Metastatic Colorectal CancerPhase 3NCT01219920
FOLFOXIRI Compared With FOLFIRI for Metastatic Colorectal Cancer
A Phase 3 study testing FOLFIRI and FOLFOXIRI in people with Metastatic Colorectal Cancer, run by Gruppo Oncologico del Nord-Ovest at 48 sites in Italy.
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 response rate to conventional chemotherapy with the FOLFIRI regimen as first-line treatment of 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?
- FOLFIRI and FOLFOXIRI
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 244 participants
- Where
- 48 sitesItaly
- Study dates
- Nov 2001to Nov 2009
- Phase
- Phase 3
- 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
- adenocarcinoma of the colon or rectum
- unresectable metastatic disease
- age 18 to 75 years
- Eastern Cooperative Oncology Group (ECOG) performance status of 2 or lower if age 70 years or younger or ECOG performance status of 0 if age 71 to 75 years measurable disease according to WHOcriteria
- leukocyte count of at least 3,500/mm3, neutrophils count of at least 1,500/mm3, platelet count of at least 100,000/mm3
- serum creatinine of 1.3 mg/dL or less
- serum bilirubin less than 1.5 mg/dL and AST, ALT, and alkaline phosphatase 2.5 x normal values or less (</= 5 if liver metastases)
- previous fluoropyrimidine-based adjuvant chemotherapy was allowed if ended more than 6 months before random assignment
Who cannot join
- previous palliative chemotherapy for metastatic disease
- previous chemotherapy including irinotecan or oxaliplatin
- symptomatic cardiac disease, myocardial infarction in the last 24 months or uncontrolled arrhythmia
- active infections
- inflammatory bowel disease
- total colectomy
Trial locations and contacts
48 sites in 1 country.
48 sites in 1 country
Italy48 sites
Ospedale Civile Ss. Antonio E Biagio Di Alessandria - Alessandria (Al) Oncologia Medica
Alessandria, 15100
A.O. Universitaria Ospedali Riuniti - Ospedale Umberto I Di Ancona - Ancona (An) Oncologia Medica
Ancona, 60100
Ausl Della Valle D' Aosta (Ao) - Aosta (Ao) Oncologia Medica
Aosta, 11100
P.O. Zona Aretina - Ospedale S. Donato Di Arezzo - Arezzo (Ar) Oncologia Medica
Arezzo, 52100
Azienda Ospedale 'G.Rummo' - Benevento (Bn) Oncologia Medica
Benevento, 82100
Ospedale Degli Infermi Di Biella - Biella (Bi) Oncologia Medica
Biella, 13900
Ospedale S. Orsola F.B.F. - Brescia - Brescia (Bs) Oncologia Medica
Brescia, 25122
Stabilimento "Perrino" - Brindisi - Brindisi (Br) Oncologia Medica
Brindisi, 72100
Azienda Ospedaliera S. Elia - Caltanissetta (Cl) Oncologia Medica
Caltanissetta, 93100
Ospedale Versilia - Camaiore (Lu) Oncologia Medica
Camaiore, 55043
Ospedale Cecina - Cecina (Li) Oncologia Medica
Cecina, 57023
Istituti Ospitalieri - Cremona - Cremona (Cr) Oncologia Medica
Cremona, 26100
Azienda Ospedaliera S. Croce E Carle Di Cuneo - Cuneo (Cn) Oncologia Medica
Cuneo, 12100
Ausl 11 Di Empoli (Fi) - Empoli (Fi) Oncologia Medica
Empoli, 50053
Asur - Zona Territoriale 6 Di Fabriano (An) - Fabriano (An) Oncologia Medica
Fabriano, 60044
Ospedale Santa Croce Fano - Fano (Pu) Oncologia Medica
Fano, 61032
Ausl 10 Di Firenze - Firenze (Fi) Oncologia Medica
Florence, 50122
A.O. Universitaria Careggi Di Firenze Oncologia Medica
Florence, 50134
E.O. Ospedali Galliera - Genova (Ge) Oncologia Medica
Genova, 16128
Irccs Istituto Nazionale Per La Ricerca Sul Cancro (Ist) - Genova (Ge) Oncologia Medica
Genova, 16132
Ospedale Sant'Andrea La Spezia - La Spezia (Sp) Oncologia Medica
La Spezia, 19100
Ausl Le Di Lecce - Lecce (Le) Oncologia Chirurgica
Lecce, 73100
Ospedale Per Acuti "Mater Salutis" Legn. - Legnago (Vr) Oncologia Medica
Legnano, 37045
U.O. Oncologia Medica, Ospedale Civile
Livorno, 57123
Presidio Ospedaliero Piana Di Lucca - Lucca (Lu) Oncologia Medica
Lucca, 55100
Irccs Fondazione Centro S. Raffaele Del Monte Tabor - Milano (Mi) Oncologia Medica
Milan, 20132
Ospedale Ca' Granda-Niguarda - Milano - Milano (Mi) Oncologia Medica
Milan, 20162
Ospedale Civile Di Mirano - Mirano (Ve) Oncologia Medica
Mirano, 30035
A.O. Universitaria Federico Ii Di Napoli Oncologia Medica
