Trial Protocol of a Phase II Study of MFOLFOXIRI After Metastasectomy in Patients with Oligometastatic Colorectal Cancer (FANTASTIC Study)

Overview

Journal J Anus Rectum Colon

Specialty General Surgery

Date 2024 Aug 1

PMID 39086881

Authors

Kozo Kataoka

Takeshi Yamada

Kentaro Yamazaki

Keita Mori

Nobuhisa Matsuhashi

Manabu Shiozawa

Takuma Iwai

Masahiro Goto

Masayoshi Yasui

Yasumasa Takii

Takeshi Suto

Yasuyuki Takamizawa

Naoto Takase

Shruti Sharma

Joe Ensor

Adham Jurdi

Minetta C Liu

Masataka Ikeda

Yukihide Kanemitsu

Affiliations

Soon will be listed here.

Abstract

Background: The survival benefit of adjuvant chemotherapy after surgical resection of oligometastases from colorectal cancer (CRC) remains unclear. The prognostic role of circulating-tumor DNA (ctDNA) was reported recently and a risk stratification strategy based on monitoring minimal/molecular residual disease (MRD) has been proposed, however, which drug regimen is most effective for ctDNA-positive patients is unknown.

Methods/design: Oligometastatic CRC patients planning to undergo surgery were registered in this study. After metastasectomy, the registered patients were enrolled in the treatment arm, in which 8 courses of modified-FOLFOXIRI (mFOLFOXIRI; irinotecan 150 mg/m, oxaliplatin 85 mg/m, l-leucovorin (l-LV) 200 mg/m, and 46-h continuous infusion of 5-fluorouracil (5-FU) 2400 mg/m every 2 weeks) followed by 4 courses of 5-FU/l-LV are administered. The patients who did not meet the eligibility criteria for the treatment arm or did not consent to mFOLFOXIRI enrolled in the observation arm in which standard of care treatment is provided. Prospective blood collections for retrospective ctDNA analysis are scheduled pre-surgery, and at 28 days, 4 and 7 months after surgery. The primary endpoint is treatment compliance at 8 courses of mFOLFOXIRI and the key secondary endpoints are the ctDNA-positivity rate and survival outcomes in ctDNA-positive and -negative groups. A total of 85 patients will be enrolled from 11 institutions. First patient-in was on July 2020. Accrual completed in February 2024.

Discussion: This study will potentially identify a better treatment strategy for patients with resectable oligometastatic CRC having postsurgical ctDNA positivity, compared to the current standard of care approaches.

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