NCT05947838

A Prospective Feasibility Study Using ctDNA to Tailor Neoadjuvant Chemotherapy for Patients With Colorectal or Appendiceal Adenocarcinoma

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To learn if circulating tumor DNA (ctDNA) testing before cytoreductive surgery (CRS) with or without heated intraperitoneal chemotherapy (HIPEC) can show if patients have a low or high risk of the disease returning and help doctors decide if less or more intense chemotherapy is needed as treatment before surgery. ctDNA testing measures the amount of tumor DNA (genetic information) in the blood.

Detailed description

Primary Objectives: • The primary aim of this prospective study is to assess and compare the recurrence-free survival following CRS and HIPEC of carcinomatosis of colorectal or appendiceal origin with curative intent among ctDNA-negative and ctDNA-positive patients based on their ctDNA status immediately prior to CRS and HIPEC Secondary Objectives: * To assess 1 and 2-year recurrence-free survival following CRS and HIPEC with curative intent among ctDNA-negative and ctDNA-positive patients * To assess and compare 2-year overall survival following CRS and HIPEC among ctDNA-negative and ctDNA-positive patients * To assess the duration of response, including duration of overall response, duration of overall CR and duration of stable disease * To evaluate the proportion of ctDNA-negative patients at 1-year post-resection * To compare survival rate of ctDNA-negative patients undergoing ctDNA-guided postoperative chemotherapy to historical controls * To evaluate proportion of patients in each arm who change chemotherapy in response to ctDNA measurement * To delineate the pattern of disease recurrence * To assess ctDNA sensitivity and specificity for predicting disease recurrence * To evaluate and correlate patient molecular subtypes and characterization of tumor biologic factors that are associated with ctDNA detection * To evaluate and correlate cross-sectional imaging characteristics of tumors with biologic factors such as pathologic response, ctDNA detection, and recurrence free survival

Conditions

• Appendiceal Adenocarcinoma
• Colorectal

Interventions

Type	Name	Description
PROCEDURE	Circulating tumoral DNA directed neoadjuvant therapy arm	Given by IV (vein)

Timeline

• Start date: 2023-12-04
• Primary completion: 2026-04-30
• Completion: 2026-04-30
• First posted: 2023-07-17
• Last updated: 2025-11-10

Locations

1 site across 1 country: United States