Colorectal CancerPhase 2NCT07215936
Dose-dense Capecitabine Schedule [7days on _7 Days Off] in Colorectal Cancer in Comparison With Standered Regimen
A Phase 2 study testing Arm A:Dose_dense Capecitabine in Colorectal cancer and Arm B : standard dose Capecitabine in people with Colorectal Cancer, run by Sohag University at 1 site in Egypt.
Trial summary
Dose_dense Capecitabine Schedule in colorectal cancers Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Arm A:Dose_dense Capecitabine in Colorectal cancer and Arm B : standard dose Capecitabine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Sep 2025to Sep 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients who diagnosed colorectal cancer Performance status ranging from 0 to 2 Both sexs
Who cannot join
- pateints with other malignancy Pateints who have other comorbid diseas
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dose_dense Capecitabine Schedule [7days on _7days Off] in Colorectal Cancer in Comparison With Standered Regimen
Dose_dense Capecitabine Schedule in colorectal cancers
Read the detailed description
Dose_dense Capecitabine schedule[7 days on_7days off] in colorectal cancer in comparison with standerd regimen
- Conditions
- Colorectal Cancer
- Being tested
- Arm A:Dose_dense Capecitabine in Colorectal cancer, Arm B : standard dose Capecitabine
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arm A:Dose_dense Capecitabine in Colorectal cancerDrug
Appling dose _dense Capecitabine 1750mg/m2 for one week then one week off Cycle repeated every 2 weeks
Arm B : standard dose CapecitabineDrug
Pateints will receive capecitabine 1000 mg/m2 for 2 weeks then one week off
| Study group | Role | What they receive |
|---|---|---|
| Arm A :will receive capecitabine dose dense 1750 mg /m2 7days on treatment and 7 days off | Active comparator | Not described Receives: 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 | Not described Receives: Drug: Arm B : standard dose Capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
1_Quality of life assessed through EORTC_QLQ_CR29 questionaire
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2025
- Study start25 Sep 2025
- Primary completionSep 2027 (estimated)
- Study completionSep 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.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- 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
- Dose\_dense capecitabine schedule \[7 days on \_7 days off \] Compared to standerd regimen
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aliaa Alaa Abdelrahman, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07215936
- Sponsor's protocol ID
- Soh_med_25_9___4MD
- Status last verified
- Oct 2025
- First submitted
- 4 Oct 2025
- Last updated
- 14 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose_dense Capecitabine Schedule [7days on _7days Off] in Colorectal Cancer in Comparison With Standered Regimen
- ClinicalTrials.gov ID
- NCT07215936
- Acronym / sponsor ID
- Soh_med_25_9___4MD
- Conditions
- Colorectal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 25 Sep 2025 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 14 Oct 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.
Dose_dense Capecitabine Schedule in colorectal cancers
Detailed description
Dose_dense Capecitabine schedule[7 days on_7days off] in colorectal cancer in comparison with standerd regimen
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Dose_dense capecitabine schedule [7 days on _7 days off ] Compared to standerd regimen
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients who diagnosed colorectal cancer Performance status ranging from 0 to 2 Both sexs
Key exclusion criteria (1 listed)
- pateints with other malignancy Pateints who have other comorbid diseas
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 |
|---|---|---|
| Arm A:Dose_dense Capecitabine in Colorectal cancerAppling dose _dense Capecitabine 1750mg/m2 for one week then one week off Cycle repeated every 2 weeks | Drug | Arm A :will receive capecitabine dose dense 1750 mg /m2 7days on treatment and 7 days off |
| Arm B : standard dose CapecitabinePateints will receive capecitabine 1000 mg/m2 for 2 weeks then one week off | Drug | Arm B will receive capecitabine standard dose 1000mg/m2 2weeks on and 1 week off |
Primary outcome
1_Quality of life assessed through EORTC_QLQ_CR29 questionaire
Time frame: 2 years
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 14 Oct 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Colorectal Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Arm A:Dose_dense Capecitabine in Colorectal cancer and Arm B : standard dose Capecitabine in people with Colorectal Cancer, run by Sohag University at 1 site in Egypt.
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 1 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 14 Oct 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 Egypt. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1_Quality of life assessed through EORTC_QLQ_CR29 questionaire (time frame: 2 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 14 Oct 2025.