Metastatic Colorectal CancerPhase 2NCT02128425
FOLFOXIRI Compared to FOLFOX in First Line Treatment of Metastatic Colorectal Cancer
A Phase 2 study testing FOLFOXIRI and FOLFOX in people with Metastatic Colorectal Cancer, run by Sun Yat-sen University at 1 site in China.
Trial summary
The purpose of the study is to evaluate if the exposure to all the three active cytotoxic agents (FOLFOXIRI regimen) is superior in terms of progression-free survival to conventional chemotherapy with the FOLFOX regimen as first-line treatment of chemo-naive metastatic colorectal cancer patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Metastatic Colorectal Cancer
- What is being tested?
- FOLFOXIRI and FOLFOX
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- 1 siteChina
- Study dates
- Apr 2014to Apr 2018
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent obtained before any study specific procedures. -Subjects must be able to understand and willing to sign a written informed consent.
- Male or female subjects ≥ 18 years ≤ 75 years of age
- Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 2.(ECOG PS 0-2 for≥18 years ≤ 65 years of age ，ECOG PS 0-1 for >65 years of age)
- Histological or cytological documentation of adenocarcinoma of the colon or rectum. All other histological types are excluded.
- There must be documentation by PET/CT scan, CT scan, MRI, or intraoperative palpation (at the time of resection of the primary colorectal tumor, if applicable) that the patient has evidence of metastases (Histologic confirmation of metastasis is not required.).
- At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria measured within 4 weeks prior to registration.
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- No previous chemotherapy or target therapy for metastatic disease (adjuvant chemotherapy for non-metastatic disease is allowed if terminated more than 6 months ago).
- In case of previous radiotherapy, at least one measurable lesion should be located outside the irradiated field.
- Adequate bone marrow, hepatic and renal function as assessed by the following laboratory requirements conducted within 7 days of starting study treatment:
- Leukocytes ≥ 3.0 x109/ L, absolute neutrophil count (ANC) ≥ 1.5 x109/ L, platelet count ≥ 100 x109/ L, hemoglobin (Hb) ≥9g/ dL.
- Total bilirubin ≤ 1.5 x the upper limit of normal (ULN).
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 5 x ULN.
- Alkaline phosphatase limit ≤ 5x ULN.
- Amylase and lipase ≤ 1.5 x the ULN.
- Serum creatinine ≤ 1.5 x the ULN.
- Calculated creatinine clearance or 24 hour creatinine clearance ≥ 50 mL/ min.
Who cannot join
- Previous palliative chemotherapy for metastatic disease，previous adjuvant chemotherapy including irinotecan or oxaliplatin within 6 months before random assignment.
- Previous or concurrent cancer that is distinct in primary site or histology from colorectal cancer within 5 years prior to randomization.
- Life expectancy > 12 weeks;
- Extended field radiotherapy within 4 weeks or limited field radiotherapy within 2 weeks prior to randomization. Subjects must have recovered from all therapy-related toxicities.
- Major surgical procedure, open biopsy, or significant traumatic injury within 4 weeks before start of study medication.
- Congestive heart failure ≤ New York Heart Association (NYHA) class 2.
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- Significant cardiovascular disease including unstable angina or myocardial infarction within 6 months before initiating study treatment or a history of ventricular arrhythmia
- Arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within the 6 months before start of study medication.
- Any evidence of active infection.
- History of interstitial pneumonitis or pulmonary fibrosis
- Pregnancy or lactation at the time of study entry.
- Known dihydropyrimidine dehydrogenase (DPD) deficiency
- Any illness or medical conditions that are unstable or could jeopardize the safety of the subjects and his/her compliance in the study.
- Active inflammatory bowel disease or other bowel disease causing chronic diarrhoea
- Subjects with known allergy to the study drugs or to any of its excipients.
- Current or recent (within 4 weeks prior to starting study treatment) treatment of another investigational drug or participation in another investigational study.
- Continuous use of immunosuppressive agents (except the use of corticosteroids as anti-emetic prophylaxis/treatment).
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Gastrointestinal Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510655
Yanhong Deng, M.D., 008613925106525, 13925106525@163.com
Yanhong Deng, M.D.
About this study
Official title: Phase II Randomized Controlled Trial of FOLFOXIRI Compared to FOLFOX in First Line Treatment of Chemo-naive Metastatic Colorectal Cancer
The purpose of the study is to evaluate if the exposure to all the three active cytotoxic agents (FOLFOXIRI regimen) is superior in terms of progression-free survival to conventional chemotherapy with the FOLFOX regimen as first-line treatment of chemo-naive metastatic colorectal cancer patients.
