Metastatic Colorectal Carcinoma (mCRC)NCT07334587
Comparison of Efficacy and Safety Between FOLFOX-6 and CAPOX in Metastatic Colorectal Carcinoma
A study testing Capecitabine and Oxaliplatin and Fluorouracil, Leucovorin Calcium, and Oxaliplatin in people with Metastatic Colorectal Carcinoma (mCRC), run by Allama Iqbal Medical College at 1 site in Pakistan.
Trial summary
This randomized controlled trial is designed to compare the efficacy and safety of two commonly used chemotherapy regimens, FOLFOX-6 and CAPOX, in adults with metastatic colorectal carcinoma who are receiving chemotherapy after surgery at the Department of Oncology, Jinnah Hospital, Lahore. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Metastatic Colorectal Carcinoma (mCRC)
- What is being tested?
- Capecitabine and Oxaliplatin and Fluorouracil, Leucovorin Calcium, and Oxaliplatin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 248 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Sep 2025to 28 Feb 2026
- Phase
- Interventional
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 20-70 years,
- Both genders,
- Diagnosed with metastatic colorectal carcinoma, receiving chemotherapy after surgery.
Who cannot join
- Patients with non-metastatic disease at the time of diagnosis, coexisting other malignancy, and administration of adjuvant chemotherapy in an external center
- Patients with a history of neurologic disease (as per medical record)
- Patients already taking trial treatment or enrolled in another trial
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site
Allama Iqbal Medical College, Lahore
Lahore, Punjab Province, 54000
About this study
This randomized controlled trial is designed to compare the efficacy and safety of two commonly used chemotherapy regimens, FOLFOX-6 and CAPOX, in adults with metastatic colorectal carcinoma who are receiving chemotherapy after surgery at the Department of Oncology, Jinnah Hospital, Lahore. A total of 248 eligible patients aged 20 to 70 years will be enrolled using consecutive sampling and randomly allocated in equal numbers to receive either CAPOX or FOLFOX-6 according to standard dosing schedules. Participants will be followed for 3 months to determine whether meaningful differences exist between the two regimens in clinically important outcomes. The primary comparison will focus on disease progression within the follow-up period. Additional safety and treatment feasibility outcomes will include the need for chemotherapy dose reduction due to toxicity, treatment discontinuation, hepatotoxicity based on liver function abnormalities, diarrhea persisting for more than 3 days, and mortality during follow-up. The study hypothesis is that the outcomes of FOLFOX-6 and CAPOX differ in terms of effectiveness and adverse effects. The findings are expected to inform selection of a regimen that provides better disease control with fewer treatment-limiting side effects in the local clinical setting.
- Conditions
- Metastatic Colorectal Carcinoma (mCRC)
- Being tested
- Capecitabine and Oxaliplatin, Fluorouracil, Leucovorin Calcium, and Oxaliplatin
- Keywords
- Oxaliplatin, Metastatic colorectal cancer, Fluorouracil, Antineoplastic combined chemotherapy, 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.
Capecitabine and OxaliplatinDrug
Also called Fluoropyrimidine-based chemotherapy with platinum compound
Oxaliplatin 130 mg per square meter administered intravenously on Day 1, together with oral capecitabine 1000 mg per square meter every 12 hours from Day 1 to Day 14.
The treatment cycle will be repeated every 21 days for 6 to 8 cycles.
Fluorouracil, Leucovorin Calcium, and OxaliplatinDrug
Also called Oxaliplatin-based infusional fluoropyrimidine chemotherapy regimen
Oxaliplatin 85 mg per square meter administered intravenously, leucovorin calcium 400 mg per square meter intravenous infusion, followed by fluorouracil bolus and continuous fluorouracil infusion over 46 hours at a dose of 2400 mg per square meter.
The regimen will be repeated every 14 days for 12 cycles.
| Study group | Role | What they receive |
|---|---|---|
| Group CAPOX | Experimental | Participants will receive combination chemotherapy with capecitabine and oxaliplatin following standard dosing schedule after surgical management of metastatic colorectal carcinoma. Receives: Drug: Capecitabine and Oxaliplatin |
| Group FOLFOX-6 | Active comparator | Participants will receive combination chemotherapy with fluorouracil, leucovorin calcium, and oxaliplatin following standard FOLFOX-6 protocol after surgical management of metastatic colorectal carcinoma. Receives: Drug: Fluorouracil, Leucovorin Calcium, and Oxaliplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease progression
Disease progression will be defined as an increase in lesion size and/or development of new symptoms consistent with worsening metastatic colorectal carcinoma, assessed clinically and by available follow-up evaluation during the follow-up period, as per the study operational definition.
Measured: Within 3 months after initiation of assigned chemotherapy regimen
Secondary outcomes (4)
Hepatotoxicity
Hepatotoxicity will be defined as alanine aminotransferase and aspartate aminotransferase levels greater than two times the upper limit of normal and/or total bilirubin level greater than 5 milli-international units, occurring during follow-up, as per operational definition.
Measured: ithin 3 months after initiation of assigned chemotherapy regimen
Diarrhea
Diarrhea will be defined as loose, watery stools persisting for more than 3 days during the follow-up period.
Measured: Within 3 months after initiation of assigned chemotherapy regimen
Discontinuation of chemotherapy
Permanent stopping of the assigned chemotherapy regimen due to severe adverse effects during the follow-up period.
Measured: Within 3 months after initiation of assigned chemotherapy regimen
All-cause mortality
Death from any cause occurring during the 3-month follow-up period after initiation of chemotherapy.
