AzTrials
AzTrials

Metastatic Colorectal CancerPhase 3ITACaNCT01878422

Sequential Treatment Strategy for Metastatic Colorectal Cancer

A Phase 3 study testing Arm A: FOLFIRI or FOLFOX + Bevacizumab, Arm B: FOLFIRI or FOLFOX and Arm D: FOLFIRI or FOLFOX plus CETUXIMAB in people with Metastatic Colorectal Cancer, run by Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS at 23 sites in Italy.

Completed

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

Official record
Search all trials

Trial summary

Study Design: This is a pragmatic study on the management strategy for patients with metastatic colorectal cancer (CRC) who are candidates for CT, independently of any previous adjuvant therapy received. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic Colorectal Cancer
What is being tested?
Arm A: FOLFIRI or FOLFOX + Bevacizumab, Arm B: FOLFIRI or FOLFOX and Arm D: FOLFIRI or FOLFOX plus CETUXIMAB
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
376 participants
Where
23 sitesItaly
Study dates
Nov 2007to 11 Jun 2016
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically or cytologically confirmed untreated metastatic or locally advanced, non resectable CRC; previous adjuvant chemotherapy for CRC or neoadjuvant/adjuvant chemoradiotherapy for rectal cancer is permitted but must have been completed at least 6 months prior to enrolment;
  • Resected CRC patients who have developed metastases do not require separate histological or cytological confirmation unless > 5 yrs have elapsed between primary surgery or primary tumor stage I;
  • Evaluation of Kras status from the primary tumor or metastases
  • Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST criteria)
  • Age ≥ 18 years and < 70 years with Performance Status (ECOG) ≤ 2 or age > 70 years with ECOG ≤ 1;
  • Estimated life expectancy of at least 12 weeks;
Show all 10Show fewer
  • Adequate hematological, hepatic and renal function, as follows: hemoglobin ≥ 9 g/dl,absolute neutrophil count ≥1,500/μL, platelets ≥100,000/μL, total bilirubin ≤1.5 x upper limit of normal (ULN),alkaline phosphatase, aspartate aminotransferase (AST(SGOT)) and alanine aminotransferase (ALT(SGPT)) ≤ 2.5 x ULN (≤ 5 x ULN if liver metastases present), serum creatinine ≤ 1.5 x ULN or calculated creatinine clearance >50 mL/min (calculated on the basis of Standard Cockcroft and Gault Formula, urinary excretion (if protein > 30 mg/dL or +1, patients must have ≤ 1 g of protein/24 hours)
  • Either international normalized ratio (INR) or activated partial thromboplastin time (APTT) < 1.5 x ULN and D-dimer within normal range (if abnormal, thromboembolic events must be excluded);
  • Negative pregnancy test no more than 7 days before randomization; test pregnancy can be omitted only in women without any reproductive potential (e.g.: postmenopausal women, i.e. amenorrhoea ≥2 years or with previous hysterectomy or bilateral ovariectomy). Women of child-bearing potential and men must agree to use adequate contraception at the time of randomization and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician and coordinating centre (CC) immediately; women in lactation period must be excluded;
  • Ability to understand and the willingness to sign a written informed consent document.

