Dose-dense Capecitabine Schedule [7days on _7 Days Off] in Colorectal Cancer in Comparison With Standered Regimen

NCT07215936 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: Soh_med_25_9___4MD
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Dose\_dense Capecitabine Schedule in colorectal cancers

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• 1_Quality of life assessed through EORTC_QLQ_CR29 questionaire

  2 years

Study Arms (2)

Arm A :will receive capecitabine dose dense 1750 mg /m2 7days on treatment and 7 days off

ACTIVE COMPARATOR

Drug: Arm A:Dose_dense Capecitabine in Colorectal cancer

Arm B will receive capecitabine standard dose 1000mg/m2 2weeks on and 1 week off

ACTIVE COMPARATOR

Drug: Arm B : standard dose Capecitabine

Interventions

Arm A:Dose_dense Capecitabine in Colorectal cancer DRUG

Appling dose \_dense Capecitabine 1750mg/m2 for one week then one week off Cycle repeated every 2 weeks

Arm A :will receive capecitabine dose dense 1750 mg /m2 7days on treatment and 7 days off

Arm B : standard dose Capecitabine DRUG

Pateints will receive capecitabine 1000 mg/m2 for 2 weeks then one week off

Arm B will receive capecitabine standard dose 1000mg/m2 2weeks on and 1 week off

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients who diagnosed colorectal cancer Performance status ranging from 0 to 2 Both sexs

You may not qualify if:

• pateints with other malignancy Pateints who have other comorbid diseas

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Sohag university hospital

Sohag, Egypt

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Capecitabine

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assisstant lectular of clinical oncology

Model Details: Dose\_dense capecitabine schedule \[7 days on \_7 days off \] Compared to standerd regimen

Study Record Dates

• First Submitted: October 4, 2025
• First Posted: October 14, 2025
• Study Start: September 25, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2028
• Last Updated: October 14, 2025

Record last verified: 2025-10

Locations

EG (1)