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Intermittent or continuous Panitumumab plus FOLFIRI for first-line treatment of patients with RAS and BRAF wild-type metastatic colorectal cancer: a randomized phase 2 trial - IMPROVE

Studio Clinico

Patologia: Tumori del colon retto

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: 

Fase di studio: II

Richiesta mandatoria di tessuto: No

Linee di trattamento: Prima linea

Criteri di inclusione: 

1) Written informed consent to study procedures and to molecular analyses;
2) Histologically proven diagnosis of colorectal cancer with wildtype RAS and BRAF status in certified laboratories;
3) Initially unresectable metastatic colorectal cancer not previously treated with chemotherapy for metastatic disease;
4) At least one measurable lesion according to RECIST1.1 criteria;
5) Availability of a tumor sample (primary and/or metastatic sites) for exploratory research;
6) Age ≥ 18 years;
7) ECOG PS ≤ 2;
8) Life expectancy of at least 12 weeks;
9) Previous adjuvant chemotherapy allowed only if more than 6 months elapsed between the end of adjuvant and first relapse;
10) Neutrophils ≥ 1.5 x 109/L, Platelets ≥100 x 109/L, Hgb ≥ 9 g/dl;
11) Total bilirubin ≤1.5 time the upper-normal limits (UNL) of the normal values and ASAT (SGOT) and/or ALAT (SGPT) ≤ 2.5 x
UNL (or < 5 x UNL in case of liver metastases) alkaline phosphatase ≤ 2.5 x UNL (or < 5 x UNL in case of liver metastases);
12) Creatinine clearance ≥50 mL/min or serum creatinine ≤ 1.5 x UNL;
13) Female with a childbearing potential and male subjects must be willing to use adequate contraception (barrier contraceptive measure, oral contraception, intrauterine device);
14) Will and ability to comply with the protocol.

Criteri di esclusione: 

1) Previous treatment for metastatic disease;
2) Radiotherapy to any site within 4 weeks before the study;
3) Any contraindication to use Panitumumab, Irinotecan, 5-FU or folinic acid
4) Known or clinically suspected brain metastases.
5) History or evidence upon physical examination of CNS disease unless adequately treated.
6) Ascites, pleural effusion or pericardial fluid requiring drainage in last 4 weeks.
7) Diagnosis of interstitial pneumonitis or pulmonary fibrosis;
8) Active uncontrolled infections or other clinically relevant concomitant illness contraindicating chemotherapy administration
or which, in the investigating physician's opinion, rules out the patient's participation in the study;
9) Clinically significant (i.e. active) cardiovascular disease for example cerebrovascular accidents (≤6 months), myocardial
infarction (≤6 months), unstable angina, New York Heart Association (NYHA) grade II or greater congestive heart failure (CHF), serious cardiac arrhythmia requiring medication;
10) Treatment with any investigational drug within 30 days prior to enrolment;
11) Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of localized basal and
squamous cell carcinoma or cervical cancer in situ;
12) Lack of physical integrity of the gastrointestinal tract or history of acute or sub-acute intestinal occlusion or chronic inflammatory bowel disease or chronic diarrhea.
13) Disease that is deemed potentially resectable.
14) Known hypersensitivity to trial drugs or hypersensitivity to any other component of the trial drugs.
15) Any concomitant drugs contraindicated for use with the trial drugs according to the product information of the pharmaceutical companies.
16) Breastfeeding
17) Sexually active males and females (of childbearing potential) unwilling to practice contraception (barrier contraceptive measure or oral contraception) during the study and until 6 months after the last trial treatment.

Trattamento sperimentale: 

Experimental intermittent treatment of Panitumumab + FOLFIRI

Trattamento di controllo: 

Standard continuous treatment of Panitumumab + FOLFIRI

Obiettivi primari dello studio: 

To investigate whether experimental intermittent treatment of Panitumumab + FOLFIRI (given until progression during treatment or cumulative toxicity) results in a Progression Free Survival on treatment (PFSot) similar to that obtained with standard continuous treatment of Panitumumab + FOLFIRI (given until progression or cumulative toxicity).
PFSot is defined as the time from randomization to the first objective disease progression documented in patients undergoing
treatment cycle (objective disease progression during treatment free intervals are excluded) or death due to any cause, whichever occurs first.