Who cannot join

  • Prior treatment with cetuximab, bevacizumab or other anti Epidermal Growth Factor Receptor (antiEGFR) or anti-angiogenesis agents;
  • Prior chemotherapy or immunotherapy for metastatic or advanced disease;
  • Participation in another clinical trial with any investigational agents ≤ 30 days prior to study randomization;
  • Contraindications or hypersensitivity to study drugs;
  • Treatment with other concomitant antineoplastic drugs;
  • Other known malignant neoplastic diseases in the patient's medical history with a disease-free interval of less than 5 years (except for previously treated basal cell carcinoma and in situ carcinoma of the uterine cervix);
Show all 29Show fewer
  • Symptomatic brain or central nervous system metastases or clinically relevant central nervous diseases (for example: primary brain tumor, uncontrolled convulsions with medical therapy, carcinomatous meningitis);
  • Grade > 1 peripheral neuropathy (as defined by the National Cancer Institute - Common Toxicity Criteria for Adverse Effects (NCI CTCAE) v3.0);
  • Clinically significant (i.e. active) cardiovascular disease e.g. cerebrovascular accidents ≤ 6 months prior to randomization), myocardial infarction (≤ 1 year prior to randomization), uncontrolled hypertension whilst receiving chronic medication, unstable angina, New York Heart Association (NYHA) grade II or more congestive heart failure,or serious cardiac arrhythmia requiring medication;
  • Malabsorption syndrome or lack of physical integrity of the gastrointestinal tract. Diverticulitis. Patients with colostomy or ileostomy may enter at the investigator's discretion. History of trachea-oesophageal fistula or any other type of fistula (e.g. abdominal), gastrointestinal perforation, intra-abdominal abscess;
  • Interstitial pneumonia or extensive symptomatic fibrosis of the lungs;
  • Serious, non-healing wound, ulcer, or bone fracture; significant traumatic injury in the 4 weeks prior to enrolment (complete recover must have occurred);
  • Major surgery (e.g. laparotomy) in the 4 weeks prior to study randomization;
  • Minor surgery in the 2 weeks prior to study randomization. Insertion of a central vascular access device for chemotherapy infusion must be done at least 2 days prior to the start of treatment. Patients will be randomized only if they have recovered from all surgery related toxicities;
  • Bleeding diathesis or coagulopathy;
  • Pulmonary embolism or any arterial thromboembolism;
  • Deep vein thrombosis or other significant thromboembolic event;
  • Clinically significant peripheral vascular disease;
  • Previous organ transplantation that requires immunosuppressive therapy;
  • Need for chronic oral steroid use ( ≥10 mg/day of methylprednisolone or equivalent) for the treatment of a nonmalignant condition other than intermittent prophylactic use as an antiemetic and inhaled steroid use;
  • Chronic use of aspirin (> 325 mg/day) or other non steroidal anti-inflammatory agents (those known to inhibit platelet function at doses used to treat chronic inflammatory diseases);
  • In treatment with antiplatelets agents (i.e clopidogrel > 75 mg/day, ticlopidine,dipyridamole);
  • Undergoing treatment with sorivudine or its chemically-related analogues (such as brivudine);
  • Full-dose oral or parenteral anticoagulants or thrombolytic treatment for therapeutic purposes ≤10 days prior to study randomization;
  • Geographic inaccessibility;
  • Any radiation therapy completed ≤ 4 weeks prior to study randomization. If the radiated lesion/s is/are the only site of disease, and if it/they show progression after the radiotherapeutic procedure, the patient will become eligible for the study;
  • Previous embolization or thermoablation of metastases ≤ 30 days prior to study randomization. If these lesions are the only site of disease, and if they show progression after the embolization or thermoablation procedure, the patient will become eligible for the study;
  • Laboratory abnormality or medical or psychiatric disorders that would interfere with informed consent or compliance, or which could indicate a contraindication to patient enrolment into the study (also known dihydropyrimidine dehydrogenase deficit);
  • HIV-positivity, whether or not symptomatic.

Trial locations and contacts

23 sites in 1 country.

23 sites in 1 country

Italy23 sites

  • P.O. San lazzaro

    Alba, CN

  • Ospedale Cardinal Massaia

    Asti

  • Azienda ULSS 1 di Belluno

    Belluno

  • Dipartimento Oncologia Ematologia - Policlinico S.Orsola-Malpighi - Università di Bologna

    Bologna, BO

  • Ist. di Ematologia e Oncologia Medica "L. e A. Seragnoli" - Università di Bologna

