Stage III and high-risk stage II colon cancer MedDRA version: 21.0 Level: PT Classification code 10061451 Term: Colorectal cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: capecitabine
Product Code: capecitabine
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: CAPECITIABINE
CAS Number: 154361-50-9
Current Sponsor code: CAPECITIABINE
Other descr
Sponsors
IFOM - Istituto FIRC di Oncologia Molecolare
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Pegasus trial written informed consent. 2. Age = 18 years. 3. Histologically confirmed diagnosis of operable stage III or T4N0 stage II colon cancer located 12 cm from the anal verge by endoscopy and above the peritoneal reflection at surgery. 4. Availability of plasma collected prior to surgery. 5. Availability of the original FFPE tumor tissue. 6. Acceptance to undergo at least all the interventional liquid biopsies. 7. ECOG performance status 0-1. 8. Normal organ functions. (as defined in section 9.3) 9. Women with childbearing potential should complete a pregnancy test and be willing to use highly effective contraceptive Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 70 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 70
Exclusion criteria
Exclusion criteria: 1. Patients having a MSI-H/MMRd tumor are excluded from the study (done according to standard clinical practice). 2. History of another neoplastic disease, unless in remission for = 5 years. Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g. breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded. 3. Had an incomplete diagnostic colonoscopy and/or polyps removal. 4. Macroscopic or microscopic evidence of residual tumor (R1 or R2 resections). Patients should never have had any evidence of metastatic disease (including presence of tumor cells in the peritoneal lavage). 5. Current or recent treatment with another investigational drug or participation in another investigational study 6. Patient unable to comply with the study protocol owing to psychological, social or geographical reasons. 7. Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study. 8. Inadequate contraception (male or female patients) if of childbearing or procreational potential. 9. Clinically relevant cardiovascular disease. 10. Acute or subacute intestinal occlusion or history of inflammatory bowel disease. 11. Pre-existing neuropathy > grade 1. Known grade 3 or 4 allergic reaction to any of the components of the treatment. 12. Has a known Gilbert Syndrome or UGT1A1 homozygous *28/*28 germline variant. 13. Has a known DPD (DihydroPyrimidine Dehydrogenase) deficiency. 14. Has a known history of Human Immunodeficiency Virus (HIV). Note: No HIV testing is required. 15. Has a known history of Hepatitis B (defined as Hepatitis B surface antigen [HBsAg] reactive)or known active Hepatitis C virus infection. Note: no testing for Hepatitis B and Hepatitis C isrequired unless mandated by local health authority. 16. Has a known history of active TB (Bacillus
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to study the feasibility of using liquid biopsy to guide the post-surgical and post-adjuvant clinical management of stage III and high-risk stage II (T4N0) MSS colon cancer patients. Feasibility is defined as the ability of at least two subsequent negative ctDNA determination to identify patients that will be NED (without radiologic evidence of metastasis) 2 years aftersurgery;Secondary Objective: - To compare the DFS and OS rates at 2,3 and 5 years in a cohort of 140 stage III and high-risk stage II (only T4N0) MSS colon cancer patients treated post-surgically with a LB guided strategy, with the DFS and OS rates of a 1:3 phenotypically matched cohort of the TOSCA trial treated with FOLFOX/CAPOX either at 3 or 6 months. • To compare the safety profile in a cohort of 140 stage III and high-risk stage II (only T4N0) MSS colon cancer patients treated with a liquid biopsy-guided strategy, with the safety profile of 1:3 phenotypically matched cohort of the TOSCA trial treated with FOLFOX/CAPOX at 3 or 6 months. • To validate LB seroconversion as a proxy of therapy efficacy and to compare its performance with CEA testing whenever CEA levels are above the normal values. • To study the QoL of patients in a cohort of 140 stage III and high-risk stage II (only T4N0) MSS colon cancer patients treated post-surgically with a liquid biopsyguided strategy;Primary end point(s): Number of post-surgery and post-adjuvant false negative cases after a double ctDNAnegative detection, defined as cases that become positive at subsequent interventional LB or that experience radiological relapse within 2 years.;Timepoint(s) of evaluation of this end point: within 2 years from surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1- Disease-Free Survival (DFS) at 2 and 3-years, Overall Survival (OS) at 5-years. 2- Safety and tolerability avvording to CTCAE version 4.03 3- Number of patients experiencing ctDNA seroconversion (i.e. ctDNA+ that become ctDNA-) after any chemotherapy regimen remaining disease free at 2 and 3 years. 4- Assessment of QLQ-C30 and CR-29 EORTC questionnaires;Timepoint(s) of evaluation of this end point: 1- 2, 3 and 5 years 2- the whole study 3- at 2 and 3 years 4- the whole study | — |
Countries
Italy, Spain
Contacts
Public ContactPrecision Oncology Unit
IFOM - Istituto FIRC di Oncologia Molecolare
Outcome results
None listed