Naples, 80131
A.O. Universitaria Maggiore Della Carita' Di Novara Oncologia Medica
Novara, 28100
A.O. Universitaria Di Parma Oncologia Medica
Parma, 43100
Asl 1 Di Citta' Di Castello (Pg) - Citta' Di Castello (Pg) Oncologia Medica
Perugia, 06012
A.O. Di Perugia - Ospedale S. Maria Della Misericordia (Ex Silvestrini) - Perugia (Pg) Oncologia Medica
Perugia, 06156
Azienda Ospedaliera San Salvatore - Pesaro (Pu) Oncologia Medica
Pesaro, 61100
Ospedale Piombino - Piombino (Li) Oncologia Medica
Piombino, 57025
Ausl 5 Di Pisa - Pisa (Pi) Oncologia Medica
Pisa, 56100
A.O. Universitaria Pisana - Pisa (Pi) Oncologia Medica
Pisa, 56126
A.O. Universitaria Pisana Oncologia Medica
Pisa, 56126
Ausl 3 Di Pistoia - Pistoia (Pt) Oncologia Medica
Pistoia, 51100
Ospedali Riuniti Di Pistoia - Pistoia (Pt) Oncologia Medica
Pistoia, 51100
Ospedale Di S. Maria Nuova - Reggio Nell'Emilia
Reggio Emilia, 42100
Policlinico Universitario Campus Bio-Medico Di Roma Oncologia Medica
Roma, 00128
Policlinico Umberto I Di Roma Oncologia Medica
Roma, 00161
Policlinico Universitario Gemelli Di Roma Oncologia Medica
Roma, 00168
A.O. Universitaria Senese Oncologia Medica
Siena, 53100
Ausl 7 Di Siena - Siena (Si) Oncologia Medica
Siena, 53100
Ospedale Civile - Sondrio - Sondrio (So) Oncologia Medica
Sondrio, 23100
A.O. Universitaria S. Giovanni Battista-Molinette Di Torino Oncologia Medica
Torino, 10134
About this study
Official title: Phase III Trial of Infusional Fluorouracil, Leucovorin, Oxaliplatin and Irinotecan (FOLFOXIRI) Compared With Infusional Fluorouracil, Leucovorin and Irinotecan (FOLFIRI) as First-line Treatment for 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 response rate to conventional chemotherapy with the FOLFIRI regimen as first-line treatment of metastatic colorectal cancer patients.
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 in the course of the disease, but not with the proportion of patients who receive any second-line therapy. In a sequential strategy, not all patients who progress after first-line chemotherapy are able to receive second-line treatment. Moreover, there is a correlation between the response rate to chemotherapy and the postchemotherapy radical resection rate of metastases.
Therefore, a way to improve the outcome of metastatic colorectal cancer patients could be to administer a first-line regimen containing the three active agents.
- Conditions
- Metastatic Colorectal Cancer
- Being tested
- FOLFIRI, FOLFOXIRI
- Keywords
- Metastatic colorectal cancer, Phase III, FOLFOXIRI, FOLFIRI
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FOLFIRIDrug
Also called Campto, l-lederfolin, 5-FU
Irinotecan 180 mg/sqm on day 1 Leucovorin 100 mg/sqm on day 1 and day 2 5-fluorouracil 400 mg/sqm bolus followed by 5-fluorouracil 600 mg/sqm 22-hour continuous infusion on day 1 and day 2 Repeated every 2 weeks
FOLFOXIRIDrug
Also called Campto, Eloxatin, l-leucovorin, 5FU
Irinotecan 165 mg/sqm on day 1 Oxaliplatin 85 mg/sqm on day 1 Leucovorin 200 mg/sqm on day 1 5-fluorouracil 3200 mg/sqm 48-hour continuous infusion starting on day 1 Repeated every 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| FOLFIRI | Active comparator | Irinotecan 180 mg/sqm on day 1 Leucovorin 100 mg/sqm on day 1 and day 2 5-fluorouracil 400 mg/sqm bolus followed by 5-fluorouracil 600 mg/sqm 22-hour continuous infusion on day 1 and day 2 Repeated every 2 weeks Receives: Drug: FOLFIRI |
| FOLFOXIRI | Experimental | Irinotecan 165 mg/sqm on day 1 Oxaliplatin 85 mg/sqm on day 1 Leucovorin 200 mg/sqm on day 1 5-fluorouracil 3200 mg/sqm 48-hour continuous infusion starting on day 1 Repeated every 2 weeks Receives: Drug: FOLFOXIRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate (RR)
Responses are evaluated every 8 weeks according to WHO criteria. The determination of responses and progression was initially based on investigator-reported measurements; computed tomography scans of all responding patients and of patients with stable disease were subsequently subjected to external review by an independent panel.
