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Dr. Marcello Deraco
U.O. Melanoma e Sarcoma
Istituto Nazionale Tumori Milano
Via Venezian 1
20133 Milano, Italia
www.marcelloderaco.com
info@marcelloderaco.com
Tel/ Fax: +39.02.76008435
MESOTELIOMA

FEASIBILITY OF THE PROJECT

This is a translational and phase II clinical study aiming to determine whether patients affected by peritoneal mesohtelioma (PM) may benefit from a multidisciplinary approach including extensive cytoreductive surgery (CRS) (Peritonectomy), intra peritoneal hyperthermic perfusion (IPHP) and systemic chemotherapy (sCT). We are of the opinion that the present study, which implies the employment of a complex technology as well as a high skilled health team, would be feasible in our institution, because the National Cancer Institute of Milan meets all the requirements and conditions in terms of human, technical and laboratorial facilities. Moreover, the referral characteristic of the institution will guarantee the recruitment of patients according to the sample size calculation, in spite of the rarity of this disease. A web-site is available for neoplastic rare diseases and the NCI maintains many contacts with minor centres by a specialised team co-ordinated by Dr. P. Casali through the use of “Telemedicine”.

The P.I. (Dr. Marcello Deraco) of the present study has a broad theoretical and practical background with locoregional treatments and has been working at the National Cancer Institute of Milan since 1989. He initially acquired the technique of CRS and IPHP working as an associate researcher, at the Department of Surgical Oncology (Director Prof. Ph. Lasser), Unit of Digestive Surgery (Responsible Dr. D. Elias) of the Institute Gustave Roussy Villejuif in France, during 1991-1993. Then, he attended the Department of Surgery of the "Washington Cancer Institute (Director Prof. P. Sugarbaker) at the Washington Hospital Centre, in 1996, as a visiting MD. Prof. Ph. Lasser and Dr. D. Elias introduced the technique of CRS and IPHP in Europe, while, Prof. P. Sugarbaker is the author of peritonectomy procedures which nowadays is increasingly applied in the world. The P.I. is considered one of pioneering surgeon in Italy in the treatment of peritoneal disseminating diseases using the technique of CRS and IPHP. He has already performed 150 surgical procedures of CRS and IPHP that is the largest experience in his country. He is in touch with the important centres in the world treating peritoneal neoplasms and he is considered the expert for Italy in the web site of the "Washington Cancer Institute”. Furthermore, he is Secretary of the S.I.T.I.L.O. (Italian Society of Locoregional Treatment) and the Co-ordinator in the same society of the “Study Group of Neoplastic Peritoneal Diseases”. The P.I. is a Member of: I.S.R.C.T. (International Society for Regional Cancer Therapy); S.I.C.O. (Società Italiana Chirurgia Oncologica); S.I.C. (Società Italiana Chirurgia); from 2001 S.S.O. (Society of Surgical Oncology). Dr. Marcello Deraco participated as Researcher with an effort of 75% to 100% in two recent A.I.R.C. financed studies regarding the subject of the present proposed study. It is due to the A.I.R.C. support that the technique of CRS and IPHP developed at the NCI of Milan and subsequently in other Italian Centres. The first study was proposed in 1995 and allowed the establishment of feasibility of CRS+IPHP at the NCI of Milan. The second study was proposed in 1998 and permitted us to approach rare diseases as Pseudomyxoma Peritonei and PM. NCI of Milan began the referral centre in Italy for the definitive and optimal treatment of these two rare diseases.

Given the multidisciplinary profile of present study, a co-operation with other specialities and disciplines is fundamental for the its feasibility. Accordingly, the project will involve the participation of Unit of Experimental Oncology B and C, as well as unity of Biometry and Radiology; though their support is absolutely fundamental for the project’s execution.

Finally, all required equipments, technological, personnel and laboratorial facilities for this project are available in our Institution.


PROJECT RESPONSIBLE BIOGRAPHICAL SKETCHES

BIOGRAPHICAL SKETCH

Name

Marcello DERACO

Position

Date of Birth 24/08/1962

Date of Doctoral Degree 1987

Doctoral Degree Medical Doctor

Education and Training (include degrees and post-doctoral training)

Institution and Location

Degree

Years

Field of Study

University of Messina

University of Paris

MD

1987

1992

1993

Medical Doctor

General Surgery

Oncology

54 a - RESEARCH AND PROFESSIONAL EXPERIENCE: Concluding with present position, list, in chronological order, previous employment, experience, and honours or patents.

