Status:
UNKNOWN
Induction and Consolidation Chemotherapy in Patients With Locally Advanced CRM-positive Rectal Cancer
Lead Sponsor:
Blokhin's Russian Cancer Research Center
Conditions:
Rectal Neoplasms Malignant
Rectum Carcinoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief 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 d...
Detailed Description
This trial aims to investigate the efficacy of adding neoadjuvant induction and consolidation chemotherapy compared to standard chemoradiotherapy in locally advanced rectal cancer patients with circum...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 20 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2024
Estimated Enrollment :
540 Patients enrolled
Trial Details
Trial ID
NCT04135313
Start Date
October 20 2019
End Date
October 1 2024
Last Update
February 9 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
N.N.Blokhin Russian Cancer Research Center
Moscow, Russia, 115478