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

Study on the Value of Multi-points and Full-thickness Biopsy in the Diagnosis of Clinical Complete remiSsion After Neoadjuvant Therapy for Rectal Cancer

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.

Study Overview

• Status: Recruiting
• Conditions: Rectal Cancer; Metastasis; Neoadjuvant Therapy; Complete Remission
• Intervention / Treatment: Procedure: multi-points and full-thickness Biopsy; Diagnostic test: traditional cCR

• Study Type: Interventional
• Enrollment (Anticipated): 260
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100020
      • Recruiting
      • Beijing Chaoyang Hospital

Participation Criteria

Eligibility Criteria

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

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Biopsy cCR; 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.	Procedure: multi-points and full-thickness Biopsy; Four points around the tumor site and center of the tumor site full-thickness Biopsy
Active Comparator: Conventional cCR; Based on digital examination, serum CEA level, rectal MRI, endoscopy presentation, to study accuracy of cCR after neoadjuvant therapy for rectal cancer.	Diagnostic test: traditional cCR; diginal examination, endoscopy test, rectal MRI, and serum CEA level

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Complete Response rate	Clinical complete response rate between two groups after examinations following preoperative chemoradiotherapy for rectal cancer	8-12 weeks after preoperative chemoradiotherapy for locally advanced rectal cancer
pathological complete remission	No tumor cell found in surgical specimens	2 weeks after patients received radical operation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease Free Survival	no tumor regrowth or recurrence or metastasis found	5 years after operation or "watch and wait" approach
Overall Survival	survive during following	5 years after operation or "watch and wait" approach

Collaborators and Investigators

• Sponsor: Beijing Chao Yang Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2028

Study Registration Dates

• First Submitted: February 4, 2021
• First Submitted That Met QC Criteria: February 4, 2021
• First Posted (Actual): February 8, 2021

Study Record Updates

• Last Update Posted (Estimate): February 21, 2023
• Last Update Submitted That Met QC Criteria: February 19, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: rectal cancer; regrowth; neoadjuvant therapy; clinical complete remission; full-thickness biopsy; watch-and wait
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Rectal Neoplasms
• Other Study ID Numbers: BIOPSY-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No