Measured: Responses are evaluated every 8 weeks according to WHO criteria and reviewed by an independent panel at the end of treatment (6 months)
Secondary outcomes (5)
Progression-free survival (PFS)
PFS is defined as the length of time from random assignment to disease progression or to death resulting from any cause, whichever occurred first, or to last contact.
Measured: Progressions are evaluated every 8 weeks according to WHO criteria and reviewed by an independent panel at the end of follow up (36 months)
Overall survival (OS)
OS is defined as the length of time from random assignment to death or to last contact.
Measured: For survival analysis participants are followed until death
Postchemotherapy radical (R0) surgical resection rate of metastases
Percentage of patients who undergo radical (R0) resection of metastases after achieving objective response to chemotherapy.
Measured: Postchemotherapy radical (R0) surgical resection rate of metastases were evaluated every 8 weeks during treatment and during follow up (36 months)
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
During the full lenght of first-line treatment, number of enrolled patients reporting adverse events is recorded. Adverse events are evaluated according to National Cancer Institute Common Toxicity Criteria version 2.0.
Measured: Number of Participants with Adverse Events as a Measure of Safety and Tolerability were evaluated every 2 weeks during treatment and every 8 weeks during follow up (36 months)
Quality of life (QoL)
Quality of life is assessed at the beginning of each treatment cycle using the Quality of Life Questionnaire of the European Organisation for Research and Treatment of Cancer (version 2.0).
The QLQ-C30 questionnaire was analyzed with the global health status/quality-of-life scale as the primary end point and the other 10 scales as secondary end points.
Measured: Quality of life was evaluated every 2 weeks during treatment and every 8 weeks during follow up (36 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2010 (estimated)
- Study startNov 2001
- Primary completionNov 2005
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 244 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gruppo Oncologico del Nord-Ovest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alfredo Falcone, MD, Principal investigator, University of Pisa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01219920
- Sponsor's protocol ID
- ASL601LIOM03
- Other IDs
- 2007-002886-11
- Status last verified
- Mar 2015
- First submitted
- 8 Oct 2010
- Last updated
- 11 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Falcone A, Ricci S, Brunetti I, Pfanner E, Allegrini G, Barbara C, Crino L, Benedetti G, Evangelista W, Fanchini L, Cortesi E, Picone V, Vitello S, Chiara S, Granetto C, Porcile G, Fioretto L, Orlandini C, Andreuccetti M, Masi G; Gruppo Oncologico Nord Ovest. Phase III trial of infusional fluorouracil, leucovorin, oxaliplatin, and irinotecan (FOLFOXIRI) compared with infusional fluorouracil, leucovorin, and irinotecan (FOLFIRI) as first-line treatment for metastatic colorectal cancer: the Gruppo Oncologico Nord Ovest. J Clin Oncol. 2007 May 1;25(13):1670-6. doi: 10.1200/JCO.2006.09.0928.
PubMed 17470860Masi G, Vasile E, Loupakis F, Bursi S, Ricci S, Petrini I, Fontana A, Allegrini G, Falcone A. Triplet combination of fluoropyrimidines, oxaliplatin, and irinotecan in the first-line treatment of metastatic colorectal cancer. Clin Colorectal Cancer. 2008 Jan;7(1):7-14. doi: 10.3816/CCC.2008.n.002.
