A PRECISION MEDICINE TRIAL LEVERAGING BLOOD-BASED TUMOR GENOMICS TO OPTIMIZE TREATMENT IN OPERABLE STAGE III AND HIGH-RISK STAGE II COLON CANCER PATIENTS

Conditions

Colon cancer

Brief summary

2-year RFS in patients with a post-surgery ctDNA positivity randomized 1:1 to receive either a conventional adjuvant chemotherapy or a personalized targeted treatment strategy.

Detailed description

2-year RFS in patients with a post-surgery ctDNA negativity randomized 1:1 to receive either a physician-choice strategy or an intensive follow-up strategy., 3 and 5-year RFS and OS in patients with a post-surgery ctDNA positivity (Trial-1) and ctDNA negativity (Trial-2) randomized either in the conventional or experimental Trials., Safety and tolerability according to Clinical Trials Criteria for Adverse Events (CTCAE) version 5.0 (Trial-1, Trial-2 and whole study population)., Number of false negative cases after three consecutive negative LBs, defined as cases that experience radiological relapse within 2 years., Number of patients experiencing ctDNA seroconversion (i.e., ctDNA+ that become ctDNA-) after any therapy regimen remaining disease free at 2 and 3 years, Assessment of FACT-C and EQ-5D-5L questionnaires in the whole study population.

Related papers

No related papers found yet.

Interventions

DRUGPANITUMUMAB

DRUGCAPECITABINE

DRUGDISODIUM LEVOFOLINATE

DRUGCALCIUM LEVOFOLINATE

DRUGFLUOROURACIL

DRUGNIVOLUMAB

DRUGTEMOZOLOMIDE

DRUGFOLINIC ACID

DRUGTRASTUZUMAB

DRUGPERTUZUMAB

DRUGOXALIPLATIN

DRUGIPILIMUMAB

DRUGIRINOTECAN

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
2-year RFS in patients with a post-surgery ctDNA positivity randomized 1:1 to receive either a conventional adjuvant chemotherapy or a personalized targeted treatment strategy.	—

Secondary

Measure	Time frame
2-year RFS in patients with a post-surgery ctDNA negativity randomized 1:1 to receive either a physician-choice strategy or an intensive follow-up strategy., 3 and 5-year RFS and OS in patients with a post-surgery ctDNA positivity (Trial-1) and ctDNA negativity (Trial-2) randomized either in the conventional or experimental Trials., Safety and tolerability according to Clinical Trials Criteria for Adverse Events (CTCAE) version 5.0 (Trial-1, Trial-2 and whole study population)., Number of false negative cases after three consecutive negative LBs, defined as cases that experience radiological relapse within 2 years., Number of patients experiencing ctDNA seroconversion (i.e., ctDNA+ that become ctDNA-) after any therapy regimen remaining disease free at 2 and 3 years, Assessment of FACT-C and EQ-5D-5L questionnaires in the whole study population.	—

Measure

Time frame

2-year RFS in patients with a post-surgery ctDNA negativity randomized 1:1 to receive either a physician-choice strategy or an intensive follow-up strategy., 3 and 5-year RFS and OS in patients with a post-surgery ctDNA positivity (Trial-1) and ctDNA negativity (Trial-2) randomized either in the conventional or experimental Trials., Safety and tolerability according to Clinical Trials Criteria for Adverse Events (CTCAE) version 5.0 (Trial-1, Trial-2 and whole study population)., Number of false negative cases after three consecutive negative LBs, defined as cases that experience radiological relapse within 2 years., Number of patients experiencing ctDNA seroconversion (i.e., ctDNA+ that become ctDNA-) after any therapy regimen remaining disease free at 2 and 3 years, Assessment of FACT-C and EQ-5D-5L questionnaires in the whole study population.

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Countries

Germany, Italy, Spain

Outcome results

None listed