A second primary aim is to evaluate the response rate, safety and tolerability of the chemotherapy of FOLFOXIRI regimen in this patient population.
Patients will be randomized to two therapy groups:
Experimental arm A: Chemotherapy with FOLFOXIRI Standard arm B: Chemotherapy with FOLFOX
Read the detailed description
Survival of patients with metastatic colorectal cancer is correlated with the proportion of patients who receive all the three active drugs , but not with the proportion of patients who receive any second-line therapy. A superior efficacy in PFS,ORR and OS of FOLFOXIRI has been reported with acceptable toxicity. Moreover,evidence suggests that continuous dosing metronomic chemotherapy may be more efficacious than interval-chemotherapy.
Therefore, a way to improve the outcome of metastatic colorectal cancer patients could be to administer a maintenance first-line regimen containing the three active agents.
- Conditions
- Metastatic Colorectal Cancer
- Being tested
- FOLFOXIRI, FOLFOX
- Keywords
- Colorectal cancer, Metastatic colorectal cancer, FOLFOXIRI, FOLFOX, Oxaliplatin, irinotecan, Leucovorin, 5-FU
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FOLFOXIRIDrug
Also called Irinotecan, Oxaliplatin, Leucovorin, 5-Fluorouracil
irinotecan* 165 mg/m² + oxaliplatin 85 mg/m² + leucovorin 200 mg/m² + 5-FU 3200 mg/m² cont. inf. 46h all on day 1 of each 2 weeks cycle
*reduced in UGT1A1 7/7 patients
FOLFOXDrug
Also called Oxaliplatin, Leucovorin, 5-Fluorouracil
oxaliplatin 85 mg/m² + leucovorin 400 mg/m² +5-FU 400mg/m² bolus iv.+ 5-FU 2400 mg/m² cont. inf. 46h all on day 1 of each 2 weeks cycle
| Study group | Role | What they receive |
|---|---|---|
| FOLFOXIRI | Experimental | FOLFOXIRI Receives: Drug: FOLFOXIRI |
| FOLFOX | Active comparator | FOLFOX Receives: Drug: FOLFOX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival after induction and maintenance chemotherapy (PFS1)
Progressions are evaluated every 8 weeks according to WHO criteria and reviewed by an independent panel at the end of follow up (36 months).
Measured: up to 18 months
Secondary outcomes (7)
Progression-free survival after re-introduction of chemotherapy (PFS2)
Measured: up to 24 months
Response rate during re-introduction of chemotherapy
(CR + PR rate according to RECIST)
Measured: up to 12 months
Early tumor shrinkage rate in 8 weeks after induction treatment
Measured: 8 weeks
Overall survival
Measured: up to 5 years
toxicity and safety
Number of participants with adverse events as a measure of safety and tolerability according to NCI CTC 4.0
Measured: up to 24 months
QLQ (QLQ C30) - scores according to EORTC QLQ-C30 scoring manual (Quality of life)
Measured: up to 36 months
Translational research
Measured: up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2014 (estimated)
- Study startApr 2014
- Primary completionFeb 2017 (estimated)
- Study completionApr 2018 (estimated)
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.
- More trials run by Sun Yat-sen 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
- Masking
- None (open label)
- Enrolment
- 162 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanhong Deng, Sun Yat-sen University
- Investigators
- Yanhong Deng, M.D., Principal investigator, Sixth Affiliated Hospital, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02128425
- Sponsor's protocol ID
- GIHSYSU06
- Status last verified
- Apr 2014
- First submitted
- 15 Apr 2014
- Last updated
- 7 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Randomized Controlled Trial of FOLFOXIRI Compared to FOLFOX in First Line Treatment of Chemo-naive Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT02128425
- Acronym / sponsor ID
- GIHSYSU06
- Conditions
- Metastatic Colorectal Cancer
- Keywords
- Colorectal cancer, Metastatic colorectal cancer, FOLFOXIRI, FOLFOX, Oxaliplatin, irinotecan, Leucovorin, 5-FU
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 162 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Feb 2017 (estimated)
- Study completion
- Apr 2018 (estimated)
- First posted
- 1 May 2014 (estimated)
- 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.
The purpose of the study is to evaluate if the exposure to all the three active cytotoxic agents (FOLFOXIRI regimen) is superior in terms of progression-free survival to conventional chemotherapy with the FOLFOX regimen as first-line treatment of chemo-naive metastatic colorectal cancer patients.
