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

NCT04743102 | Recruiting DMC

• 1 other identifier: BIOPSY-01
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 1

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.

Conditions

Rectal Cancer; Neoadjuvant Therapy; Complete Remission; Metastasis

Keywords

rectal cancer; neoadjuvant therapy; clinical complete remission; full-thickness biopsy; watch-and wait; regrowth

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Disease Free Survival

  5 years after operation or "watch and wait" approach

• Overall Survival

  5 years after operation or "watch and wait" approach

Study Arms (2)

Biopsy cCR

EXPERIMENTAL

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

Conventional cCR

ACTIVE COMPARATOR

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

Interventions

multi-points and full-thickness Biopsy PROCEDURE

Four points around the tumor site and center of the tumor site full-thickness Biopsy

Biopsy cCR

traditional cCR DIAGNOSTIC_TEST

diginal examination, endoscopy test, rectal MRI, and serum CEA level

Conventional cCR

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Beijing Chao Yang Hospital: lead

Study Sites (1)

Beijing Chaoyang Hospital

Beijing, Beijing Municipality, 100020, China

RECRUITING

MeSH Terms

Conditions

Rectal Neoplasms; Pathologic Complete Response; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Disease Progression; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplastic Processes

Study Officials

• Zhenjun Wang

  Beijing Chao Yang Hospital

  STUDY CHAIR

Central Study Contacts

Jiagang Han

CONTACT

86-10-85231604; hanjiagang@ccmu.edu.cn

Zhiwei Zhai

CONTACT

86-10-85231604; 913916215@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 4, 2021
• First Posted: February 8, 2021
• Study Start: January 1, 2021
• Primary Completion: December 31, 2023
• Study Completion (Estimated): December 31, 2028
• Last Updated: February 21, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)