    Bologna, BO

  • Ospedale Bellaria-Maggiore, AUSL Città di Bologna

    Bologna, BO

  • Ospedale A.Perrino

    Brindisi

  • Ospedale Ramazzini - ASL Modena

    Carpi, MO

  • ospedale Civile Cattolica

    Cattolica, RN

  • Ospedale Buffalini - ASL Cesena

    Cesena, FC

  • Ospedale degli Infermi - AUSL di Ravenna

    Faenza, RA

  • Azienda Ospedaliero - Università di Ferrara

    Ferrara, FE

  • Ospedale Vito Fazzi

    Lecce, LE

  • Ospedale Civile di Lugo -AUSL di Ravenna

    Lugo, RA

  • Irccs Irst

    Meldola (FC), FC, 47014

  • Centro Oncologico Modenese - Policlinico di Modena

    Modena, MO

  • Azienda Osp. Maggiore della Carità

    Novara

  • Azienda Ospedaliero Universitaria di Parma

    Parma

  • Ospedale di Piacenza, ASL Piacenza

    Piacenza

  • Ospedale S.Maria delle Croci

    Ravenna, RA

  • Ospedale Infermi - Azienda USL di Rimini

    Rimini, RN

  • AOU S.Giovanni Battista di Torino (Molinette) Presidio San Lazzaro

    Torino, TO

  • Azienda Sanitaria Ospedaliera S. Giovanni Battista - Molinette

    Torino, TO

Other trials in Italy

About this study

Official title: SEQUENTIAL TREATMENT STRATEGY FOR METASTATIC COLORECTAL CANCER: A PHASE III PROSPECTIVE RANDOMIZED MULTICENTER STUDY OF CHEMOTHERAPY (CT) WITH OR WITHOUT BEVACIZUMAB AS FIRST-LINE THERAPY FOLLOWED BY TWO PHASE III RANDOMIZED STUDIES OF CT ALONE OR CT PLUS BEVACIZUMAB WITH OR WITHOUT CETUXIMAB AS SECOND-LINE THERAPY

Study Design: This is a pragmatic study on the management strategy for patients with metastatic colorectal cancer (CRC) who are candidates for CT, independently of any previous adjuvant therapy received. The aim of this study is to define the role of new target molecules in combination with CT in first- and second line treatment.

First line study: Eligible patients were randomized to either treatment:

Read more

Arm A: FOLFIRI or FOLFOX + Bevacizumab, cycle to be repeated every 2 weeks

  • BEVACIZUMAB: Day 1,1st cycle 5 mg/kg IV infusion of 90 min Day 1, 2nd cycle if well tolerated, 5 mg/kg IV infusion of 60 min Day 1, 3rd cycle and subsequent cycles if well tolerated, 5 mg/kg IV infusion of 30 min after 5-Fluorouracile (FU) bolus
  • FOLFIRI Day 1: Irinotecan 180 mg/m2 IV infusion 30-90 min

Day 1,2:

L-Folinic acid 100 mg/m2 IV infusion of 2 hours 5-Fluorouracil 400 mg/m2 as a bolus 5-Fluorouracil 600 mg/m2 continuous IV infusion of 22 hours - FOLFOX Day 1: Oxaliplatin 85 mg/m2 IV infusion of 2hours

Day 1,2:

L-Folinic acid 100 mg/m2 IV infusion of 2 hours 5-Fluorouracil 400 mg/m2 as a bolus 5-Fluorouracil 600 mg/m2 continuous IV infusion of 22 hours Arm B: FOLFIRI or FOLFOX, cycle to be repeated every 2 weeks If FOLFIRI: FOLFIRI as specified in arm A without Bevacizumab If FOLFOX: FOLFOX as specified in arm A without Bevacizumab Duration of Therapy For both arms, CT was repeated until progressive disease (PD) or unacceptable toxicity occurs. If unacceptable CT-related toxicity occurs in ARM A, in the absence of PD patients stopped CT and continued with only bevacizumab 5 mg/kg as a 30-min infusion every 2 weeks until progression or intolerable toxicity occurred.