A second primary aim is to evaluate the response rate, safety and tolerability of the chemotherapy of FOLFOXIRI regimen in this patient population.
Patients will be randomized to two therapy groups:
Experimental arm A: Chemotherapy with FOLFOXIRI Standard arm B: Chemotherapy with FOLFOX
Detailed description
Survival of patients with metastatic colorectal cancer is correlated with the proportion of patients who receive all the three active drugs , but not with the proportion of patients who receive any second-line therapy. A superior efficacy in PFS,ORR and OS of FOLFOXIRI has been reported with acceptable toxicity. Moreover,evidence suggests that continuous dosing metronomic chemotherapy may be more efficacious than interval-chemotherapy.
Therefore, a way to improve the outcome of metastatic colorectal cancer patients could be to administer a maintenance first-line regimen containing the three active agents.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FOLFOXIRI | Experimental | Drug: FOLFOXIRIFOLFOXIRI |
| FOLFOX | Active comparator | Drug: FOLFOXFOLFOX |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Signed informed consent obtained before any study specific procedures. -Subjects must be able to understand and willing to sign a written informed consent.
- Male or female subjects ≥ 18 years ≤ 75 years of age
- Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 2.(ECOG PS 0-2 for≥18 years ≤ 65 years of age ，ECOG PS 0-1 for >65 years of age)
- Histological or cytological documentation of adenocarcinoma of the colon or rectum. All other histological types are excluded.
- There must be documentation by PET/CT scan, CT scan, MRI, or intraoperative palpation (at the time of resection of the primary colorectal tumor, if applicable) that the patient has evidence of metastases (Histologic confirmation of metastasis is not required.).
Key exclusion criteria (17 listed)
- Previous palliative chemotherapy for metastatic disease，previous adjuvant chemotherapy including irinotecan or oxaliplatin within 6 months before random assignment.
- Previous or concurrent cancer that is distinct in primary site or histology from colorectal cancer within 5 years prior to randomization.
- Life expectancy > 12 weeks;
- Extended field radiotherapy within 4 weeks or limited field radiotherapy within 2 weeks prior to randomization. Subjects must have recovered from all therapy-related toxicities.
- Major surgical procedure, open biopsy, or significant traumatic injury within 4 weeks before start of study medication.
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 |
|---|---|---|
| FOLFOXIRIAlso: Irinotecan, Oxaliplatin, Leucovorin, 5-Fluorouracilirinotecan* 165 mg/m² + oxaliplatin 85 mg/m² + leucovorin 200 mg/m² + 5-FU 3200 mg/m² cont. inf. 46h all on day 1 of each 2 weeks cycle *reduced in UGT1A1 7/7 patients | Drug | FOLFOXIRI |
| FOLFOXAlso: Oxaliplatin, Leucovorin, 5-Fluorouraciloxaliplatin 85 mg/m² + leucovorin 400 mg/m² +5-FU 400mg/m² bolus iv.+ 5-FU 2400 mg/m² cont. inf. 46h all on day 1 of each 2 weeks cycle | Drug | FOLFOX |
Primary outcome
Progression-free survival after induction and maintenance chemotherapy (PFS1)
Time frame: up to 18 months
Progressions are evaluated every 8 weeks according to WHO criteria and reviewed by an independent panel at the end of follow up (36 months).
7 secondary outcomes
Progression-free survival after re-introduction of chemotherapy (PFS2)
Time frame: up to 24 months
Response rate during re-introduction of chemotherapy
Time frame: up to 12 months
Early tumor shrinkage rate in 8 weeks after induction treatment
Time frame: 8 weeks
Overall survival
Time frame: up to 5 years
toxicity and safety
Time frame: up to 24 months
QLQ (QLQ C30) - scores according to EORTC QLQ-C30 scoring manual (Quality of life)
Time frame: up to 36 months
Translational research
Time frame: up to 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2014.
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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.
Yanhong Deng, M.D. principal investigator
Sixth Affiliated Hospital, Sun Yat-sen University
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 and FOLFOX in people with Metastatic Colorectal Cancer, run by Sun Yat-sen University at 1 site in China.
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 16 inclusion and 17 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: status not confirmed, as of the sponsor's last update on 7 May 2014. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yanhong Deng, M.D. (008613925106525, 13925106525@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival after induction and maintenance chemotherapy (PFS1) (time frame: up to 18 months). 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 May 2014.