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

Sponsor

Beijing Chao Yang Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT04743102

Collaborator

(none)

260

Enrollment

Location

Arms

Anticipated Duration (Months)

2.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Rectal Cancer Neoadjuvant Therapy Complete Remission Metastasis	Procedure: multi-points and full-thickness Biopsy Diagnostic Test: traditional cCR	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

260 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jan 1, 2021

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Dec 31, 2028

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Disease Free Survival [5 years after operation or "watch and wait" approach]
no tumor regrowth or recurrence or metastasis found
Overall Survival [5 years after operation or "watch and wait" approach]
survive during following

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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