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
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