Metastatic Colorectal CancerPhase 2NCT05316818
Triplet (FOLFOXIRI) vs. Doublet (FOLFOX or FOLFIRI) Regimen as a 1st Line Treatment in Metastatic Colorectal Carcinoma
A Phase 2 study testing FOLFOXIRI Protocol in people with Metastatic Colorectal Cancer, run by Kasr El Aini Hospital at 1 site in Egypt.
Trial summary
This is a prospective randomized phase II trial was done in clinical oncology department at Kasr Alainy hospital, Cairo university (NEMROCK) to evaluate the role of intensification of chemotherapy in the first line for treatment of metastatic colorectal carcinoma by adding third agent to standard doublet regimen on… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Metastatic Colorectal Cancer
- What is being tested?
- FOLFOXIRI Protocol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteEgypt
- Study dates
- 16 Jan 2018to 10 Apr 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with histologically proven adenocarcinoma of the colon or rectum, with unresectable measurable metastatic disease
- No previous treatment for the metastatic disease was allowed, only previously fluoropyrimidine-based adjuvant chemotherapy was allowed if ended more than 6 months before enrollment in the study
- Adequate haematological parameters (leukocyte count of at least 3,500/mm₃, neutrophil count of at least 1,500/ mm and platelet count of at least 100,000/mm
- Adequate liver and renal function parameters (serum creatinine ≤ 1.3 mg/dL, serum bilirubin ≤ 1.5 mg/dL and AST, ALT and alkaline phosphatase 2.5 x upper normal values or less.
- Patient had no co-morbidity disease
Who cannot join
- Poor performance status 3-4 according to ECOG score, prior chemotherapy for advanced, recurrent or metastatic disease, other simultaneous malignancies and pregnant or lactating female
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Efficacy and Toxicity of Triplet Regimen (FOLFOXIRI) Versus Doublet Regimen (FOLFOX or FOLFIRI) as First Line Treatment in Locally Advanced, Recurrent or Metastatic Colorectal Carcinoma.
This is a prospective randomized phase II trial was done in clinical oncology department at Kasr Alainy hospital, Cairo university (NEMROCK) to evaluate the role of intensification of chemotherapy in the first line for treatment of metastatic colorectal carcinoma by adding third agent to standard doublet regimen on oncological outcomes \& assess tolerance to the intensified treatment
Read the detailed description
Patients with histologically proven adenocarcinoma of the colon or rectum, with unresectable measurable metastatic disease, were enrolled and randomized in a 1:1 ratio.
Patients were assigned to receive FOLFOXIRI (experimental arm) or FOLFIRI or FOLFOX4 (control arm) biweekly up to 12 cycles.
Randomization was done by enclosed envelope method Evaluation of the patients for surgical resection of residual metastases was done every 12 weeks. In the case of secondary resection of metastases, patients completed with the same chemotherapy regimen received before resection up to 12 cycles Maintenance therapy with capecitabine for 6 months was administered for patients who achieved complete or partial tumor response. In case of disease progression, second line chemotherapy was then administered in both groups until tumor progression, the occurrence of an unacceptable adverse event, or patient refusal
- Conditions
- Metastatic Colorectal Cancer
- Being tested
- FOLFOXIRI Protocol
- Keywords
- First line chemotherapy, FOLFOXIRI, standard doublet, Efficacy, Toxicity
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FOLFOXIRI ProtocolDrug
Triplet chemotherapy regimen consists from active three cytotoxic agents aiming to improve outcomes
| Study group | Role | What they receive |
|---|---|---|
| Triplet regimen (FOLFOXIRI) | Experimental | The treatment planned consisted of irinotecan 160 mg/m² in 250 ml of NaCl 0.9% over 1 hr, followed by 85 mg/m² oxaliplatin in 250 ml dextrose 5% given concurrently with a 400 mg/m² leucovorin intra venous infusion in 250 ml dextrose 5% for 120 min, followed by 2400 mg/m² for 44-hr continuous infusion Receives: Drug: FOLFOXIRI Protocol |
| standard duplet regimen (FOLFOX or FOLFIRI) | Active comparator | Regimen consisted of 180 mg/m² intravenous infusion of irinotecan for 60 min OR 85 mg/m² oxaliplatin day 1 only followed by a 200 mg/m² intra venous infusion of leucovorin for 120 min, a 400 mg/m² intravenous bolus of fluorouracil, and a 600 mg/m² continuous infusion of fluorouracil for 22 hr to be repeated on day 2 Receives: Drug: FOLFOXIRI Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate (ORR)
the percentage of patients, relative to the total of enrolled subjects, achieving a complete (CR) or partial (PR) response, according to RECIST 1.1 criteria
Measured: 6 months ( from staring treatment till finishing 12 cycles, each cycle every 2 weeks)
Rate of adverse events
Adverse events (haematological \& non-haematological) were assessed before each cycle using the Common Terminology Criteria for Adverse Events version (CTCAE) 5.0, 2017 with scale from (G0-5) for each event.
