
• First Posted: January 8, 2018
• Last Update Posted: January 8, 2018
• Sponsor: Second Hospital of Jilin University
• Information provided by (Responsible Party): Second Hospital of Jilin University

Study Description

Brief Summary:

The purpose of this study was to research on the safety and feasibility of ISR combined with low energy X ray intra-operative radiotherapy for the patients with local advanced rectal cancer.

Condition or disease	Intervention/treatment	Phase
Rectal Cancer	Radiation: Interoperative radiation by INTRABEAM using low energy X-ray	Not Applicable

Detailed Description:

Inter-sphincteric resection (ISR) has become an increasingly popular optional surgical tool for the treatment of very low rectal cancer. Nowadays, preoperative criteria for Lap ISR were the patients whose diagnosed with clinical stages T1-2 and N0_1, which only a few patients with early stages can benefit from it. However, intra-operative radiotherapy with low energy X ray applied by Intrabeam is becoming an accepted radiotherapy technique for treatment of cancers. The purpose of this study was to research on the safety and feasibility of ISR combined with low energy X ray intra-operative radiotherapy for the patients with local advanced rectal cancer.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Masking Description: Patients will be assigned to two different groups and receive intraoperative radiation randomly. The care provider and investigator also don't know the concrete situation of the patients.
• Primary Purpose: Treatment
• Official Title: Study of Safety and Feasibility of the Intersphincteric Resection With or Without Intraoperative Radiation in Low Rectal Cancer
• Actual Study Start Date: June 1, 2017
• Estimated Primary Completion Date: January 1, 2022
• Estimated Study Completion Date: January 1, 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: A group; Patients who receive interphincteric resection (ISR) in this group will be given extra intraoperative radiation by INTRBEAM using low energy X-ray.	Radiation: Interoperative radiation by INTRABEAM using low energy X-ray; Intrabeam is a mobile Platform for Intraoperative Radiotherapy (IORT) produced by the ZEISS company in Germany.Interoperative radiation by INTRABEAM using low energy X-ray.The Intrabeam PRS appears to be a safe technique for delivering IORT in rectal cancer patients.
No Intervention: B group; Patients who only receive interphincteric resection (ISR) in this group without intraoperative radiation.

Outcome Measures

Primary Outcome Measures :

1. 3-year disease free survival [ Time Frame: 3 years ]
   Compare 3-year disease free survival in patients with resectable rectal cancer treated with or without radiation.

Secondary Outcome Measures :

1. local recurrence rate [ Time Frame: 1 years ]
   In our study, no matter whether distant metastases occurred, if there was the presence of any anastomotic, pelvic, or lateral node recurrences recorded by pathologic or clinical examination, we defined it as local recurrence.
2. R0 resection rate [ Time Frame: 1 years ]
   To calculate the radical resection rate.
3. sphincter muscle function [ Time Frame: 1 years ]
   Indicated by the anorectal manometry
4. anorectal manometry [ Time Frame: 1 years ]
   To measure the anus pressure to indirectly reflect the sphincter muscle function
5. predictive biomarkers [ Time Frame: 3 years ]
   Each follow-up, the biomarkers such as CEA,CA19-9 etc were recorded.
6. sexual function [ Time Frame: 1 years ]
   Investigated by the questionnaire including the International Index of Erectile dysfunction. (IIEF5)

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• those whom were preoperatively assessed to be in clinical stageT3 or has lymphatic metastasis by MRI or ultrasonic endoscopy;
• the lower edge of the tumor is away from the anal edge by less than 5 cm, or away from the dentate line by less than 3cm;
• in intra-operative separation, the lower edge of the tumor is below the plane of the levator ani muscle or the tumor is hard to separate;
• those in T4 stage and could be radically resected by intra-operative surgeon assessment;
• adequate preoperative sphincter function and continence; (vi)local spread restricted to the rectal wall or the IAS.
• absence of distant metastases.

Exclusion Criteria:

• clinical T4 tumors based on the Union for International Cancer Control UICC TNM classification (7th edition):
• infiltrating gross appearance of the tumors;
• poorly differentiated adenocarcinoma by biopsy specimens;
• a degree of preoperative incontinence.

Contacts and Locations

Contacts

Contact: Min Wang, M.D.; (+86)13074373336; jdeywangmin@163.com

Locations

China, Jilin

The Second Hospital of Jilin University; Recruiting

Changchun, Jilin, China, 130041

Contact: Min Wang, M.D. +86 13074373336 jdeywangmin@163.com

Sponsors and Collaborators

Second Hospital of Jilin University

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Wang M, Xue W, Zhao Z, Li Y, Wang X, Li T, Zou Y, Song X, Zhang M, Wang T, Yang J, Wang C, Wang S. Laparoscopic intersphincteric resection with intraoperative radiotherapy using low-energy X-rays for locally advanced ultra-low rectal cancer. World J Surg Oncol. 2018 Jul 7;16(1):133. doi: 10.1186/s12957-018-1430-6.

• Responsible Party: Second Hospital of Jilin University
• ClinicalTrials.gov Identifier: NCT03393234
• Other Study ID Numbers: ISR and IORT
• First Posted: January 8, 2018
• Last Update Posted: January 8, 2018
• Last Verified: January 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: When the investigators complete the study and publish our data.
• Supporting Materials: Study Protocol; Clinical Study Report (CSR)

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

Keywords provided by Second Hospital of Jilin University:

Ultra-low rectal cancer; Intersphincteric resection; IORT

Additional relevant MeSH terms:

Rectal Neoplasms; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases