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Multi-points and Full-thickness Biopsy in the Diagnosis of cCR After Neoadjuvant Therapy for Rectal Cancer (BIOPSY)

Primary Purpose

Rectal Cancer, Neoadjuvant Therapy, Complete Remission

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
multi-points and full-thickness Biopsy
traditional cCR
Sponsored by
Beijing Chao Yang Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rectal Cancer focused on measuring rectal cancer, neoadjuvant therapy, clinical complete remission, full-thickness biopsy, watch-and wait, regrowth

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adult male and female, between 18 and 80 years old;
  • Colonoscopy biopsy pathology confirmed colorectal adenocarcinoma;
  • The distance from the lower margin of the tumor to the anal margin ≤12 cm (endoscope) or to the anorectal ring ≤8 cm;
  • The hematopoietic functions of heart, lung, liver, kidney and bone marrow meet the requirements of surgery and anesthesia;
  • Initial local MRI stage was T2 or T3A or T3B, N0-2, negative for extramural vascular invasion (EMVI), circumferential ential resection margin (CRM), and no peripheral iliac, common iliac, obturator, or abdominal aortic lymph node metastasis;
  • CCR patients evaluated after neoadjuvant therapy (no mass or ulcer found on digital rectal examination;Endoscopic examination showed no other changes except flat scar, telangiectasia or pallor of mucosa.MRI or rectal ultrasound showed no residual tumor in the primary site and lymphatic drainage area.Serum carcinoembryonic antigen (CEA) was normal.
  • Signing informed consent for surgery.

Exclusion Criteria:

  • Previous history of malignant colorectal tumor;
  • Patients complicated with intestinal obstruction, intestinal perforation, intestinal bleeding and other patients requiring emergency surgery;
  • Unresectable lymph node metastasis;
  • Recently diagnosed with other malignant tumors;
  • Patients who had participated in or were participating in other clinical trials within 4 weeks prior to enrollment;
  • ASA rating ≥IV and/or ECOG physical status score ≥2 points;
  • Patients with severe liver and kidney function, cardiopulmonary function, coagulation dysfunction or combined with serious basic diseases cannot tolerate surgery;

  • a history of serious mental illness;

    - pregnant or lactating women;

  • Those with uncontrolled infection;
  • Patients with other clinical or laboratory conditions considered by the investigator should not participate in the study

Sites / Locations

  • Beijing Chaoyang HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Biopsy cCR

Conventional cCR

Arm Description

Based on digital examination, serum CEA level, rectal MRI, endoscopy presentation, we add multi-points and full-thickness Biopsy to further improve the accuracy of cCR after neoadjuvant therapy for rectal cancer.

Based on digital examination, serum CEA level, rectal MRI, endoscopy presentation, to study accuracy of cCR after neoadjuvant therapy for rectal cancer.

Outcomes

Primary Outcome Measures

Clinical Complete Response rate
Clinical complete response rate between two groups after examinations following preoperative chemoradiotherapy for rectal cancer
pathological complete remission
No tumor cell found in surgical specimens

Secondary Outcome Measures

Disease Free Survival
no tumor regrowth or recurrence or metastasis found
Overall Survival
survive during following

Full Information

First Posted
February 4, 2021
Last Updated
February 19, 2023
Sponsor
Beijing Chao Yang Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04743102
Brief Title
Multi-points and Full-thickness Biopsy in the Diagnosis of cCR After Neoadjuvant Therapy for Rectal Cancer
Acronym
BIOPSY
Official Title
Study on the Value of Multi-points and Full-thickness Biopsy in the Diagnosis of Clinical Complete remiSsion After Neoadjuvant Therapy for Rectal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Chao Yang Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Background There is currently no reliable means to restage rectal cancers after neoadjuvant chemoradiation. There are still no reliable methods to identify patients with pCR before radical surgery. As a result, clinical complete response (cCR), defined as no clinical detectable tumor by physical examination, endoscopic evaluation, and imaging, is designed as a surrogate endpoint for pCR. However, the concordance between cCR and pCR varies from 22% to 96% in different reports, which questions the clinical value of such strategies. Therefore, based on rectal diginal examination, serum CEA, MRI, endoscopy examination, we suggested to add multi-points and full-thickness biopsy technique to further improve the accuracy of cCR.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Cancer, Neoadjuvant Therapy, Complete Remission, Metastasis
Keywords
rectal cancer, neoadjuvant therapy, clinical complete remission, full-thickness biopsy, watch-and wait, regrowth