Second line - it is divided in two different studies (2A and 2B):

Study 2A: Patients from arm A and Kras Wild Type were randomized to:

  • Arm C: FOLFIRI or FOLFOX (the CT schedule not received in 1st line trial, as defined in arm B)
  • Arm D: FOLFIRI or FOLFOX (the CT schedule not received in 1st line trial, as described in arm B) plus CETUXIMAB CETUXIMAB 1st cycle Day 1 400 mg/m2 infusion of 120 min 2 hrs before CT infusion 1st cycle Day 8 and subsequent cycles 250 mg/m2 infusion of 60 min 1 hr before CT infusion Patients from arm A and Kras Mutant were treated according to arm C.

Study 2B: Patients from arm B and Kras Wild Type were randomized to:

  • Arm E: FOLFIRI or FOLFOX (the CT schedule not received in the 1st line trial, as defined in arm B) plus BEVACIZUMAB
  • Arm F: FOLFIRI or FOLFOX (the CT schedule not received in the first-line trial, as defined in arm B) plus BEVACIZUMAB and CETUXIMAB; cycle to be repeated every 2 weeks, whilst cetuximab will be administered weekly.
  • BEVACIZUMAB 2nd day of 1st cycle 5 mg/kg IV infusion of 90 min 2nd day of 2 nd cycle if well tolerated, 5 mg/kg IV infusion of 60 min 2nd day of 3 rd cycle and subsequent cycles if well tolerated, 5 mg/kg IV infusion of 30 min after the end of 5-FU bolus on the 2nd day
  • CETUXIMAB 1st cycle Day 1 400 mg/m2 infusion of 120 min 2 hr before CT infusion 1st cycle Day 8 and subsequent cycles 250 mg/m2 infusion of 60 min 1 hr before CT infusion If cetuximab will be stopped for any of the reasons specified in this protocol, bevacizumab will be administered as defined in arm A of the 1st line study Patients from arm B and Kras Mutant were treated according to arm E. Objectives of study The primary objective of the 1st line study is to determine whether the addition of bevacizumab to a poly-chemotherapy (polyCT) regimen (FOLFIRI or FOLFOX) improves efficacy in terms of progression-free survival (PFS). The secondary objectives of the 1st line study are to determine the Overall Response Rate (ORR) and the safety profile of the treatments administered.

The primary objective of the 2nd line studies is to determine, separately for each study, whether the addition of cetuximab to a polyCT schemes (FOLFOX or FOLFIRI), or to polyCT schemes plus bevacizumab, improves efficacy in terms of PFS.The secondary objectives of the 2nd line studies are to determine the ORR, the overall survival (OS) and the safety profile of the treatments administered.

Being tested
Arm A: FOLFIRI or FOLFOX + Bevacizumab, Arm B: FOLFIRI or FOLFOX, Arm D: FOLFIRI or FOLFOX plus CETUXIMAB, Arm F: FOLFIRI or FOLFOX plus BEVACIZUMAB and CETUXIMAB
Medical subject headings
Colorectal Neoplasms

What participants receive

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

  • Arm A: FOLFIRI or FOLFOX + BevacizumabDrug

    Also called Arm E: FOLFIRI or FOLFOX plus BEVACIZUMAB

    Arm A: FOLFIRI or FOLFOX + Bevacizumab or Arm E: FOLFIRI or FOLFOX plus BEVACIZUMAB

  • Arm B: FOLFIRI or FOLFOXDrug

    Also called Arm C: FOLFIRI or FOLFOX

    Arm B: FOLFIRI or FOLFOX or Arm C: FOLFIRI or FOLFOX

  • Arm D: FOLFIRI or FOLFOX plus CETUXIMABDrug

    Also called FOLFIRI or FOLFOX plus CETUXIMAB

    Arm D: FOLFIRI or FOLFOX plus CETUXIMAB

  • Arm F: FOLFIRI or FOLFOX plus BEVACIZUMAB and CETUXIMABDrug

    Also called FOLFIRI or FOLFOX plus BEVACIZUMAB and CETUXIMAB

    Arm F: FOLFIRI or FOLFOX plus BEVACIZUMAB and CETUXIMAB

Study groups in NCT01878422
Study groupRoleWhat they receive
Arm A: FOLFIRI or FOLFOX + BevacizumabExperimental* BEVACIZUMAB: Day 1,1st cycle 5 mg/kg IV infusion of 90 min Day 1, 2nd cycle if well tolerated, 5 mg/kg IV infusion of 60 min Day 1, 3rd cycle and subsequent cycles if well tolerated, 5 mg/kg IV infusion of 30 min after 5-FU bolus * FOLFIRI Day 1: Irinotecan 180 mg/m2 IV infusion 30-90 min Day 1,2: L-Folinic acid 100 mg/m2 IV infusion of 2 hours 5-Fluorouracil 400 mg/m2 as a bolus 5-Fluorouracil 600 mg/m2 continuous IV infusion of 22 hours - FOLFOX Day 1: Oxaliplatin 85 mg/m2 IV infusion of 2hours Day 1,2: L-Folinic acid 100 mg/m2 IV infusion of 2 hours 5-Fluorouracil 400 mg/m2 as a bolus 5-Fluorouracil 600 mg/m2 continuous IV infusion of 22 hours
Receives: Drug: Arm A: FOLFIRI or FOLFOX + Bevacizumab
Arm B: FOLFIRI or FOLFOXExperimentalIf FOLFIRI: FOLFIRI as specified in arm A without Bevacizumab If FOLFOX: FOLFOX as specified in arm A without Bevacizumab
Receives: Drug: Arm B: FOLFIRI or FOLFOX
Arm C: FOLFIRI or FOLFOXExperimentalArm C: FOLFIRI or FOLFOX: for patients from arm A: FOLFIRI or FOLFOX (the CT schedule not received in 1st line trial, as defined in arm B)
Receives: Drug: Arm B: FOLFIRI or FOLFOX
Arm D: FOLFIRI or FOLFOX plus CETUXIMABExperimentalArm D: FOLFIRI or FOLFOX plus CETUXIMAB: for patients from arm B: FOLFIRI or FOLFOX (the CT schedule not received in 1st line trial, as described in arm B) plus CETUXIMAB
Receives: Drug: Arm D: FOLFIRI or FOLFOX plus CETUXIMAB
Arm E: FOLFIRI or FOLFOX plus BEVACIZUMABExperimentalfor patients from arm B: FOLFIRI or FOLFOX (the CT schedule not received in the 1st line trial, as defined in arm B) plus BEVACIZUMAB
Receives: Drug: Arm A: FOLFIRI or FOLFOX + Bevacizumab
Arm F: FOLFIRI or FOLFOX plus BEVACIZUMAB and CETUXIMAB;Experimentalfor patients from arm B: FOLFIRI or FOLFOX (the CT schedule not received in the first-line trial, as defined in arm B) plus BEVACIZUMAB and CETUXIMAB; cycle to be repeated every 2 weeks, whilst cetuximab will be administered weekly.
Receives: Drug: Arm F: FOLFIRI or FOLFOX plus BEVACIZUMAB and CETUXIMAB

What is being measured

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

  1. Progression Free Survival (PFS) of first and second line treatment strategy

    To compare the Progression Free Survival (PFS) between different treatment arms in patients of first line treatment and, subsequently, the same analisys will be performed in patients treated in second line therapy.

    Measured: 6 years

Secondary outcomes (3)

  1. Overal Response Rate (ORR) of first and second line treatment strategy

    To compare the Overal Response Rate (ORR) between different treatment arms in patients of first line treatment and, subsequently, the same analisys will be performed in patients treated in second line therapy.

    Measured: 6 years

  2. Overal Survival (OS) of second line treatment

    To compare the Overal Survival (OS) between different treatment arms in patients of second line treatment

    Measured: 6 years

  3. Number of partecipants with adverse events as a measure of safety and tolerability

    To compare the number of partecipants with adverse events as a measure of safety and tolerability between different treatment arms of first line treatment and, subsequently, the same analisys will be performed in patients treated in second line therapy.

