Post-surgical Liquid Biopsy-guided Treatment of Stage III and High-risk Stage II Colon Cancer Patients: the PEGASUS Trial
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04259944|
Recruitment Status : Active, not recruiting
First Posted : February 7, 2020
Last Update Posted : July 27, 2022
|Condition or disease||Intervention/treatment||Phase|
|Colon Cancer||Drug: CAPOX Drug: Capecitabine Drug: FOLFIRI||Phase 2|
The LUNAR1 Test (Guardant Health, Redwood City, CA, USA) will be used for ctDNA determination. For the efficacy analysis, the PEGASUS cohort will be compared with a cohort of 420 patients from the TOSCA trial (NCT00646607) population matched 3:1 for all known prognostic phenotypes.
A post-surgical LB executed 2-4 weeks after surgery will guide a "Molecular Adjuvant" treatment as follows: i) ctDNA+ patients will receive CAPOX for 3 months; ii) ctDNA- patients will receive capecitabine (CAPE) for 6 months but will be retested after 1 cycle, and if found ctDNA+ will be switched to CAPOX treatment.
Immediately after the end of the "Molecular Adjuvant" treatment a further LB will be performed and instruct subsequent treatment. Positive patients (ctDNA+/+ and ctDNA-/+) will receive an up-scaled "Molecular Metastatic" systemic treatment for 6 months or until radiological progression or toxicity as follows: i) ctDNA+/+ patients will be treated with FOLFIRI; ii) ctDNA-/+ patients with CAPOX. These patients will be subjected to a LB after 3 months at the end of treatment and in case of positivity will be switched to FOLFIRI.
Patients experiencing ctDNA conversion to negative (ctDNA+/-) will receive a de-escalated treatment with CAPE for 3 months. 3 LB will be performed within 3 months and in case of positivity the patient will be switched to FOLFIRI. Patients with ctDNA-/- will be subjected to an interventional follow-up comprising 2 further LB and in case of positivity they will be switched to CAPOX treatment. PEGASUS is piggybacked to AlfaOmega (NCT04120935), a Master Observational Protocol that will follow patients from diagnosis to 5 years or recurrence/death (whichever comes first), collecting clinical data, radio-images and biological samples. AlfaOmega provides a clinical and logistic ecosystem for the seamless integration of PEGASUS clinical results with the biological underpinning of colon cancer.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||140 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Post-surgical Liquid Biopsy-guided Treatment of Stage III and High-risk Stage II Colon Cancer Patients: the PEGASUS Trial|
|Actual Study Start Date :||June 16, 2020|
|Estimated Primary Completion Date :||July 15, 2024|
|Estimated Study Completion Date :||October 15, 2024|
Experimental: Liquid Biopsy-Guided Adjuvant Treatment
A post-surgical LB executed 2-4 weeks after surgery will guide a "Molecular Adjuvant" treatment:
A post-Molecular Adjuvant treatment LB will be performed and instruct subsequent treatment:
• CAPE 1000 mg/m2 os twice daily
Cycle length is 3 weeks comprising 2 hours of oxaliplatin infusion every 21 days, 14 days of oral capecitabine and 7 days of resting.
• CAPE 1250 mg/m2 os twice daily
Cycle length is 3 weeks comprising 14 days of oral capecitabine and 7 days of resting.
Cycle length is 2 weeks comprising approximately 48 hours of infusion and 12 days of rest.
- Number of post-surgery and post-adjuvant false negative cases after a double ctDNA-negative detection [ Time Frame: 2 years ]Cases that become positive at subsequent interventional LB or that experience radiological relapse
- Disease-Free Survival (DFS) [ Time Frame: 2 & 3 years ]
- Overall Survival (OS) [ Time Frame: 5 years ]
- Safety and tolerability according to CTCAE version 5.0 [ Time Frame: 2 years ]
- Assessment of QLQ-C30 and CR-29 EORTC questionnaires [ Time Frame: 2 years ]
- Number of patients experiencing ctDNA seroconversion (i.e. ctDNA+ that become ctDNA-) after any chemotherapy regimen remaining disease free [ Time Frame: 2 & 3 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04259944
|Ospedale Policlinico San Martino IRCCS|
|Fondazione IRCCS Istituto Nazionale dei Tumori|
|Istituto Europeo di Oncologia IRCCS|
|Niguarda Cancer Center, ASST Grande Ospedale Metropolitano Niguarda|
|Istituto Oncologico Veneto IRCCS|
|Ospedale Santa Maria della Misericordia|
|Perugia, Italy, 06132|
|AULS della Romagna|
|Ravenna, Italy, 48121|
|Hospital Moises Broggi|
|Sant Joan Despí, Barcelona, Spain, 08970|
|University Hospital del Mar|
|Vall d'Hebron Institute of Oncology|
|INCLIVA Biomedical Research Institute|
|Study Chair:||Sara Lonardi, MD||Istituto Oncologico Veneto IRCCS|