Circulating Tumor DNA to Monitor the Efficacy of Total Neoadjuvant Therapy for Rectal Cancer

Withdrawn

• Conditions: Colorectal Cancer; Rectal Cancer

• Registration Number: NCT05356585
• Lead Sponsor: Case Comprehensive Cancer Center

Brief Summary

The purpose of this study is to use the SignateraTm assay created from rectal tumor biopsies to monitor participants' blood for fragments of DNA shed by tumor cells. The tumor DNA fragments are referred to as circulating tumor DNA, or ctDNA for short.

Detailed Description

Rectal cancer tissue samples that were collected from participants' previous biopsies will be sent to Natera for Signatera assay creation after enrollment onto the study.

One 6 mL tube of blood will be obtained at baseline prior to initiation of treatment. Blood will also be obtained in two 6 tubes at the following points: 3-4 weeks into chemoradiation therapy (CRT), after CRT, after chemotherapy, after surgery for those who undergo resection, and during surveillance 3 months after surgery or at the end of treatment for one year after completion of TNT (total neoadjuvant therapy).

The primary objective of the study is to estimate the percentage of patients with positive ctDNA at the end of TNT .

The secondary objectives of the study include:

1. Estimating the change in ctDNA after chemoradiation and chemotherapy

2. Characterize the correlation of complete response to TNT with presence or absence of ctDNA

3. Describe the recurrence rate in participants with and without ctDNA after TNT

4. Characterize the correlation of ctDNA at end of TNT with recurrence free survival at 2 years.

Study Timeline

• Study First Submitted: 2022-04-27
• Study First Submitted QC: 2022-04-27
• Study First Posted: 2022-05-02
• Study Start: 2023-12-30
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-11
• Last Update Posted: 2024-04-12
• Primary Completion: 2024-06-30
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Newly histologically documented rectal adenocarcinoma or biopsy-proven adenoma with MRI rectum and CT chest/abdomen or PET/CT imaging consistent with stage II or III disease
• Plan is for participant to undergo standard TNT with induction chemoradiation
• Age ≥ 18 years of age

Exclusion Criteria

• Stage I, recurrent, or metastatic rectal cancer
• Received prior therapy for this rectal cancer
• No baseline tumor biopsies with adenocarcinoma or adequate amount of tissue from biopsies available to send for SignateraTM assay development

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Detectable ctDNA at the Completion of TNT	up to 24 months after TNT	The percentage of participants with detectable ctDNA at the completion of TNT

Secondary Outcome Measures

Name	Time	Method
Correlation of Complete Response TNT	Up to 24 months after TNT	Correlation of complete response to TNT defined by presence or absence of ctDNA.
Change in ctDNA	up to 24 months after TNT	The change in ctDNA (continuous and categorical positive/negative) during and at the end of neoadjuvant chemoradiation and with chemotherapy will be measured. Continuous measurements will be summarized using medians and ranges. Categorical factors will be summarized using frequencies and percentages. Changes in ctDNA will be analyzed by using the Mann-Whitney U test or the Fisher's exact test for continuous or categorical variables, respectively.

Trial Locations

Locations (1)

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center; 🇺🇸 Cleveland, Ohio, United States