PubMed 18279572Masi G, Loupakis F, Pollina L, Vasile E, Cupini S, Ricci S, Brunetti IM, Ferraldeschi R, Naso G, Filipponi F, Pietrabissa A, Goletti O, Baldi G, Fornaro L, Andreuccetti M, Falcone A. Long-term outcome of initially unresectable metastatic colorectal cancer patients treated with 5-fluorouracil/leucovorin, oxaliplatin, and irinotecan (FOLFOXIRI) followed by radical surgery of metastases. Ann Surg. 2009 Mar;249(3):420-5. doi: 10.1097/SLA.0b013e31819a0486.
PubMed 19247029Cremolini C, Loupakis F, Masi G, Lonardi S, Granetto C, Mancini ML, Chiara S, Moretto R, Rossini D, Vitello S, Allegrini G, Tonini G, Bergamo F, Tomasello G, Ronzoni M, Buonadonna A, Bustreo S, Barbara C, Boni L, Falcone A. FOLFOXIRI or FOLFOXIRI plus bevacizumab as first-line treatment of metastatic colorectal cancer: a propensity score-adjusted analysis from two randomized clinical trials. Ann Oncol. 2016 May;27(5):843-9. doi: 10.1093/annonc/mdw052. Epub 2016 Feb 9.
PubMed 26861604
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Trial of Infusional Fluorouracil, Leucovorin, Oxaliplatin and Irinotecan (FOLFOXIRI) Compared With Infusional Fluorouracil, Leucovorin and Irinotecan (FOLFIRI) as First-line Treatment for Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT01219920
- Acronym / sponsor ID
- ASL601LIOM03
- Conditions
- Metastatic Colorectal Cancer
- Keywords
- Metastatic colorectal cancer, Phase III, FOLFOXIRI, FOLFIRI
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 244 participants (actual)
- Lead sponsor
- Gruppo Oncologico del Nord-OvestUniversity, hospital or other
- Study start
- Nov 2001
- Primary completion
- Nov 2005 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 13 Oct 2010 (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 response rate to conventional chemotherapy with the FOLFIRI regimen as first-line treatment of metastatic colorectal cancer patients.
Detailed description
Survival of patients with metastatic colorectal cancer is correlated with the proportion of patients who receive all the three active drugs in the course of the disease, but not with the proportion of patients who receive any second-line therapy. In a sequential strategy, not all patients who progress after first-line chemotherapy are able to receive second-line treatment. Moreover, there is a correlation between the response rate to chemotherapy and the postchemotherapy radical resection rate of metastases.
Therefore, a way to improve the outcome of metastatic colorectal cancer patients could be to administer a 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 |
|---|---|---|
| FOLFIRI | Active comparator | Drug: FOLFIRIIrinotecan 180 mg/sqm on day 1 Leucovorin 100 mg/sqm on day 1 and day 2 5-fluorouracil 400 mg/sqm bolus followed by 5-fluorouracil 600 mg/sqm 22-hour continuous infusion on day 1 and day 2 Repeated every 2 weeks |
| FOLFOXIRI | Experimental | Drug: FOLFOXIRIIrinotecan 165 mg/sqm on day 1 Oxaliplatin 85 mg/sqm on day 1 Leucovorin 200 mg/sqm on day 1 5-fluorouracil 3200 mg/sqm 48-hour continuous infusion starting on day 1 Repeated every 2 weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- adenocarcinoma of the colon or rectum
- unresectable metastatic disease
- age 18 to 75 years
- Eastern Cooperative Oncology Group (ECOG) performance status of 2 or lower if age 70 years or younger or ECOG performance status of 0 if age 71 to 75 years measurable disease according to WHOcriteria
- leukocyte count of at least 3,500/mm3, neutrophils count of at least 1,500/mm3, platelet count of at least 100,000/mm3
Key exclusion criteria (6 listed)
- previous palliative chemotherapy for metastatic disease
- previous chemotherapy including irinotecan or oxaliplatin
- symptomatic cardiac disease, myocardial infarction in the last 24 months or uncontrolled arrhythmia
- active infections
- inflammatory bowel disease
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 |
|---|---|---|
| FOLFIRIAlso: Campto, l-lederfolin, 5-FUIrinotecan 180 mg/sqm on day 1 Leucovorin 100 mg/sqm on day 1 and day 2 5-fluorouracil 400 mg/sqm bolus followed by 5-fluorouracil 600 mg/sqm 22-hour continuous infusion on day 1 and day 2 Repeated every 2 weeks | Drug | FOLFIRI |
| FOLFOXIRIAlso: Campto, Eloxatin, l-leucovorin, 5FUIrinotecan 165 mg/sqm on day 1 Oxaliplatin 85 mg/sqm on day 1 Leucovorin 200 mg/sqm on day 1 5-fluorouracil 3200 mg/sqm 48-hour continuous infusion starting on day 1 Repeated every 2 weeks | Drug | FOLFOXIRI |
Primary outcome
Response rate (RR)
Time frame: Responses are evaluated every 8 weeks according to WHO criteria and reviewed by an independent panel at the end of treatment (6 months)
Responses are evaluated every 8 weeks according to WHO criteria. The determination of responses and progression was initially based on investigator-reported measurements; computed tomography scans of all responding patients and of patients with stable disease were subsequently subjected to external review by an independent panel.
