NCT05062889 - Exploiting Circulating Tumour DNA to Intensify the Postoperative Treatment Resected Colon Cancer Patients | Biotech Hunter

Enrollment

477

Participants

Timeline

Start Date

May 17, 2023

Primary Completion Date

October 31, 2025

Study Completion Date

December 31, 2027

Conditions

Stage II Colon CancerStage III Colon CancerHER2-positive Colon CancerRAS 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.

Trial Locations (28)

10060

RECRUITING

IRCCS di Candiolo, Torino

16128

RECRUITING

E.O. Ospedali Galliera di Genova, Genova

20132

RECRUITING

Ospedale San Raffaele, Milan

20133

RECRUITING

Fondazione IRCCS INT - Milano, Milan

25123

RECRUITING

Spedali Civili di Brescia, Brescia

25124

RECRUITING

Fondazione POLIAMBULANZA ISTITUTO OSPEDALIERO, Brescia

28100

RECRUITING

Azienda Ospedaliero Universitaria Maggiore della Carita, Novara

29121

RECRUITING

Azienda USL di Piacenza, Piacenza

33100

RECRUITING

Azienda Sanitaria Universitaria Friuli Centrale, Udine

35128

RECRUITING

Istituto Oncologico Veneto IOV - IRCCS, Padua

42123

RECRUITING

Azienda USL IRCCS di Reggio Emilia (centro principale Reggio Emilia e centro satellite Guastalla)., Reggio Emilia

44100

RECRUITING

A.O.U. di Ferrara Arcispedale Sant'Anna, Ferrara

47014

RECRUITING

"Istituto Romagnolo per lo Studio dei Tumori Dino Amadori", Meldola

48121

RECRUITING

AUSL Romagna, Ravenna

50134

RECRUITING

A.O.U Careggi, Florence

52100

RECRUITING

Ospedale San Donato di Arezzo, Arezzo

53100

RECRUITING

Ospedale Campostaggia Poggiponsi, Siena

55100

RECRUITING

Ospedale San Luca di Lucca, Lucca

57124

RECRUITING

Azienda USL Toscana Nord Ovest di Livorno, Livorno

58100

RECRUITING

Ospedale Misericordia di Grosseto, Grosseto

59100

RECRUITING

Nuovo Ospedale di Prato, Prato

71013

RECRUITING

Fondazione Casa Sollievo della Sofferenza, San Giovanni Rotondo

73039

RECRUITING

Azienda Ospedaliera Cardinale Giovanni Panico, Tricase

09042

RECRUITING

"AOU Cagliari PO Policlinico Universitario Duilio Casula Presidio Policlinico Universitario Duilio Casula", Cagliari

00133

RECRUITING

Policlinico Tor Vergata Roma, Roma

00144

RECRUITING

Istituto per la ricerca sui tumori Regina Elena, Roma

00168

RECRUITING

Policlinico Fondazione Agostino Gemelli, Roma

00186

RECRUITING

Ospedale Fatebenefratelli Isola Tiberina, Roma