Measured: During the study treatment period till 30 days following the end of therapy
Secondary outcomes (2)
Progression free survival (PFS)
the time from randomization to the first documentation of objective disease progression or death due to any cause, whichever occurs first. Documentation of disease progressive disease is defined as per RECIST 1.1 criteria based on investigator assessment
Measured: 18 months
Overall survival time (OS)
Defined as the length of time from date of randomization to the date of death due to any cause or due to lost follow up
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2022
- Study start16 Jan 2018
- Primary completion1 Dec 2020
- Study completion10 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Colorectal CancerStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Khaled Ahmed Khalil Hassan, Kasr El Aini Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05316818
- Sponsor's protocol ID
- I-160317
- Status last verified
- Mar 2022
- First submitted
- 7 Mar 2022
- Last updated
- 7 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Toxicity of Triplet Regimen (FOLFOXIRI) Versus Doublet Regimen (FOLFOX or FOLFIRI) as First Line Treatment in Locally Advanced, Recurrent or Metastatic Colorectal Carcinoma.
- ClinicalTrials.gov ID
- NCT05316818
- Acronym / sponsor ID
- I-160317
- Conditions
- Metastatic Colorectal Cancer
- Keywords
- First line chemotherapy, FOLFOXIRI, standard doublet, Efficacy, Toxicity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- 16 Jan 2018 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 10 Apr 2021 (actual)
- First posted
- 7 Apr 2022 (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 is a prospective randomized phase II trial was done in clinical oncology department at Kasr Alainy hospital, Cairo university (NEMROCK) to evaluate the role of intensification of chemotherapy in the first line for treatment of metastatic colorectal carcinoma by adding third agent to standard doublet regimen on oncological outcomes \& assess tolerance to the intensified treatment
Detailed description
Patients with histologically proven adenocarcinoma of the colon or rectum, with unresectable measurable metastatic disease, were enrolled and randomized in a 1:1 ratio.
Patients were assigned to receive FOLFOXIRI (experimental arm) or FOLFIRI or FOLFOX4 (control arm) biweekly up to 12 cycles.
Randomization was done by enclosed envelope method Evaluation of the patients for surgical resection of residual metastases was done every 12 weeks. In the case of secondary resection of metastases, patients completed with the same chemotherapy regimen received before resection up to 12 cycles Maintenance therapy with capecitabine for 6 months was administered for patients who achieved complete or partial tumor response. In case of disease progression, second line chemotherapy was then administered in both groups until tumor progression, the occurrence of an unacceptable adverse event, or patient refusal
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Triplet regimen (FOLFOXIRI) | Experimental | Drug: FOLFOXIRI ProtocolThe treatment planned consisted of irinotecan 160 mg/m² in 250 ml of NaCl 0.9% over 1 hr, followed by 85 mg/m² oxaliplatin in 250 ml dextrose 5% given concurrently with a 400 mg/m² leucovorin intra venous infusion in 250 ml dextrose 5% for 120 min, followed by 2400 mg/m² for 44-hr continuous infusion |
| standard duplet regimen (FOLFOX or FOLFIRI) | Active comparator | Drug: FOLFOXIRI ProtocolRegimen consisted of 180 mg/m² intravenous infusion of irinotecan for 60 min OR 85 mg/m² oxaliplatin day 1 only followed by a 200 mg/m² intra venous infusion of leucovorin for 120 min, a 400 mg/m² intravenous bolus of fluorouracil, and a 600 mg/m² continuous infusion of fluorouracil for 22 hr to be repeated on day 2 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients with histologically proven adenocarcinoma of the colon or rectum, with unresectable measurable metastatic disease
- No previous treatment for the metastatic disease was allowed, only previously fluoropyrimidine-based adjuvant chemotherapy was allowed if ended more than 6 months before enrollment in the study
- Adequate haematological parameters (leukocyte count of at least 3,500/mm₃, neutrophil count of at least 1,500/ mm and platelet count of at least 100,000/mm
- Adequate liver and renal function parameters (serum creatinine ≤ 1.3 mg/dL, serum bilirubin ≤ 1.5 mg/dL and AST, ALT and alkaline phosphatase 2.5 x upper normal values or less.
- Patient had no co-morbidity disease
Key exclusion criteria (1 listed)
- Poor performance status 3-4 according to ECOG score, prior chemotherapy for advanced, recurrent or metastatic disease, other simultaneous malignancies and pregnant or lactating female
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 |
|---|---|---|
| FOLFOXIRI ProtocolTriplet chemotherapy regimen consists from active three cytotoxic agents aiming to improve outcomes | Drug | Triplet regimen (FOLFOXIRI), standard duplet regimen (FOLFOX or FOLFIRI) |
Primary outcome
Overall response rate (ORR)
Time frame: 6 months ( from staring treatment till finishing 12 cycles, each cycle every 2 weeks)
the percentage of patients, relative to the total of enrolled subjects, achieving a complete (CR) or partial (PR) response, according to RECIST 1.1 criteria
Rate of adverse events
Time frame: During the study treatment period till 30 days following the end of therapy
Adverse events (haematological \& non-haematological) were assessed before each cycle using the Common Terminology Criteria for Adverse Events version (CTCAE) 5.0, 2017 with scale from (G0-5) for each event.
2 secondary outcomes
Progression free survival (PFS)
Time frame: 18 months
Overall survival time (OS)
Time frame: 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2022.
- Individual participant dataSharing planned: No
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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. 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 FOLFOXIRI Protocol in people with Metastatic Colorectal Cancer, run by Kasr El Aini Hospital 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 5 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: finished, as of the sponsor's last update on 7 Apr 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Overall response rate (ORR) (time frame: 6 months ( from staring treatment till finishing 12 cycles, each cycle every 2 weeks)). The study lists 2 primary outcomes in all. 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 7 Apr 2022.