Overview

Induction and Consolidation Chemotherapy in Patients With Locally Advanced CRM-positive Rectal Cancer

Status:
Enrolling by invitation
Trial end date:
2024-10-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to determine whether the addition of 2 cycles of induction CapOx chemotherapy and 2 cycles of consolidation CapOx chemotherapy to standard chemoradiation improves 3-year disease-free survival in patients with locally advanced CRM"+" mid and low rectal cancer.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Blokhin's Russian Cancer Research Center
Treatments:
Capecitabine
Oxaliplatin
Criteria
Inclusion Criteria:

- Informed consent

- Histologically verified colon rectal adenocarcinoma 0-10 cm above the anal verge

- No distant metastases

- Circumferential resection margin (CRM) involvement (based on pelvic MRI)

- Eastern Cooperative Oncology Group (ECOG) status 0-2

- Haemoglobin (HGB) > 90 g/L

- Platelet Count (PLT) > 120x10*9/L

- Serum creatinine < 150 µmol/L

- Total bilirubin < 25 µmol/L

Exclusion Criteria:

- inability to obtain informed consent

- distant metastases

- cT2N0M0 rectal cancer

- synchronous or metachronous tumors

- previous chemotherapy or radiotherapy

- clinically significant cardiovascular disorders (myocardial infarction < 6 months
before visit, stroke < < 6 months before visit, instable angina < 3 months before
visit, arrhythmia, uncontrolled hypertension > 160/100 mm hg

- clinically significant neurological disorders

- previous neuropathy 2 or higher

- current infection or heavy systemic disease

- pregnancy, breastfeeding

- ulcerative colitis

- individual intolerance to treatment components

- proven dihydropyrimidine dehydrogenase (DPD) deficiency

- participation in other clinical trials

- psychiatric disorders, which render patient unable to follow instructions or
understand his/her condition

- technical inability to perform pelvic MRI

- inability of long-term followup of the patient

- HIV