Colorectal CancerPhase 2NCT01442935

Chemotherapies Associated With Targeted Therapies on the Resection Rate of Hepatic Metastases

A Phase 2 study testing Oxaliplatin, Folinic Acid and 5-FU in people with Colorectal Cancer, run by UNICANCER at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The main objective is to compare resection rates (R0 or R1) for hepatic metastases in the experimental arm (tri chemotherapy plus targeted therapy) versus the control arm (bi chemotherapy plus targeted therapy); in both arms the targeted therapy is selected according to K-Ras status of the patient's tumor. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Colorectal Cancer
What is being tested?: Oxaliplatin, Folinic Acid and 5-FU
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 256 participants
Where: 1 siteFrance
Study dates: Feb 2011to Jan 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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Histologically proven colorectal adenocarcinoma,
Primary tumor of the colon or rectum, resectable or resected at least 3 weeks before randomization or 4 weeks before the beginning of the study treatment,
Metastatic disease with synchronous or metachronous (> 3 months after diagnosis of the primary tumor) hepatic metastasis,
Non-resectable (with respect to curative intent) hepatic metastasis at presentation. This criterion must be validated by both a surgeon and a radiologist during the RCP (Multidisciplinary cancer case presentation committee) patient's evaluation meeting (either technically non-resectable metastases (absolute contraindication): i.e. impossibility to resect all metastases in a single operation while preserving at least 30% of healthy liver tissues and/or impossibility to preserve the portal vein and hepatic artery homolateral to the liver or a portal pedicle, or due to oncological non-resectability (relative contraindication): presence of > 5 nodules and bilateral invasion),
Hepatic metastases, without spread to other sites except in case of ≤ 3 resectable pulmonary metastases of diameter < 2 cm, detected by thoracic scanner,
K-Ras status determined before randomization,

Show all 21Show fewer

Measurable disease according to the RECIST V1.1 criteria,
No prior treatment of the hepatic metastases,
Previous 5FU +/- oxaliplatin-based adjuvant chemotherapy administered after colorectal tumor resection is authorized if complete more than 1 year before,
Age ≥ 18 \& ≤ 75 years
Performance status : ECOG 0 or 1,
Life expectancy ≥ 3 months,
Hemoglobin ≥ 9 g/dl,
Polynuclear neutrophiles ≥ 1500/mm3,
Platelets ≥ 100 000 mm3,
Creatinemia ≤ 135 µmol/l (1,35 mg/dl)
Total bilirubin ≤ 1.25 times the Upper Limit of Normal (ULN).
Hepatic enzymes ASAT and ALAT < 5 x ULN,
Negative pregnancy test for women of child-bearing age,
Information given to the patient and signed informed consent,
Public Health insurance coverage.

Who cannot join

Non metastatic and/or non measurable disease according to the RECIST v1.1 criteria.
Non-resectable primary tumor (e.g.: T4 tumors) or incomplete resection R2.
History of intestinal inflammatory disease.
Specific contraindication to any of the study treatments.
Patient who have previously received anti-EGFr (e.g., cetuximab) or anti-VEGF monoclonal antibody treatment (e.g., bevacizumab) or treatment with irinotecan.
History of cancer considered as not cured.

Show all 14Show fewer

Stroke/CVA or pulmonary embolism within 6 months before inclusion.
Significant concomitant disease such as: coagulopathy, respiratory or cardiac congestive insufficiency, non-medically controlled/unstable angina pectoris, myocardial infarction within 6 months prior to study entry, arterial hypertension and uncontrolled arrhythmia, severe infections.
Clinical neuropathy, grade ≥1.
Patient already included in another therapeutic trial using an experimental molecule.
Pregnant women or women who might become pregnant during the study or lactating women.
Men or women who can procreate and who do not abide with the use of a contraceptive means.
Persons kept in detention or incapable of giving consent
Patient unwilling or unable to comply with the medical follow-up required by the trial because of geographic social or psychological reasons.

Trial locations and contacts

1 site in 1 country.

