Exploiting Circulating Tumour DNA to Intensify the Postoperative Treatment Resected Colon Cancer Patients

Summary

The aims of this study are to evaluate if an intensified adjuvant treatment with FOLFOXIRI could increase the rate of cases with undetectable ct-DNA after chemotherapy and to evaluate if a further adjuvant treatment with Trifluridine/Tipiracil could increase the rate of cases with undetectable ct-DNA and therefore improve DFS in a population at high-risk of relapse.

An additional target-driven cohort of HER2+ RAS wild-type colon cancer patients will be assessed for ct-DNA clearance after a tailored treatment with Trastuzumab and Tucatinib plus FOLFOX

Conditions

• Stage II Colon Cancer
• Stage III Colon Cancer
• HER2-positive Colon Cancer
• RAS Wild-type Colon Cancer

Interventions

DRUG

5-Fluorouracil continuous infusion FOLFOXIRI schedule

3200 mg/sqm 48 h-continuous infusion, starting on day 1. To be repeated every two weeks for a maximum of 12 cycles.

DRUG

5-Fluorouracil bolus FOLFOX schedule

400 mg/sqm iv bolus, day 1. To be repeated every two weeks for a maximum of 12 cycles.

DRUG

5-Fluorouracil continuous infusion FOLFOX schedule

2400 mg/sqm 48 h-continuous infusion, starting on day 1. To be repeated every two weeks for a maximum of 12 cycles.

DRUG

Oxaliplatin FOLFOX and FOLFOXIRI schedule

85 mg/sqm iv over 2 hours, day 1. To be repeated every two weeks for a maximum of 12 cycles.

DRUG

Oxaliplatin CAPOX schedule

130 mg/sqm iv over 2 hours, day 1. To be repeated every three weeks for a maximum of 8 cycles.

DRUG

L-Leucovorin

200 mg/sqm iv over 2 hours, day 1. To be repeated every two weeks for a maximum of 12 cycles.

DRUG

Capecitabine

Capecitabine 1000 mg/sqm/bid per os from day 1 to day 14. To be repeated every 3 weeks until 8 cycles. Available as 500 and 150 mg tablets.

DRUG

Irinotecan

165 mg/sqm iv over 60 minutes, day 1. To be repeated every two weeks for a maximum of 12 cycles.

DRUG

Trifluridine/Tipiracil

35 mg/m2/bid per os days 1-5 and 8-12. To be repeated every 4 weeks until 6 cycles. Available as 20 and 15 mg tablets.

DRUG

Trastuzumab

4 mg/kg iv over 30 minutes, day 1 (loading dose: 6 mg/kg iv over 90 minutes). To be repeated every two weeks for a maximum of 12 cycles.

DRUG

Tucatinib

300 mg (two 150 mg tablets)/bid orally twice daily (approximately 8 to 12 hours between doses with or without a meal) for a maximum of 12 biweekly cycles.

Sponsors & Collaborators

• Servier

  collaborator INDUSTRY

• Foundation Medicine

  collaborator INDUSTRY

• Seagen Inc.

  collaborator INDUSTRY

• Gruppo Oncologico del Nord-Ovest

  lead OTHER

Principal Investigators

• Roberto Moretto, MD · Azienda Ospedaliero, Universitaria Pisana

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-05-17

Primary Completion

2027-10-31

Completion

2029-12-31

Countries

• Italy

Study Locations