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

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

Tracking Information
First Submitted Date  ICMJE January 1, 2018
First Posted Date  ICMJE January 8, 2018
Last Update Posted Date January 8, 2018
Actual Study Start Date  ICMJE June 1, 2017
Estimated Primary Completion Date January 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 5, 2018)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: January 5, 2018)
  • 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.
  • R0 resection rate [ Time Frame: 1 years ]
    To calculate the radical resection rate.
  • sphincter muscle function [ Time Frame: 1 years ]
    Indicated by the anorectal manometry
  • anorectal manometry [ Time Frame: 1 years ]
    To measure the anus pressure to indirectly reflect the sphincter muscle function
  • predictive biomarkers [ Time Frame: 3 years ]
    Each follow-up, the biomarkers such as CEA,CA19-9 etc were recorded.
  • sexual function [ Time Frame: 1 years ]
    Investigated by the questionnaire including the International Index of Erectile dysfunction. (IIEF5)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intersphincteric Resection With or Without Intraoperative Radiation in Rectal Cancer
Official Title  ICMJE Study of Safety and Feasibility of the Intersphincteric Resection With or Without Intraoperative Radiation in Low Rectal Cancer
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Rectal Cancer
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.
    Intervention: Radiation: Interoperative radiation by INTRABEAM using low energy X-ray
  • No Intervention: B group
    Patients who only receive interphincteric resection (ISR) in this group without intraoperative radiation.
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 5, 2018)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 1, 2022
Estimated Primary Completion Date January 1, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Min Wang, M.D. (+86)13074373336 jdeywangmin@163.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03393234
Other Study ID Numbers  ICMJE ISR and IORT
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: When the investigators complete the study and publish our data.
Supporting Materials: Study Protocol
Supporting Materials: Clinical Study Report (CSR)
Responsible Party Second Hospital of Jilin University
Study Sponsor  ICMJE Second Hospital of Jilin University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Second Hospital of Jilin University
Verification Date January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP