Status:
UNKNOWN
Neoadjuvant Chemotherapy in Patients With Intermediate Risk Upper and Mid Rectal Cancer
Lead Sponsor:
Blokhin's Russian Cancer Research Center
Conditions:
Rectal Neoplasms Malignant
Rectum Carcinoma
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief 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 c...
Detailed Description
This trial aims to investigate the efficacy of neoadjuvant chemotherapy compared to upfront surgery in intermediate risk rectal cancer patients. This is a prospective multicenter open-label randomized...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2024
Estimated Enrollment :
560 Patients enrolled
Trial Details
Trial ID
NCT04103697
Start Date
August 1 2019
End Date
August 1 2024
Last Update
February 9 2021
Active Locations (1)
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1
N.N.Blokhin Russian Cancer Research Center
Moscow, Russia, 115478