Rectal Cancer Clinical Trial
— RuCorT-03Official title:
Induction and Consolidation Chemotherapy in Locally Advanced Rectal Cancer Patients With Circumferential Resection Margin Involvement: a Multicenter Prospective Randomized Phase III Clinical Trial
Verified date | February 2021 |
Source | Blokhin's Russian Cancer Research Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Enrolling by invitation |
Enrollment | 540 |
Est. completion date | October 2024 |
Est. primary completion date | October 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Russian Federation | N.N.Blokhin Russian Cancer Research Center | Moscow |
Lead Sponsor | Collaborator |
---|---|
Blokhin's Russian Cancer Research Center |
Russian Federation,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 3-year disease-free survival | 3 years | ||
Secondary | Adjuvant chemotherapy compliance | Proportion of patients who receive a complete course of adjuvant chemotherapy | 6 months | |
Secondary | Acute chemotherapy toxicity | Toxicity measured according to NCI-CTCAE v.5.0 | 6 months | |
Secondary | pathologic complete response rate (pCR) | 1 month | ||
Secondary | local recurrence rate | 3 years | ||
Secondary | 3-year overall survival | 3 years | ||
Secondary | Operative morbidity | Morbidity measured according to Clavien-Dindo classification | 30 days | |
Secondary | Preoperative tumor-associated complications rate | The rate of tumor-associated complications (bowel obstruction, bleeding etc) during neoadjuvant chemotherapy | 6 months | |
Secondary | Sphincter preservation rate | 1 month |
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