Overview
Neoadjuvant Chemotherapy in Patients With Moderate Risk Mid Rectal Cancer
Status:
Enrolling by invitation
Enrolling by invitation
Trial end date:
2024-10-01
2024-10-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
The purpose of this study is to determine whether 3 months of neoadjuvant CapOx is non-inferior to neoadjuvant radiotherapy in patients with moderate risk CRM"-" mid rectal cancer.Phase:
Phase 3Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Blokhin's Russian Cancer Research CenterTreatments:
Capecitabine
Oxaliplatin
Criteria
Inclusion Criteria:- Informed consent
- Histologically verified colon rectal adenocarcinoma
- сT3c-T3dN0-1M0, cT1-T3dN2M0. cancer of the middle rectum (based on pelvic MRI)
- Tumor more than 2 mm from mesorectal fascia (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
- 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