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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:
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).
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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fluoropyrimidines in mono-regimen | Experimental | Capecitabine 2000mg/m2 per day, orally from day 1 to 14, 1 week break. Cycle of 21 days (start the next course on day 22). |
|
| Combination chemotherapy based on platinum preparations | Experimental | XELOX: Oxaliplatin 100-130mg/m2 w/v #1 on day 1 + Capecitabine 2000mg/m2 per day, orally from day 1 to 14, 1 week break. Cycle of 21 days (start of the next course on day 22). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Capecitabine | Drug | Capecitabine 2000mg/m2 from day 1 to 14 |
|
| Measure | Description | Time Frame |
|---|---|---|
| The disease free survival | Time from randomization to disease recurrence | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| The overall survival | 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. | 5 years |
| Аssessment of the quality of life |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Arina Datsyuk | Contact | +79049209496 | doc70doc@yandex.ru | |
| MIKHAIL OSIPOV | Contact | +79052075653 | ocipovmixail@mail.ru |
| Name | Affiliation | Role |
|---|---|---|
| Sergey Gamayunov, DMS | Study Director | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Institute of Clinical Oncology "Nizhny Novgorod Regional Clinical Oncological Dispensary" | Recruiting | Nizhny Novgorod | 603126 | Russia |
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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.
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| Oxaliplatin | Drug | Oxaliplatin 130mg/m2 on day 1, cycle of 21 days |
|
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).
| 5 years |
| Toxicity assessment | Treatment toxicity according to common terminology criteria for adverse events version 5.0 | 6 months |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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| ID | Term |
|---|---|
| D000069287 | Capecitabine |
| D000077150 | Oxaliplatin |
| ID | Term |
|---|---|
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
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