A Phase 2 interventional study of Capecitabine and Oxaliplatin in Colorectal Cancer, sponsored by Nizhny Novgorod Regional Clinical Oncology Center. Recruiting at 1 site in Russian Federation. Open to participants aged 70 Years to 90 Years. Per ClinicalTrials.gov, last updated 2025-03-27.
Sponsored by Nizhny Novgorod Regional Clinical Oncology Center · Phase 2, Interventional, and Treatment
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.
6,541 studies on the registry are indexed under Colorectal Neoplasms; 1,667 are open to participants now.
This study's planned enrollment of 160 is above the median of 76 across 4,800 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →Nizhny Novgorod Regional Clinical Oncology Center is the lead sponsor of 3 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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).
Drug: Capecitabine
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).
Drug: Capecitabine · Drug: Oxaliplatin
Capecitabine 2000mg/m2 from day 1 to 14
Oxaliplatin 130mg/m2 on day 1, cycle of 21 days
The disease free survival
Time from randomization to disease recurrence
Time frame: 3 years
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.
Time frame: 5 years
Аssessment of the quality of life
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).
Time frame: 5 years
Toxicity assessment
Treatment toxicity according to common terminology criteria for adverse events version 5.0
Time frame: 6 months
Plan to share: No
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Studies of the drug tested here: Capecitabine
Nizhny Novgorod Regional Clinical Oncology Center