Neoadjuvant Chemotherapy in Patients With Intermediate Risk Upper and Mid Rectal Cancer

• Status: Enrolling by invitation
• Trial end date: 2024-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether 4 cycles of neoadjuvant CapOx chemotherapy is more effective than the upfront surgery in patients with intermediate risk CRM"-" mid and upper 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

• cT3-4aN1-2M0 cancer of the upper rectum or сТ2-Т3bN1M0 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