Measured: Within 3 months after initiation of assigned chemotherapy regimen
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2026
- Study start1 Sep 2025
- Primary completion28 Feb 2026 (estimated)
- Study completion28 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Colorectal Carcinoma (mCRC)Studies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 248 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Allama Iqbal Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Parnia Ansari, Allama Iqbal Medical College
- Investigators
- Parnia Ansari, Principal investigator, Allama Iqbal Medical College, Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07334587
- Sponsor's protocol ID
- AllamaIqbalMC1
- Status last verified
- Dec 2025
- First submitted
- 31 Dec 2025
- Last updated
- 12 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Efficacy and Safety Between FOLFOX-6 and CAPOX in Metastatic Colorectal Carcinoma
- ClinicalTrials.gov ID
- NCT07334587
- Acronym / sponsor ID
- AllamaIqbalMC1
- Conditions
- Metastatic Colorectal Carcinoma (mCRC)
- Keywords
- Oxaliplatin, Metastatic colorectal cancer, Fluorouracil, Antineoplastic combined chemotherapy, Capecitabine
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 248 participants (estimated)
- Lead sponsor
- Allama Iqbal Medical CollegeUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 28 Feb 2026 (estimated)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 12 Jan 2026 (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.
This randomized controlled trial is designed to compare the efficacy and safety of two commonly used chemotherapy regimens, FOLFOX-6 and CAPOX, in adults with metastatic colorectal carcinoma who are receiving chemotherapy after surgery at the Department of Oncology, Jinnah Hospital, Lahore. A total of 248 eligible patients aged 20 to 70 years will be enrolled using consecutive sampling and randomly allocated in equal numbers to receive either CAPOX or FOLFOX-6 according to standard dosing schedules. Participants will be followed for 3 months to determine whether meaningful differences exist between the two regimens in clinically important outcomes. The primary comparison will focus on disease progression within the follow-up period. Additional safety and treatment feasibility outcomes will include the need for chemotherapy dose reduction due to toxicity, treatment discontinuation, hepatotoxicity based on liver function abnormalities, diarrhea persisting for more than 3 days, and mortality during follow-up. The study hypothesis is that the outcomes of FOLFOX-6 and CAPOX differ in terms of effectiveness and adverse effects. The findings are expected to inform selection of a regimen that provides better disease control with fewer treatment-limiting side effects in the local clinical setting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group CAPOX | Experimental | Drug: Capecitabine and OxaliplatinParticipants will receive combination chemotherapy with capecitabine and oxaliplatin following standard dosing schedule after surgical management of metastatic colorectal carcinoma. |
| Group FOLFOX-6 | Active comparator | Drug: Fluorouracil, Leucovorin Calcium, and OxaliplatinParticipants will receive combination chemotherapy with fluorouracil, leucovorin calcium, and oxaliplatin following standard FOLFOX-6 protocol after surgical management of metastatic colorectal carcinoma. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients aged 20-70 years,
- Both genders,
- Diagnosed with metastatic colorectal carcinoma, receiving chemotherapy after surgery.
Key exclusion criteria (3 listed)
- Patients with non-metastatic disease at the time of diagnosis, coexisting other malignancy, and administration of adjuvant chemotherapy in an external center
- Patients with a history of neurologic disease (as per medical record)
- Patients already taking trial treatment or enrolled in another trial
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 |
|---|---|---|
| Capecitabine and OxaliplatinAlso: Fluoropyrimidine-based chemotherapy with platinum compoundOxaliplatin 130 mg per square meter administered intravenously on Day 1, together with oral capecitabine 1000 mg per square meter every 12 hours from Day 1 to Day 14. The treatment cycle will be repeated every 21 days for 6 to 8 cycles. | Drug | Group CAPOX |
| Fluorouracil, Leucovorin Calcium, and OxaliplatinAlso: Oxaliplatin-based infusional fluoropyrimidine chemotherapy regimenOxaliplatin 85 mg per square meter administered intravenously, leucovorin calcium 400 mg per square meter intravenous infusion, followed by fluorouracil bolus and continuous fluorouracil infusion over 46 hours at a dose of 2400 mg per square meter. The regimen will be repeated every 14 days for 12 cycles. | Drug | Group FOLFOX-6 |
Primary outcome
Disease progression
Time frame: Within 3 months after initiation of assigned chemotherapy regimen
Disease progression will be defined as an increase in lesion size and/or development of new symptoms consistent with worsening metastatic colorectal carcinoma, assessed clinically and by available follow-up evaluation during the follow-up period, as per the study operational definition.
4 secondary outcomes
Hepatotoxicity
Time frame: ithin 3 months after initiation of assigned chemotherapy regimen
Diarrhea
Time frame: Within 3 months after initiation of assigned chemotherapy regimen
Discontinuation of chemotherapy
Time frame: Within 3 months after initiation of assigned chemotherapy regimen
All-cause mortality
Time frame: Within 3 months after initiation of assigned chemotherapy regimen
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 12 Jan 2026.
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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.
Parnia Ansari principal investigator
Allama Iqbal Medical College, Lahore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Capecitabine and Oxaliplatin and Fluorouracil, Leucovorin Calcium, and Oxaliplatin in people with Metastatic Colorectal Carcinoma (mCRC), run by Allama Iqbal Medical College at 1 site in Pakistan.
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 3 inclusion and 3 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: enrolling by invitation, as of the sponsor's last update on 12 Jan 2026. 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 Pakistan. 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.
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?
Disease progression (time frame: Within 3 months after initiation of assigned chemotherapy regimen). 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 12 Jan 2026.