    Measured: 6 years

Timeline

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

  1. First posted17 Jun 2013 (estimated)
  2. Study startNov 2007
  3. Primary completionMar 2014
  4. Study completion11 Jun 2016

Resources

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
376 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01878422
Sponsor's protocol ID
IRST153.01
Other IDs
2007-004539-44
Acronym
ITACa
Status last verified
Jan 2025
First submitted
7 Jun 2013
Last updated
31 Jan 2025
Results posted
No
Data monitoring committee
No

Publications

  • Petracci E, Passardi A, Biggeri A, Valgiusti M, Monti M, Frassineti GL, Nanni O, Scarpi E. Baseline and Longitudinal Neutrophil-to-Lymphocyte Ratio as Prognostic Factor for Metastatic Colorectal Cancer: A Secondary Analysis of the ITACa Randomized Trial. JCO Precis Oncol. 2024 Jan;8:e2300256. doi: 10.1200/PO.23.00256.

    PubMed 38295317

  • Casadei Gardini A, Scarpi E, Valgiusti M, Monti M, Ruscelli S, Matteucci L, Bartolini G, Vertogen B, Pagan F, Rovesti G, Frassineti GL, Passardi A. Prognostic role of a new index (multi inflammatory index) in patients with metastatic colorectal cancer: results from the randomized ITACa trial. Ther Adv Med Oncol. 2020 Sep 28;12:1758835920958363. doi: 10.1177/1758835920958363. eCollection 2020.

    PubMed 33062063

  • Casadei-Gardini A, Scarpi E, Ulivi P, Palladino MA, Accettura C, Bernardini I, Spallanzani A, Gelsomino F, Corbelli J, Marisi G, Ruscelli S, Valgiusti M, Frassineti GL, Passardi A. Prognostic role of a new inflammatory index with neutrophil-to-lymphocyte ratio and lactate dehydrogenase (CII: Colon Inflammatory Index) in patients with metastatic colorectal cancer: results from the randomized Italian Trial in Advanced Colorectal Cancer (ITACa) study. Cancer Manag Res. 2019 May 10;11:4357-4369. doi: 10.2147/CMAR.S198651. eCollection 2019.

    PubMed 31191000

  • Passardi A, Scarpi E, Tamberi S, Cavanna L, Tassinari D, Fontana A, Pini S, Bernardini I, Accettura C, Ulivi P, Frassineti GL, Amadori D. Impact of Pre-Treatment Lactate Dehydrogenase Levels on Prognosis and Bevacizumab Efficacy in Patients with Metastatic Colorectal Cancer. PLoS One. 2015 Aug 5;10(8):e0134732. doi: 10.1371/journal.pone.0134732. eCollection 2015.

    PubMed 26244985

  • Passardi A, Nanni O, Tassinari D, Turci D, Cavanna L, Fontana A, Ruscelli S, Mucciarini C, Lorusso V, Ragazzini A, Frassineti GL, Amadori D. Effectiveness of bevacizumab added to standard chemotherapy in metastatic colorectal cancer: final results for first-line treatment from the ITACa randomized clinical trial. Ann Oncol. 2015 Jun;26(6):1201-1207. doi: 10.1093/annonc/mdv130. Epub 2015 Mar 3.

    PubMed 25735317

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Arm A: FOLFIRI or FOLFOX + Bevacizumab, Arm B: FOLFIRI or FOLFOX and Arm D: FOLFIRI or FOLFOX plus CETUXIMAB in people with Metastatic Colorectal Cancer, run by Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS at 23 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 10 inclusion and 29 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 31 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 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?

Progression Free Survival (PFS) of first and second line treatment strategy (time frame: 6 years). 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 NCT01878422, which also lists 5 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 31 Jan 2025.

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