Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT05427669

Adjuvant mFOLFOXIRI vs. mFOLFOX6 in MRD Positive Stage II-III Colorectal Cancer (AFFORD)

Surgery is the main treatment method for colon cancer. About 50% of patients can be cured with surgery alone. For colon cancer with high-risk stage II or III after surgery, the current guidelines recommend 3-6 months after surgery. adjuvant chemotherapy to reduce the risk of recurrence and metastasis. However, for this part of the population, the overall benefit of adjuvant chemotherapy is limited, and different high-risk factors have different weights; some patients will still experience recurrence and metastasis even after receiving adjuvant chemotherapy. A number of previous studies have shown that patients with a positive ctDNA test on postoperative liquid biopsy without postoperative adjuvant therapy have a recurrence risk of 70-80%. Even if they receive adjuvant chemotherapy, the recurrence risk is significantly higher than that of ctDNA-negative patients. ctDNA has received increasing attention as a predictor of postoperative recurrence risk.

This study intends to randomly assign 1:1 to mFOLFOXIRI regimen adjuvant chemotherapy for 6 months and mFOLFOX6 regimen for colon cancer patients with postoperative high-risk stage II-III and liquid biopsy results within 1 month after surgery. Adjuvant chemotherapy was performed for 6 months, ctDNA was dynamically monitored after 3 months of treatment and at the end of adjuvant therapy. During the follow-up period, CEA was reviewed every 3 months, and chest, abdomen, and pelvis CT and ctDNA were reviewed every 6 months; the primary endpoint of the study was 2 years RFS, secondary endpoints included 3-year DFS, OS, safety and tolerability. Through intensive postoperative adjuvant therapy, we hope to screen colon cancer patients with high recurrence risk to receive adjuvant chemotherapy and improve the survival prognosis of ctDNA-positive colon cancer patients.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasm, Residual Neoplasms Neoplasms by Site Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Rectal Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18-70 years old
  • Histological or cytological documentation of adenocarcinoma of the colon or rectum. All other histological types are excluded.
  • ECOG performance status 0-1
  • Upfront surgery (R0 resection) and postoperative pathological stage II -III and the circulating tumor DNA (ctDNA) test results show that MRD was positive
  • Randomization must be within 8 weeks after surgery.
  • No distant metastasis after surgery
  • Appropriate organ function

Exclusion criteria

  • Postoperative CT scan showed distant meatstasis
  • Patients with postoperative obstruction or active bleeding
  • Other active malignant tumors in the past or at the same time (except for malignant tumors that have received curative treatment and have no disease for more than 5 years or carcinoma in situ that can be cured by adequate treatment)
  • The time from postoperative to start of adjuvant therapy has exceeded 8 weeks
  • Patients who have received neoadjuvant therapy
  • Active coronary artery disease, severe/unstable angina or newly diagnosed angina or myocardial infarction within 12 months prior to study participation
  • Thrombotic or embolic events within the past 6 months, such as cerebrovascular accident (including transient ischemic attack), pulmonary embolism, deep vein thrombosis
  • Unstable or any medical condition that affects patient safety and study compliance
  • Subjects with known allergy to the study drugs or to any of its excipients.

Treatment and study plan

mFOLFOXIRI

Drug

mFOLFOXIRI (oxaliplatin 85 mg/m2, irinotecan 150 mg/m2, and folinic acid 400 mg/m2 followed by 5-fluorouracil 2400mg/m2 as a 46-hour continuous infusion on day 1) for 12 cycles at the most

Other names: Oxaliplatin, Irinotecan, 5-Fluorouracil, Leucovorin

mFOLFOX6

Drug

mFOLFOX6 (oxaliplatin 85 mg/m2, and folinic acid 400 mg/m2 followed by bolus 5-fluorouracil 400 mg/m2 and 5-fluorouracil 2400mg/m2 as a 46-hour continuous infusion on day 1) for 12 cycles at the most

Other names: Oxaliplatin, 5-Fluorouracil, Leucovorin

Primary outcomes

  1. 3-year Disease-free Survival (DFS)

    Time frame: 3 years

    The DFS is defined as the time from the start of treatment to the date of first documented recurrence or metastais or death as a result of any cause, whichever occurred first.

Secondary outcomes

  1. Overall survival

    Time frame: 3 years

    OS is defined as the time from date of randomization to death due to any cause. Subjects still alive at the time of analysis were censored at their last date of last contact.

  2. 3-year distant metastatic-free survival （DMFS）

    Time frame: 3 year

    The DMFS is defined as the time from the start of treatment to the date of first documented distant metastais or death as a result of any cause, whichever occurred first.

Study contacts

Contact information is provided by the study sponsor or research team.

Jianwei Zhang, Ph.D.

CONTACT

[email protected]

00862013480216906

Yanhong Deng, Ph.D.

CONTACT

[email protected]

008613925106525

Sponsors and collaborators

Lead sponsor

Yanhong Deng

Other

Registry information

Official study title

Adjuvant Modified FOLFOXIRI Versus mFOLFOX6 in Patients With Postoperative MRD Positive Stage II-III Colorectal Cancer: A Multicenter, Open Lable Randomized Phase 3 Study (AFFORD)

Acronym: AFFORD

Important dates

Study start
2022
Primary completion
2025
Study completion
2027
First posted
Jun 22, 2022
Registry last updated
Oct 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.