France1 site

Centre Val d'Aurelle
Montpellier, 34298

Other trials in France

About this study

Official title: Phase II Multicentric Randomized Trial, Evaluating the Best Protocol of Chemotherapy, Associated With Targeted Therapy According to the Tumor KRAS Status, in Metastatic Colorectal Cancer (CCRM) Patients With Initially Non-resectable Hepatic Metastases

The secondary objectives are to evaluate the objective response rate (CR and PR) after 4 cycles of treatment, according the RECIST V1.1 evaluation scale.

the rate of complete remission (CR) at 6 months after the last study treatment (hepatic surgery or last chemotherapy cycle).
the specific rates of resection R0, R1, R2.
the complete pathological response Rate,
the relapse-free survival rate in (R0 or R1) resected patients,
the response duration in non-resected patients,
the toxicity according to CTC AE V4 scale except for the neurotoxicity that will be evaluated with the Levi scale,
the post operative complications using the DINDO classification,
the progression-free survival (PFS) and overall survival (OS).

The objectives of the biological study are:

to evaluate tumor-related predictive factors such as somatic mutations (KRAS, BRAF, TP53) and genetic amplification related factors (EGFR),
to evaluate patient-related predictive factors in connection with genetic polymorphisms (Fc gamma and VEGF receptors),
to evaluate ADCC activity via immunohistochemistry in order to analyze the lympho free and progression-free survival,
to study circulating of tumor cells as prognostic factor for metastatic colorectal cancer, non- resectable at presentation.

Conditions: Colorectal Cancer
Being tested: Oxaliplatin, Folinic Acid, 5-FU, Irinotecan, Bevacizumab
Keywords: Adenocarcinoma, Non-resectable hepatic metastases, First-line treatment
Medical subject headings: Colorectal Neoplasms, Adenocarcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

OxaliplatinDrug
85mg/m² over 120 mn every 2 weeks up to progression or toxicity
Folinic AcidDrug
400mg/m² over 120 mn every 2 weeks up to progression or toxicity
5-FUDrug
Also called 5-Fluoro uracil
400mg/m² in bolus, then 2400mg/m² over 46 h every 2 weeks up to progression or toxicity
IrinotecanDrug
180mg/m² over 90 mn every 2 weeks up to progression or toxicity
IrinotecanDrug
150mg/m² over 30-90 mn every 2 weeks up to progression or toxicity
BevacizumabDrug
5mg/kg over 90 mn every 2 weeks up to progression or toxicity
CetuximabDrug
500mg/m² over 90 mn every 2 weeks up to progression or toxicity

Study groups in NCT01442935
Study group	Role	What they receive
Arm A1 : Folfiri + targeted therapy	Active comparator	Every 2 weeks : * irinotecan 180 mg/m² D1 * Folinic acid 400 mg/m² D1 * 5FU 400 mg/m² bolus * 5FU 2400 mg/m² infusion over 46 h, D1 And targeted therapy in function of Kras: * For mutated Kras = bevacizumab: 5 mg/kg IV on D1 of each cycle of chemotherapy, every 14 days * For non-mutated Kras = cetuximab : 500 mg/m² IV, on D1 of each cycle of chemotherapy, every 14 days. Receives: Drug: Folinic Acid; Drug: 5-FU; Drug: Irinotecan; Drug: Bevacizumab; Drug: Cetuximab
Arm A2 : Folfox 4 + targeted therapy	Active comparator	Every 2 weeks : * oxaliplatin 85 mg/m² D1 * Folinic acid 400 mg/m² D1 * 5FU 400 mg/m² bolus * 5FU 2400 mg/m² infusion over 46 h, D1 And targeted therapy in function of Kras: * For mutated Kras = bevacizumab: 5 mg/kg IV on D1 of each cycle of chemotherapy, every 14 days * For non-mutated Kras = cetuximab : 500 mg/m² IV, on D1 of each cycle of chemotherapy, every 14 days. Receives: Drug: Oxaliplatin; Drug: Folinic Acid; Drug: 5-FU; Drug: Bevacizumab; Drug: Cetuximab
Arm B : Folfirinox + targeted therapy	Experimental	Every 2 weeks : * oxaliplatin 85 mg/m² D1 * irinotecan 150 mg/m² D1 * Folinic acid 400 mg/m² D1 * 5FU 400 mg/m² bolus * 5FU 2400 mg/m² infusion over 46 h, D1. From D7 to D12, prophylactic G-CSF such as Granocyte® will be administered. And targeted therapy in function of Kras: * For mutated Kras = bevacizumab: 5 mg/kg IV on D1 of each cycle of chemotherapy, every 14 days * For non-mutated Kras = cetuximab : 500 mg/m² IV, on D1 of each cycle of chemotherapy, every 14 days. Receives: Drug: Oxaliplatin; Drug: Folinic Acid; Drug: 5-FU; Drug: Irinotecan; Drug: Bevacizumab; Drug: Cetuximab

What is being measured

The primary outcome is the main question the study is designed to answer.