Obiettivi secondari dello studio: 

• Safety and tolerability
• Quality of life (QoL)
• Overall response rate (ORR)
• Duration of response (DoR)
• Early Tumor Shrinkage (ETS)
• Deepness of response (DpR)
• Overall Survival (OS)

Centri partecipanti

Nord Italia

IRCCS A.O.U. San Martino - IST
Largo Rosanna Benzi 10 - 16132 Genova - GE

Riferimento: Prof. Alberto Sobrero
Telefono: 0105554381
Email: alberto.sobrero@hsanmartino.it

 

A.O.U. Policlinico di Modena
Via del Pozzo 71 - 41100 Modena - MO

Riferimento: Dr. Luppi
Telefono: 0594225646
Email: comsegreteria@policlinico.mo.it

 

AO - Ordine Mauriziano
Largo Turati 62 - 10128 Torino - TO

Riferimento: Prof. Massimo Di Maio
Telefono: 0115082032
Email: massimo.dimaio@unito.it

 

Ospedale di Vicenza
Viale Rodolfi 37 - 36100 Vicenza - VI

Riferimento: Dr. Giuseppe Aprile
Telefono: 0444753259
Email: giuseppe.aprile@aulss8.veneto.it

 

Centro Italia

Istituto Nazionale Tumori “Regina Elena”
Via Elio Chianesi 53 - 00144 Roma - RM

Riferimento: Dr. Massimo Zeuli
Email: zeuli@ifo.it

 

Università Campus Bio-medico
Via Álvaro del Portillo 200 - 00128 Roma - RM

Riferimento: Prof. Daniele Santini
Telefono: 06225411227
Email: d.santini@unicampus.it

 

Sud Italia e isole

A.O.S.G. Moscati
Contrada Amoretta - 83100 Avellino - AV

Riferimento: Dr. Cesare Gridelli
Telefono: 0825203573
Email: oncologia-avellino@libero.it

 

A.O. Universitaria Consorziale Policlinico di Bari
Piazza G. Cesare 11 - 70100 Bari - BA

Riferimento: Prof. Francesco Silvestris
Telefono: 0805594062
Email: francesco.silvestris@uniba.it

 

Istituto Tumori “Giovanni Paolo II” IRCCS
Viale Orazio Flacco 65 - 70124 Bari - BA

Riferimento: Dr. Francesco Giuliani

 

IRCCS - 'Saverio de Bellis'
Via Turi 27 - 70013 Castellana Grotte - BA

Riferimento: Dr. Ivan Lolli

 

Ospedale Sacro cuore di Gesù - Fatebenefratelli
Viale Principe di Napoli 14/A - 82100 Benevento - BN

Riferimento: Dr. Antonio Febbraro
Telefono: 0824771271
Email: febbraro.antonio@fbfbn.it

 

AOU di Cagliari - Presidio Policlinico Monserrato
St.Statale 554, Km 4500 - 09100 Monserrato - CA

Riferimento: Prof. Mario Scartozzi
Telefono: 07051093217
Email: marioscartozzi@gmail.com

 

Fondazione Giovanni Paolo II - Campobasso
Largo Agostino Gemelli 1 - 86100 Campobasso - CB

Riferimento: Dr. Carmelo Pozzo

 

Presidio Ospedaliero Mariano Santo
Contrada Muoio Piccolo - 87100 Cosenza - CS

Riferimento: Dr. Serafino Conforti

 

Presidio Ospedaliero Vito Fazzi Asl Lecce
Piazzetta F. Muratore - 73100 Lecce - LE

Riferimento: Dr.ssa Silvana Leo
Telefono: 0832661692

 

Azienda Ospedaliera Vincenzo Monaldi
Via Leonardo Bianchi 1 - 80131 Napoli - NA

Riferimento: Dr. Vincenzo Montesarchio

 

Istituto Nazionale Tumori IRCCS Fondazione Pascale
Via Mariano Semmola - 80131 Napoli - NA

Riferimento: Dr. Antonio Avallone
Telefono: 0815903360
Email: a.avallone@istitutotumori.na.it

 

A.O. S.Carlo
Via P. Petrone 1 - 85100 Potenza - PZ

Riferimento: Dr. Domenico Bilancia
Email: domenico.bilancia@ospedalesancarlo.it

Informazioni Generali

Protocollo

Numero di iscrizione a registro: 2017-003628-65

Data di inserimento: 24.04.2018

Promotore

Istituto Nazionale dei Tumori, Fondazione “G. Pascale”

CRO

NA

Principal Investigator ITALIA

Istituto Nazionale dei Tumori, Fondazione “G. Pascale”

Riferimento: Dr. Antonio Avallone

Telefono: 0815903360

Email: a.avallone@istitutotumori.na.it

Localita: Napoli

 

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