NCT03393234

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2017

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 1, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 8, 2018

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
Last Updated

January 8, 2018

Status Verified

January 1, 2018

Enrollment Period

4.6 years

First QC Date

January 1, 2018

Last Update Submit

January 5, 2018

Conditions

Rectal Cancer

Keywords

Ultra-low rectal cancerIntersphincteric resectionIORT

Outcome Measures

Primary Outcomes (1)

  • 3-year disease free survival

    Compare 3-year disease free survival in patients with resectable rectal cancer treated with or without radiation.

    3 years

Secondary Outcomes (6)

  • local recurrence rate

    1 years

  • R0 resection rate

    1 years

  • sphincter muscle function

    1 years

  • anorectal manometry

    1 years

  • predictive biomarkers

    3 years

  • +1 more secondary outcomes

Study Arms (2)

A group

EXPERIMENTAL

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

B group

NO INTERVENTION

Patients who only receive interphincteric resection (ISR) in this group without intraoperative radiation.

Interventions

Interoperative radiation by INTRABEAM using low energy X-rayRADIATION

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.

A group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Second Hospital of Jilin University

Changchun, Jilin, 130041, China

RECRUITING

Related Publications (1)

  • 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.

    PMID: 29981575DERIVED

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal Diseases

Central Study Contacts

Min Wang, M.D.

CONTACT

(+86)13074373336jdeywangmin@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 1, 2018

First Posted

January 8, 2018

Study Start

June 1, 2017

Primary Completion

January 1, 2022

Study Completion

January 1, 2022

Last Updated

January 8, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will share

When the investigators complete the study and publish our data.

Shared Documents
STUDY PROTOCOL, CSR

Locations

CN(1)