The main objective is to compare resection rates (R0 or R1) for hepatic metastases
Number of patients (%) with hepatic metastases R0 or R1 resection.
Measured: at least 4-6 weeks after the end of chemotherapy

Secondary outcomes (8)

The objective response rate (CR and PR) after 4 cycles of treatment
The objective response rate (CR and PR) will be evaluated by the investigator with RECIST v1.1 criteria after 4 cycles. Patients with symptoms suggestive of disease progression will have a tumoral evaluation when symptoms will occur
Measured: after 8 weeks
Complete remission rate (CR) 6 months after the last study treatment (hepatic surgery or last chemotherapy cycle)
Number of patients (%) with complete remission (CR) at 6 months after the last study treatment (hepatic surgery or last chemotherapy cycle)
Measured: 6 months
Specific resection rates R0/R1/R2
Specific resection rates (%) R0/R1/R2 is the rate of patients with a R0, R1 or R2 resection.
Measured: 24 weeks
Complete pathological response
Number of patients with Complete pathological response, defined as the absence of tumoral residues after the last chemotherapy cycle. It will be evaluated on liver resection piece, based on total or complete tumor necrosis in all tumor nodules
Measured: 24 weeks
Toxicity of treatment
Tolerance of the treatment will be based on toxicities of evaluated products by clinical and biological measurements (NCIC/CTC (CTCAE V4) criteria, except for peripheral neuropathy toxicity (Lévi scale)
Measured: Every 2 weeks
Post operatory complications
Each post operatory complications (Hemorrhage, fistula, insufficiency, heart failure,..) will be graduated using Dindo classification (2004)
Measured: after 4 weeks
Progression-free survival (PFS)
Progression-free survival is defined as the time from randomization to progression (RECIST v1.1 criteria) or death. Patients alive without progression will be censored at the last follow-up.
Measured: 8 months
Overall survival (OS)
Overall survival is defined as the time from randomization to death any cause or last follow-up news for patients alive (censored data).
Measured: 14 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2011Jan 2021

First posted29 Sep 2011 (estimated)
Study startFeb 2011
Primary completionDec 2015
Study completionJan 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Colorectal CancerStudies of the same condition, open and under way.
More trials run by UNICANCERThe 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: 256 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01442935
Sponsor's protocol ID: PRODIGE 14 / ACCORD 21/0905
Other IDs: 2009-012813-22, 2009
Status last verified: Jun 2021
First submitted: 10 Aug 2011
Last updated: 18 Jun 2021
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Publications

Bidard FC, Kiavue N, Ychou M, Cabel L, Stern MH, Madic J, Saliou A, Rampanou A, Decraene C, Bouche O, Rivoire M, Ghiringhelli F, Francois E, Guimbaud R, Mineur L, Khemissa-Akouz F, Mazard T, Moussata D, Proudhon C, Pierga JY, Stanbury T, Thezenas S, Mariani P. Circulating Tumor Cells and Circulating Tumor DNA Detection in Potentially Resectable Metastatic Colorectal Cancer: A Prospective Ancillary Study to the Unicancer Prodige-14 Trial. Cells. 2019 May 28;8(6):516. doi: 10.3390/cells8060516.
PubMed 31142037

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 18 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase II Multicentric Randomized Trial, Evaluating the Best Protocol of Chemotherapy, Associated With Targeted Therapy According to the Tumor KRAS Status, in Metastatic Colorectal Cancer (CCRM) Patients With Initially Non-resectable Hepatic Metastases
ClinicalTrials.gov ID: NCT01442935
Acronym / sponsor ID: PRODIGE 14 / ACCORD 21/0905
Conditions: Colorectal Cancer
Keywords: Adenocarcinoma, Non-resectable hepatic metastases, First-line treatment
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 256 participants (actual)
Lead sponsor: UNICANCERUniversity, hospital or other
Study start: Feb 2011 (actual)
Primary completion: Dec 2015 (actual)
Study completion: Jan 2021 (actual)
First posted: 29 Sep 2011 (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 secondary objectives are to evaluate the objective response rate (CR and PR) after 4 cycles of treatment, according the RECIST V1.1 evaluation scale.

the rate of complete remission (CR) at 6 months after the last study treatment (hepatic surgery or last chemotherapy cycle).
the specific rates of resection R0, R1, R2.
the complete pathological response Rate,
the relapse-free survival rate in (R0 or R1) resected patients,
the response duration in non-resected patients,
the toxicity according to CTC AE V4 scale except for the neurotoxicity that will be evaluated with the Levi scale,
the post operative complications using the DINDO classification,
the progression-free survival (PFS) and overall survival (OS).

