Colorectal Cancer
Conditions
Keywords
XELOX, Capecitabine, Overall survival, Disease free survival, Toxicity profile, Comprehensive geriatric evaluation
Brief summary
All patients with locally advanced colorectal cancer after radical surgical intervention who have not previously received systemic antitumor treatment will be randomized into two groups receiving fluoropyrimidines in mono-regimen and in combination with oxaliplatin. Main objectives: * to compare the 3-year disease-free survival and 5-year overall survival rates in the two groups. * to identify, through a comprehensive geriatric assessment among elderly patients, the groups that benefit most from adjuvant chemotherapy. Patients will be treated until progression of the process is detected or the maximum effect of therapy is reached (the longest duration of treatment is 6 months).
Detailed description
The study is a single-center, open-label, randomized Phase II study. The study will be divided into a screening phase (4 weeks prior to inclusion in the study), a treatment phase (up to 6 months) and a long-term follow-up phase (up to 28 days from the end of treatment - follow-up to assess the safety of therapy, up to 3 years from the end of treatment to assess survival and follow-up). During the screening phase, patients with MR CRC will undergo examinations to fulfill the inclusion and exclusion criteria for the study. Next, elderly patients meeting these criteria-who have locally advanced colorectal cancer-will be randomized in a ratio of approximately 1:1 into 2 groups. The study is planned to include 160 patients, 80 in each group, for a total of 160 patients. Patient groups 1. Capecitabine in mono-regimen 2. PCT according to XELOX regimen Stratification factors - gender m/f, age \<75 /\>75, presence of postoperative complications yes/no. The patients will be treated until the progression is detected or the maximum effect of therapy is achieved (the longest duration of treatment is 8 cycles). At the end of the treatment period, all patients will enter the observation phase.
Interventions
DRUGCapecitabine
Capecitabine 2000mg/m2 from day 1 to 14
DRUGOxaliplatin
Oxaliplatin 130mg/m2 on day 1, cycle of 21 days
Sponsors
Nizhny Novgorod Regional Clinical Oncology Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Parallel Assignment All patients with locally advanced colorectal cancer after radical surgical intervention who have not previously received systemic antitumor treatment will be randomized into two groups receiving fluoropyrimidines in mono-regimen and in combination with oxaliplatin.
Eligibility
Sex/Gender
ALL
Age
70 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
1. Age 70 years and older; 2. Obtaining informed consent to participate in the study; 3. Morphologically confirmed diagnosis of colorectal cancer; 4. Stage III colorectal cancer; 5. Underwent radical surgical intervention for primary colorectal tumor; 6. ECOG score of 0 - I; 7. Life expectancy of more than 6 months; 8. No history of systemic drug therapy for CRC; 9. Adequate liver, kidney and bone marrow function; 10. Absence of severe uncontrolled concomitant chronic diseases and acute illnesses.
Exclusion criteria
1. Having previously received any systemic therapy for CRC; 2. Time after surgical treatment of more than 12 weeks; 3. Stage I-II and IV disease; 4. Confirmed dihydropyrimidine dehydrogenase deficiency in blood by PCR (alteration of alleles c.\[190511G \> A\], c.\[1679T \>G\],\[2846A \> T\], \[1129-5923C \>G\], \[c.1236 G\>A(HapB3)\]); 5. Severe uncontrolled comorbid chronic diseases or acute illnesses; 6. Presence of a second malignancy (except for previously cured malignancies); 7. Any condition that, in the opinion of the physician, would interfere with the study procedures.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The disease free survival | 3 years | Time from randomization to disease recurrence |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The overall survival | 5 years | Time from randomization to death from any cause or date of last observation in the absence of these events. In months with an accuracy of 0.1. |
| Аssessment of the quality of life | 5 years | Quality of life assessment by European Organisation for Research and Treatment of Cancer scale Quality of Life Questionnaire - Core 30 (QLQ-C30) by Scoring of the QLQ-C30 Summary Score using the descriptive analysis with the qlqc30 command (detailed description in manual ISBN 2-9300 64-22-6). |
| Toxicity assessment | 6 months | Treatment toxicity according to common terminology criteria for adverse events version 5.0 |
Countries
Russia
Contacts
Primary ContactArina Datsyuk
Backup ContactMIKHAIL OSIPOV
Outcome results
None listed