Study to Evaluate the Use of Capecitabine in Monotherapy and in Combination With Oxaliplatin in Elderly Patients as Adjuvant Chemotherapy for Locally Advanced Colorectal Cancer.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Capecitabine, Oxaliplatin.
- Who it may be relevant to
- Registry conditions: Colorectal Cancer. Basic parameters: 70 years — 90 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Russia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Single-center, Open-label, Randomized Phase II Study to Evaluate the Use of Capecitabine in Monotherapy and in Combination With Oxaliplatin in Elderly Patients as Adjuvant Chemotherapy for Locally Advanced Colorectal Cancer.
Overview
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
- Drug Capecitabine
Capecitabine 2000mg/m2 from day 1 to 14 - Drug Oxaliplatin
Oxaliplatin 130mg/m2 on day 1, cycle of 21 days
Primary outcome measures
- The disease free survival [Time frame: 3 years]
Secondary outcome measures (3)
- The overall survival [Time frame: 5 years]
- Аssessment of the quality of life [Time frame: 5 years]
- Toxicity assessment [Time frame: 6 months]
Eligibility criteria
Inclusion criteria
- Age 70 years and older;
- Obtaining informed consent to participate in the study;
- Morphologically confirmed diagnosis of colorectal cancer;
- Stage III colorectal cancer;
- Underwent radical surgical intervention for primary colorectal tumor;
- ECOG score of 0 - I;
- Life expectancy of more than 6 months;
- No history of systemic drug therapy for CRC;
- Adequate liver, kidney and bone marrow function;
- Absence of severe uncontrolled concomitant chronic diseases and acute illnesses.
Exclusion criteria
- Having previously received any systemic therapy for CRC;
- Time after surgical treatment of more than 12 weeks;
- Stage I-II and IV disease;
- Confirmed dihydropyrimidine dehydrogenase deficiency in blood by PCR (alteration of alleles c.\[190511G > A\], c.\[1679T >G\],\[2846A > T\], \[1129-5923C >G\], \[c.1236 G>A(HapB3)\]);
- Severe uncontrolled comorbid chronic diseases or acute illnesses;
- Presence of a second malignancy (except for previously cured malignancies);
- Any condition that, in the opinion of the physician, would interfere with the study procedures.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Russia · 1 center
- Research Institute of Clinical Oncology "Nizhny Novgorod Regional Clinical Oncological Dis — Nizhny Novgorod
Identifiers
NCT: NCT06888843 · CRR-2025