The objectives of the biological study are:

to evaluate tumor-related predictive factors such as somatic mutations (KRAS, BRAF, TP53) and genetic amplification related factors (EGFR),
to evaluate patient-related predictive factors in connection with genetic polymorphisms (Fc gamma and VEGF receptors),
to evaluate ADCC activity via immunohistochemistry in order to analyze the lympho free and progression-free survival,
to study circulating of tumor cells as prognostic factor for metastatic colorectal cancer, non- resectable at presentation.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Arm A1 : Folfiri + targeted therapy	Active comparator	Drug: Folinic Acid, Drug: 5-FU, Drug: Irinotecan, Drug: Bevacizumab, Drug: CetuximabEvery 2 weeks : * irinotecan 180 mg/m² D1 * Folinic acid 400 mg/m² D1 * 5FU 400 mg/m² bolus * 5FU 2400 mg/m² infusion over 46 h, D1 And targeted therapy in function of Kras: * For mutated Kras = bevacizumab: 5 mg/kg IV on D1 of each cycle of chemotherapy, every 14 days * For non-mutated Kras = cetuximab : 500 mg/m² IV, on D1 of each cycle of chemotherapy, every 14 days.
Arm A2 : Folfox 4 + targeted therapy	Active comparator	Drug: Oxaliplatin, Drug: Folinic Acid, Drug: 5-FU, Drug: Bevacizumab, Drug: CetuximabEvery 2 weeks : * oxaliplatin 85 mg/m² D1 * Folinic acid 400 mg/m² D1 * 5FU 400 mg/m² bolus * 5FU 2400 mg/m² infusion over 46 h, D1 And targeted therapy in function of Kras: * For mutated Kras = bevacizumab: 5 mg/kg IV on D1 of each cycle of chemotherapy, every 14 days * For non-mutated Kras = cetuximab : 500 mg/m² IV, on D1 of each cycle of chemotherapy, every 14 days.
Arm B : Folfirinox + targeted therapy	Experimental	Drug: Oxaliplatin, Drug: Folinic Acid, Drug: 5-FU, Drug: Irinotecan, Drug: Bevacizumab, Drug: CetuximabEvery 2 weeks : * oxaliplatin 85 mg/m² D1 * irinotecan 150 mg/m² D1 * Folinic acid 400 mg/m² D1 * 5FU 400 mg/m² bolus * 5FU 2400 mg/m² infusion over 46 h, D1. From D7 to D12, prophylactic G-CSF such as Granocyte® will be administered. And targeted therapy in function of Kras: * For mutated Kras = bevacizumab: 5 mg/kg IV on D1 of each cycle of chemotherapy, every 14 days * For non-mutated Kras = cetuximab : 500 mg/m² IV, on D1 of each cycle of chemotherapy, every 14 days.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (21 listed)

Histologically proven colorectal adenocarcinoma,
Primary tumor of the colon or rectum, resectable or resected at least 3 weeks before randomization or 4 weeks before the beginning of the study treatment,
Metastatic disease with synchronous or metachronous (> 3 months after diagnosis of the primary tumor) hepatic metastasis,
Non-resectable (with respect to curative intent) hepatic metastasis at presentation. This criterion must be validated by both a surgeon and a radiologist during the RCP (Multidisciplinary cancer case presentation committee) patient's evaluation meeting (either technically non-resectable metastases (absolute contraindication): i.e. impossibility to resect all metastases in a single operation while preserving at least 30% of healthy liver tissues and/or impossibility to preserve the portal vein and hepatic artery homolateral to the liver or a portal pedicle, or due to oncological non-resectability (relative contraindication): presence of > 5 nodules and bilateral invasion),
Hepatic metastases, without spread to other sites except in case of ≤ 3 resectable pulmonary metastases of diameter < 2 cm, detected by thoracic scanner,

Key exclusion criteria (14 listed)

Non metastatic and/or non measurable disease according to the RECIST v1.1 criteria.
Non-resectable primary tumor (e.g.: T4 tumors) or incomplete resection R2.
History of intestinal inflammatory disease.
Specific contraindication to any of the study treatments.
Patient who have previously received anti-EGFr (e.g., cetuximab) or anti-VEGF monoclonal antibody treatment (e.g., bevacizumab) or treatment with irinotecan.

