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. (AHTCRR-1)

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).

Study Overview

• Status: Recruiting
• Conditions: Colorectal Cancer
• Intervention / Treatment: Drug: Capecitabine; Drug: Oxaliplatin

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.

• Study Type: Interventional
• Enrollment (Estimated): 160
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Arina Datsyuk; Phone Number: +79049209496; Email: doc70doc@yandex.ru
• Study Contact Backup: Name: MIKHAIL OSIPOV; Phone Number: +79052075653; Email: ocipovmixail@mail.ru

Study Locations

• Russian Federation
  • Nizhny Novgorod, Russian Federation, 603126
    • Recruiting
    • RESEARCH INSTITUTE OF CLINICAL ONCOLOGY "NIZHNY NOVGOROD REGIONAL CLINICAL ONCOLOGICAL DISPENSARY"
    • Contact: Arina Datsuyk; Phone Number: +79049209496; Email: doc70doc@yandex.ru

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age 70 years and older;
2. Obtaining informed consent to participate in the study;
3. Morphologically confirmed diagnosis of colorectal cancer;
4. Stage III colorectal cancer;
5. Underwent radical surgical intervention for primary colorectal tumor;
6. ECOG score of 0 - I;
7. Life expectancy of more than 6 months;
8. No history of systemic drug therapy for CRC;
9. Adequate liver, kidney and bone marrow function;
10. Absence of severe uncontrolled concomitant chronic diseases and acute illnesses.

Exclusion Criteria:

1. Having previously received any systemic therapy for CRC;
2. Time after surgical treatment of more than 12 weeks;
3. Stage I-II and IV disease;
4. 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)]);
5. Severe uncontrolled comorbid chronic diseases or acute illnesses;
6. Presence of a second malignancy (except for previously cured malignancies);
7. Any condition that, in the opinion of the physician, would interfere with the study procedures.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fluoropyrimidines in mono-regimen; 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; Capecitabine 2000mg/m2 from day 1 to 14
Experimental: Combination chemotherapy based on platinum preparations; 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; Capecitabine 2000mg/m2 from day 1 to 14; Drug: Oxaliplatin; Oxaliplatin 130mg/m2 on day 1, cycle of 21 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The disease free survival	Time from randomization to disease recurrence	3 years

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Nizhny Novgorod Regional Clinical Oncology Center
• Investigators: Study Director: Sergey Gamayunov, DMS, Study Director

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2025
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2028

Study Registration Dates

• First Submitted: March 6, 2025
• First Submitted That Met QC Criteria: March 14, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 27, 2025
• Last Update Submitted That Met QC Criteria: March 24, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Capecitabine; Overall survival; XELOX; Disease free survival; Toxicity profile; Comprehensive geriatric evaluation
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Colorectal Neoplasms; Antineoplastic Agents; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Capecitabine; Oxaliplatin
• Other Study ID Numbers: CRR-2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No