NCT03209336

Brief Summary

To study the application of Intersphincteric Resection（ISR）combined with intraoperative radiation therapy(IORT) for ultra-low rectal cancer,and to broaden the surgical indications of Intersphincteric Resection（ISR. The study is aimed to assess the postoperative acute complication and the short-term acute efficacy on the patients with middle and low rectal cancer by treated with intraoperative radiotherapy,especially those with peritoneal inversion 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 Jan 2015

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

January 1, 2015

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

June 30, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 6, 2017

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2020

Completed
Last Updated

July 6, 2017

Status Verified

July 1, 2017

Enrollment Period

6 years

First QC Date

June 30, 2017

Last Update Submit

July 5, 2017

Conditions

Rectal Cancer

Keywords

Ultra-low rectal cancerIntersphincteric resectionIORT

Outcome Measures

Primary Outcomes (2)

  • Decide and record the region of radiotherapy

    The operator will confirm and record the range of intrabeam after removal of tumor such as the length and height to modify the dose and the time of intrabeam.

    Intraoperation

  • The basic information and medical history achieved (questionnaire)

    Investigators will take a overall information about the patients including the physical condition,history of present illness,family genetic history etc;Then the information will be recorded in a format to develop a statistic analysis.

    baseline

Secondary Outcomes (2)

  • Major Adverse Events

    1 year after operation

  • The short-term complications

    1 year after operation

Study Arms (2)

A group

EXPERIMENTAL

Colorectal cancer patients first are given antineoplastic drugs and then transfer to operative room to be treated by surgical resection and the radiotherapy is given during the operation after the removal of the tumour.

Radiation: Intraoperative radiotherapy by Intrabeam（Zeiss Meditech，Jena，Germany）

B group

NO INTERVENTION

Colorectal cancer patients first are given antineoplastic drugs and then transfer to operative room to be treated only by surgical resection and no radiotherapy afer the removal of the tumour.

Interventions

Intraoperative radiotherapy by Intrabeam（Zeiss Meditech，Jena，Germany）RADIATION

We confirmed that if the patients had the distant metastasis before IORT. The median radiation dose was 5.00 Gy (range: 5.00-10.00Gy), the average dose was 6.00 Gy. The median radiation time was 0:33:24 (range: 0:21:45-1:06:23), which was the same with the patients'. All patients' surface dose ranged from 15.00 to 28.50 Gy.

A group

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged 40 to 80 years old, gender not limited.
  • Be diagnosed as colorectal cancer by coloscopy.
  • Patients with middle and low rectal cancer,whose preoperative staging evaluation is T3 ,T4 or N+.
  • Accept surgery and intraoperative radiotherapy.
  • Signed informed consent

You may not qualify if:

  • the patients whose preoperative evaluation is below T3 stage with middle and rectal cancer.
  • Active internal bleeding (such as gastrointestinal bleeding), urogenital system, or have not cure of peptic ulcer in four weeks
  • Severe liver and kidney dysfunction
  • Intracranial tumor, suspicious aortic dissection, arteriovenous malformation, aneurysm
  • Thrombolysis treatment in one week
  • Allergies of thrombolysis drug or contrast
  • Participated in any clinical trials within three months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Second Hospital of Jilin University

Changchun, Jilin, 130041, China

RECRUITING

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

Wangsheng Xue

CONTACT

(+86)17625642616907588917@qq.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 30, 2017

First Posted

July 6, 2017

Study Start

January 1, 2015

Primary Completion

December 30, 2020

Study Completion

December 30, 2020

Last Updated

July 6, 2017

Record last verified: 2017-07

Data Sharing

IPD Sharing
Will share

When the investigators complete the study and publish our data.

Shared Documents
STUDY PROTOCOL, CSR
Time Frame
When the investigators complete the study and publish our data.

Locations

CN(1)