Colorectal CancerPhase 2AHTCRR-1NCT06888843
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.
A Phase 2 study testing Capecitabine and Oxaliplatin in people with Colorectal Cancer, run by Nizhny Novgorod Regional Clinical Oncology Center at 1 site in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 70 to 90 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Capecitabine and Oxaliplatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteRussia
- Study dates
- 1 Feb 2025to 1 Feb 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 to 90 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Russia1 site, 1 recruiting
- Recruiting
Research Institute of Clinical Oncology "Nizhny Novgorod Regional Clinical Oncological Dispensary"
Nizhny Novgorod, 603126
Arina Datsuyk, +79049209496, doc70doc@yandex.ru
About this study
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.
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).
Read the 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
- Capecitabine in mono-regimen
- 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.
- Conditions
- Colorectal Cancer
- Being tested
- Capecitabine, Oxaliplatin
- Keywords
- XELOX, Capecitabine, Overall survival, Disease free survival, Toxicity profile, Comprehensive geriatric evaluation
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CapecitabineDrug
Capecitabine 2000mg/m2 from day 1 to 14
OxaliplatinDrug
Oxaliplatin 130mg/m2 on day 1, cycle of 21 days
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Drug: Capecitabine |
| 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). Receives: Drug: Capecitabine; Drug: Oxaliplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The disease free survival
Time from randomization to disease recurrence
Measured: 3 years
Secondary outcomes (3)
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.
Measured: 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).
Measured: 5 years
Toxicity assessment
Treatment toxicity according to common terminology criteria for adverse events version 5.0
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2025
- Study start1 Feb 2025
- Primary completion1 Feb 2028 (estimated)
- Study completion1 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nizhny Novgorod Regional Clinical Oncology Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Sergey Gamayunov, DMS, Study director, Study Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06888843
- Sponsor's protocol ID
- CRR-2025
- Acronym
- AHTCRR-1
- Status last verified
- Mar 2025
- First submitted
- 6 Mar 2025
- Last updated
- 27 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06888843
- Acronym / sponsor ID
- AHTCRR-1 / CRR-2025
- Conditions
- Colorectal Cancer
- Keywords
- XELOX, Capecitabine, Overall survival, Disease free survival, Toxicity profile, Comprehensive geriatric evaluation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Nizhny Novgorod Regional Clinical Oncology CenterOther government
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 1 Feb 2028 (estimated)
- Study completion
- 1 Feb 2028 (estimated)
- First posted
- 21 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Capecitabine in mono-regimen
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Fluoropyrimidines in mono-regimen | Experimental | Drug: CapecitabineCapecitabine 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 | Drug: Capecitabine, Drug: OxaliplatinXELOX: 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). |
Who may qualify
- Ages
- 70 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (10 listed)
- 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;
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CapecitabineCapecitabine 2000mg/m2 from day 1 to 14 | Drug | Combination chemotherapy based on platinum preparations, Fluoropyrimidines in mono-regimen |
| OxaliplatinOxaliplatin 130mg/m2 on day 1, cycle of 21 days | Drug | Combination chemotherapy based on platinum preparations |
Primary outcome
The disease free survival
Time frame: 3 years
Time from randomization to disease recurrence
3 secondary outcomes
The overall survival
Time frame: 5 years
Аssessment of the quality of life
Time frame: 5 years
Toxicity assessment
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sergey Gamayunov, DMS study director
Study Director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Capecitabine and Oxaliplatin in people with Colorectal Cancer, run by Nizhny Novgorod Regional Clinical Oncology Center at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Arina Datsyuk (+79049209496, doc70doc@yandex.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The disease free survival (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2025.