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.

NCT06888843 | Recruiting Phase 2

• 1 other identifier: CRR-2025
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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).

Conditions

Colorectal Cancer

Keywords

XELOX; Capecitabine; Overall survival; Disease free survival; Toxicity profile; Comprehensive geriatric evaluation

Outcome Measures

Primary Outcomes (1)

• The disease free survival

  Time from randomization to disease recurrence

  3 years

Secondary Outcomes (3)

• The overall survival

  5 years

• Аssessment of the quality of life

  5 years

• Toxicity assessment

  6 months

Study Arms (2)

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).

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).

Drug: Capecitabine; Drug: Oxaliplatin

Interventions

Capecitabine DRUG

Capecitabine 2000mg/m2 from day 1 to 14

Combination chemotherapy based on platinum preparations; Fluoropyrimidines in mono-regimen

Oxaliplatin DRUG

Oxaliplatin 130mg/m2 on day 1, cycle of 21 days

Combination chemotherapy based on platinum preparations

Eligibility Criteria

• Age: 70 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nizhny Novgorod Regional Clinical Oncology Center: lead

Study Sites (1)

Research Institute of Clinical Oncology "Nizhny Novgorod Regional Clinical Oncological Dispensary"

Nizhny Novgorod, 603126, Russia

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Capecitabine; Oxaliplatin

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Coordination Complexes; Organic Chemicals

Study Officials

• Sergey Gamayunov, DMS

  Study Director

  STUDY DIRECTOR

Central Study Contacts

Arina Datsyuk

CONTACT

+79049209496; doc70doc@yandex.ru

MIKHAIL OSIPOV

CONTACT

+79052075653; ocipovmixail@mail.ru

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 6, 2025
• First Posted: March 21, 2025
• Study Start: February 1, 2025
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2028
• Last Updated: March 27, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)