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
Oxaliplatin85mg/m² over 120 mn every 2 weeks up to progression or toxicity	Drug	Arm A2 : Folfox 4 + targeted therapy, Arm B : Folfirinox + targeted therapy
Folinic Acid400mg/m² over 120 mn every 2 weeks up to progression or toxicity	Drug	Arm A1 : Folfiri + targeted therapy, Arm A2 : Folfox 4 + targeted therapy, Arm B : Folfirinox + targeted therapy
5-FUAlso: 5-Fluoro uracil400mg/m² in bolus, then 2400mg/m² over 46 h every 2 weeks up to progression or toxicity	Drug	Arm A1 : Folfiri + targeted therapy, Arm A2 : Folfox 4 + targeted therapy, Arm B : Folfirinox + targeted therapy
Irinotecan180mg/m² over 90 mn every 2 weeks up to progression or toxicity	Drug	Arm A1 : Folfiri + targeted therapy
Irinotecan150mg/m² over 30-90 mn every 2 weeks up to progression or toxicity	Drug	Arm B : Folfirinox + targeted therapy
Bevacizumab5mg/kg over 90 mn every 2 weeks up to progression or toxicity	Drug	Arm A1 : Folfiri + targeted therapy, Arm A2 : Folfox 4 + targeted therapy, Arm B : Folfirinox + targeted therapy
Cetuximab500mg/m² over 90 mn every 2 weeks up to progression or toxicity	Drug	Arm A1 : Folfiri + targeted therapy, Arm A2 : Folfox 4 + targeted therapy, Arm B : Folfirinox + targeted therapy

Primary outcome

The main objective is to compare resection rates (R0 or R1) for hepatic metastases
Time frame: at least 4-6 weeks after the end of chemotherapy
Number of patients (%) with hepatic metastases R0 or R1 resection.

8 secondary outcomes

The objective response rate (CR and PR) after 4 cycles of treatment
Time frame: after 8 weeks
Complete remission rate (CR) 6 months after the last study treatment (hepatic surgery or last chemotherapy cycle)
Time frame: 6 months
Specific resection rates R0/R1/R2
Time frame: 24 weeks
Complete pathological response
Time frame: 24 weeks
Toxicity of treatment
Time frame: Every 2 weeks
Post operatory complications
Time frame: after 4 weeks
Progression-free survival (PFS)
Time frame: 8 months
Overall survival (OS)
Time frame: 14 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 18 Jun 2021.
Derived from this study: PubMed 31142037Bidard FC, Kiavue N, Ychou M, Cabel L, Stern MH, Madic J, Saliou A, Rampanou A, Decraene C, Bouche O, Rivoire M, Ghiringhelli F, Francois E, Guimbaud R, Mineur L, Khemissa-Akouz F, Mazard T, Moussata D, Proudhon C, Pierga JY, Stanbury T, Thezenas S, Mariani P. Circulating Tumor Cells and Circulating Tumor DNA Detection in Potentially Resectable Metastatic Colorectal Cancer: A Prospective Ancillary Study to the Unicancer Prodige-14 Trial. Cells. 2019 May 28;8(6):516. doi: 10.3390/cells8060516.

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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.

Marc YCHOU, Pr principal investigator

Centre Val d'Aurelle

Eric FRANCOIS, Dr principal investigator

Centre Antoine Lacassagne, Nice

Laurent MINEUR, Dr principal investigator

Institut Ste Catherine-AVIGNON

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 Oxaliplatin, Folinic Acid and 5-FU in people with Colorectal Cancer, run by UNICANCER at 1 site in France.

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 21 inclusion and 14 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 18 Jun 2021. 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 France. 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?

The main objective is to compare resection rates (R0 or R1) for hepatic metastases (time frame: at least 4-6 weeks after the end of chemotherapy). 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 NCT01442935, which also lists 1 linked publication.

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 18 Jun 2021.