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

NCT ID: NCT07215936

Last Updated: 2025-10-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-25

Study Completion Date

2028-09-30

Brief Summary

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Dose\_dense Capecitabine Schedule in colorectal cancers

Detailed Description

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Dose\_dense Capecitabine schedule\[7 days on\_7days off\] in colorectal cancer in comparison with standerd regimen

Conditions

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Colorectal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Dose\_dense capecitabine schedule \[7 days on \_7 days off \] Compared to standerd regimen
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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

Group Type ACTIVE_COMPARATOR

Arm A:Dose_dense Capecitabine in Colorectal cancer

Intervention Type DRUG

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

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

Group Type ACTIVE_COMPARATOR

Arm B : standard dose Capecitabine

Intervention Type DRUG

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

Interventions

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Arm A:Dose_dense Capecitabine in Colorectal cancer

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

Intervention Type DRUG

Arm B : standard dose Capecitabine

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* pateints with other malignancy Pateints who have other comorbid diseas
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sohag University

OTHER

Sponsor Role lead

Responsible Party

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Aliaa Alaa Abdelrahman

Assisstant lectular of clinical oncology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Sohag university hospital

Sohag, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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Soh_med_25_9___4MD

Identifier Type: -

Identifier Source: org_study_id

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