5 secondary outcomes
Progression-free survival (PFS)
Time frame: Progressions are evaluated every 8 weeks according to WHO criteria and reviewed by an independent panel at the end of follow up (36 months)
Overall survival (OS)
Time frame: For survival analysis participants are followed until death
Postchemotherapy radical (R0) surgical resection rate of metastases
Time frame: Postchemotherapy radical (R0) surgical resection rate of metastases were evaluated every 8 weeks during treatment and during follow up (36 months)
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: Number of Participants with Adverse Events as a Measure of Safety and Tolerability were evaluated every 2 weeks during treatment and every 8 weeks during follow up (36 months)
Quality of life (QoL)
Time frame: Quality of life was evaluated every 2 weeks during treatment and every 8 weeks during follow up (36 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 11 Mar 2015.
- Background: PubMed 17470860Falcone A, Ricci S, Brunetti I, Pfanner E, Allegrini G, Barbara C, Crino L, Benedetti G, Evangelista W, Fanchini L, Cortesi E, Picone V, Vitello S, Chiara S, Granetto C, Porcile G, Fioretto L, Orlandini C, Andreuccetti M, Masi G; Gruppo Oncologico Nord Ovest. Phase III trial of infusional fluorouracil, leucovorin, oxaliplatin, and irinotecan (FOLFOXIRI) compared with infusional fluorouracil, leucovorin, and irinotecan (FOLFIRI) as first-line treatment for metastatic colorectal cancer: the Gruppo Oncologico Nord Ovest. J Clin Oncol. 2007 May 1;25(13):1670-6. doi: 10.1200/JCO.2006.09.0928.
- Background: PubMed 18279572Masi G, Vasile E, Loupakis F, Bursi S, Ricci S, Petrini I, Fontana A, Allegrini G, Falcone A. Triplet combination of fluoropyrimidines, oxaliplatin, and irinotecan in the first-line treatment of metastatic colorectal cancer. Clin Colorectal Cancer. 2008 Jan;7(1):7-14. doi: 10.3816/CCC.2008.n.002.
- Background: PubMed 19247029Masi G, Loupakis F, Pollina L, Vasile E, Cupini S, Ricci S, Brunetti IM, Ferraldeschi R, Naso G, Filipponi F, Pietrabissa A, Goletti O, Baldi G, Fornaro L, Andreuccetti M, Falcone A. Long-term outcome of initially unresectable metastatic colorectal cancer patients treated with 5-fluorouracil/leucovorin, oxaliplatin, and irinotecan (FOLFOXIRI) followed by radical surgery of metastases. Ann Surg. 2009 Mar;249(3):420-5. doi: 10.1097/SLA.0b013e31819a0486.
- Derived from this study: PubMed 26861604Cremolini C, Loupakis F, Masi G, Lonardi S, Granetto C, Mancini ML, Chiara S, Moretto R, Rossini D, Vitello S, Allegrini G, Tonini G, Bergamo F, Tomasello G, Ronzoni M, Buonadonna A, Bustreo S, Barbara C, Boni L, Falcone A. FOLFOXIRI or FOLFOXIRI plus bevacizumab as first-line treatment of metastatic colorectal cancer: a propensity score-adjusted analysis from two randomized clinical trials. Ann Oncol. 2016 May;27(5):843-9. doi: 10.1093/annonc/mdw052. Epub 2016 Feb 9.
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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.
Alfredo Falcone, MD principal investigator
University of Pisa
48 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing FOLFIRI and FOLFOXIRI in people with Metastatic Colorectal Cancer, run by Gruppo Oncologico del Nord-Ovest at 48 sites in Italy.
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 8 inclusion and 6 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 11 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 48 sites in Italy. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Response rate (RR) (time frame: Responses are evaluated every 8 weeks according to WHO criteria and reviewed by an independent panel at the end of treatment (6 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01219920, which also lists 4 linked publications.
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 11 Mar 2015.