Actively Recruiting
Multi-points and Full-thickness Biopsy in the Diagnosis of cCR After Neoadjuvant Therapy for Rectal Cancer
Led by Beijing Chao Yang Hospital · Updated on 2023-02-21
260
Participants Needed
1
Research Sites
417 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Multi-points and Full-thickness Biopsy in the Diagnosis of cCR After Neoadjuvant Therapy for Rectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult male and female, between 18 and 80 years old
- Colonoscopy biopsy pathology confirmed colorectal adenocarcinoma
- Tumor located with lower margin within 12 cm of the anal margin or within 8 cm of the anorectal ring
- Hematopoietic functions of heart, lung, liver, kidney and bone marrow suitable for surgery and anesthesia
- Initial local MRI stage T2 or T3A or T3B, N0-2, negative for extramural vascular invasion, circumferential resection margin involvement, and no peripheral iliac, common iliac, obturator, or abdominal aortic lymph node metastasis
- Clinical complete response evaluated after neoadjuvant therapy with no mass or ulcer on digital rectal exam; endoscopy showing only flat scar, telangiectasia or pallor; no residual tumor on MRI or ultrasound; normal serum carcinoembryonic antigen (CEA)
- Signed informed consent for surgery
You will not qualify if you...
- Previous history of malignant colorectal tumor
- Complications requiring emergency surgery such as intestinal obstruction, perforation, or bleeding
- Unresectable lymph node metastasis
- Recent diagnosis of other malignant tumors
- Participation in other clinical trials within 4 weeks prior to enrollment
- ASA rating of IV or higher and/or ECOG physical status score of 2 or higher
- Severe liver, kidney, cardiopulmonary, or coagulation dysfunction or serious basic diseases preventing surgery
- History of serious mental illness
- Pregnant or lactating women
- Uncontrolled infection
- Other clinical or laboratory conditions deemed unsuitable for study participation by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Beijing Chaoyang Hospital
Beijing, Beijing Municipality, China, 100020
Actively Recruiting
Research Team
J
Jiagang Han
CONTACT
Z
Zhiwei Zhai
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here