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
260 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Biopsy cCR
Arm Type
Experimental
Arm Description
Based on digital examination, serum CEA level, rectal MRI, endoscopy presentation, we add multi-points and full-thickness Biopsy to further improve the accuracy of cCR after neoadjuvant therapy for rectal cancer.
Arm Title
Conventional cCR
Arm Type
Active Comparator
Arm Description
Based on digital examination, serum CEA level, rectal MRI, endoscopy presentation, to study accuracy of cCR after neoadjuvant therapy for rectal cancer.
Intervention Type
Procedure
Intervention Name(s)
multi-points and full-thickness Biopsy
Intervention Description
Four points around the tumor site and center of the tumor site full-thickness Biopsy
Intervention Type
Diagnostic Test
Intervention Name(s)
traditional cCR
Intervention Description
diginal examination, endoscopy test, rectal MRI, and serum CEA level
Primary Outcome Measure Information:
Title
Clinical Complete Response rate
Description
Clinical complete response rate between two groups after examinations following preoperative chemoradiotherapy for rectal cancer
Time Frame
8-12 weeks after preoperative chemoradiotherapy for locally advanced rectal cancer
Title
pathological complete remission
Description
No tumor cell found in surgical specimens
Time Frame
2 weeks after patients received radical operation
Secondary Outcome Measure Information:
Title
Disease Free Survival
Description
no tumor regrowth or recurrence or metastasis found
Time Frame
5 years after operation or "watch and wait" approach
Title
Overall Survival
Description
survive during following
Time Frame
5 years after operation or "watch and wait" approach

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult male and female, between 18 and 80 years old; Colonoscopy biopsy pathology confirmed colorectal adenocarcinoma; The distance from the lower margin of the tumor to the anal margin ≤12 cm (endoscope) or to the anorectal ring ≤8 cm; The hematopoietic functions of heart, lung, liver, kidney and bone marrow meet the requirements of surgery and anesthesia; Initial local MRI stage was T2 or T3A or T3B, N0-2, negative for extramural vascular invasion (EMVI), circumferential ential resection margin (CRM), and no peripheral iliac, common iliac, obturator, or abdominal aortic lymph node metastasis; CCR patients evaluated after neoadjuvant therapy (no mass or ulcer found on digital rectal examination;Endoscopic examination showed no other changes except flat scar, telangiectasia or pallor of mucosa.MRI or rectal ultrasound showed no residual tumor in the primary site and lymphatic drainage area.Serum carcinoembryonic antigen (CEA) was normal. Signing informed consent for surgery. Exclusion Criteria: Previous history of malignant colorectal tumor; Patients complicated with intestinal obstruction, intestinal perforation, intestinal bleeding and other patients requiring emergency surgery; Unresectable lymph node metastasis; Recently diagnosed with other malignant tumors; Patients who had participated in or were participating in other clinical trials within 4 weeks prior to enrollment; ASA rating ≥IV and/or ECOG physical status score ≥2 points; Patients with severe liver and kidney function, cardiopulmonary function, coagulation dysfunction or combined with serious basic diseases cannot tolerate surgery; a history of serious mental illness; - pregnant or lactating women; Those with uncontrolled infection; Patients with other clinical or laboratory conditions considered by the investigator should not participate in the study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jiagang Han
Phone
86-10-85231604
Email
hanjiagang@ccmu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Zhiwei Zhai
Phone
86-10-85231604
Email
913916215@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhenjun Wang
Organizational Affiliation
Beijing Chao Yang Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Beijing Chaoyang Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100020
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jiagang Han
Phone
86-0-13522867841
Email
hjg211@163.com
First Name & Middle Initial & Last Name & Degree
Zhenjun Wang

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Multi-points and Full-thickness Biopsy in the Diagnosis of cCR After Neoadjuvant Therapy for Rectal Cancer

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