Education

High School                Vincenzo Guerrisi High School Cittanova, RC Italy 1981

Medical Doctor          University of Messina, Italy July 1987

General Surgery         University of Messina, Italy October 1992

Oncology                    University of Paris IX, France 1993

Clinical Experience

Associated Researcher           Dept. of Surgery at the "National Cancer Institute of Milan", Italy

1989-1991/1994-1998

Associated Researcher           Dept. of Surgery at the "Gustave Roussy Institut" Villejuif, France

1991-1993

Associated Researcher           Dept. of Surgery at "The Royal Marsden Hospital" London, UK

1993

Visiting MD                            Dept. of Surgery "Washington Cancer Institute at the Washington Hospital Center", Washington DC USA - 1996

Current Position:                    Attending Surgeon Department of Surgery at the National Cancer Institute of Milan, Italy

Membership and Secretary              SITILO Società Italiana di Terapie Integrate Loco-Regionali in Oncologia (Italian Society for Loco Regional Cancer Therapy)

ISRCT International Society for Regional Cancer Therapy

Membership                                      SIC Società Italiana di Chirurgia

                                                           SICO Società Italiana di Chirurgia Oncologica

SSO Surgical Society Oncology

Licensure                                          European Community

Participation in National Protocols at the National Cancer Institute of Milan

-         "Evaluation of cytoreductive surgery (peritonectomy) and intra peritoneal hyperthermic perfusion in patients affected by pseudomyxoma peritonei or mesothelioma. A phase II clinical study". Study of AIRC 1998-2000.

-         "Intra Peritoneal Hyperthermic Perfusion with Doxorubicin and cisplatin. A multicentric phase I Clinical Study".

-         "Primary Chemotherapy for Locally advanced Gastric Carcinoma".

-         "Treatment of locally advanced gastric cancer by radical surgery and intra peritoneal hyperthermic perfusion. A multicentric phase II clinical study."

-         "Stop-Flow perfusion with Adriamycin + Mitomycin C in the treatment of rectal cancer recurrence. Phase II clinical study."

-         "Intergroups Italian Study, Non resectable pancreatic cancer: Systemic Chemotherapy with 5-FU vs Systemic Chemotherapy with Gemcitabin vs Loco-Regional Chemotherapy with FLEC. A multicentric SITILO randomised clinical study."

-         "A Phase I/II study of active specific immunotherapy in patients with metastatic melanoma using autologous tumour-derived, Heat Shock Protein Peptide Complex-96 (HSPPC-96), vaccine."


CORRELATED PUBLICATIONS

Principal Investigator's Full Name: Marcello DERACO

All Authors Title Journal

(IF list abbreviation)

Volume Number Year Pages

IF (listing 2000)

from

to

Bozzetti F, Vaglini M, Deraco M.

Intraperitoneal hyperthermic chemotherapy in gastric cancer: rationale for a new approach

Tumori

84(4)

1998

83

88

0.485

Rossi CR, Pilati P, Mocellin S, Vaglini M, Deraco M, Lise M.

Ovarian carcinoma: pilot study of hyperthermic intraoperative peritoneal perfusion of antiblastic agents

Tumori

85(3 Suppl 1):

1999

S43

S45

0.485

Deraco M, Santoro N, Carraro O, Inglese MG, Rebuffoni G, Guadagni S, Somers DC, Vaglini M.

Peritoneal carcinomatosis: feature of dissemination. A review

Tumori

85(1)

1999

1

5

0.485

S. Guadagni, A. Pizzuttilli, E. Mancini, A. Varrone, G. Palumbo, G. Amicucci, S. Perri, M. Deraco, G. Fiorentini

Significance of Duplex/color doppler sonography in hepatic arterial-
chemotherapy for patients with liver metastasis from colorectal carcinoma.

Eur. J. Surg. Oncol.

26 (4)

2000

381

386

1.434

S. Kusamura, L.C. Teixeira, M.A. dos Santos, L.A. Andrade, J.C. Campos Torres, A. Sagarra, M. Deraco, S.F.M. Derchain

Ovarian Germ Cell Cancer: clinicopathologic and outcome of 31 cases.

Tumori

86 (6)

2000

450

454

0.485

S. Guadagni, G. Fiorentini, G. Palumbo, M. Valenti, S. Russo, M. Cantore, M. Deraco, M. Vaglini, G. Amicucci

Hypoxic Pelvic Perfusion with Mitomycin C using a simplified balloon-occlusion technique in the treatment of patients with unresectable locally recurrent rectal cancer

Arch Surg

136

2001

105

112

2.629

M. Vaglini, C.R. Rossi, E. Pennacchioli, M. Merson, D. Carlier Somers, N. Santoro, S. Kusamura, M. Deraco

Cytoreductive surgery an intra peritoneal perfusion in the treatment of recurrent epithelial ovarian cancer: a phase II clincial study

Tumori

87

2001

120

126

0.485

S. Guadagni, F. Russo, C.R. Rossi, P.L. Pilati, D. Miotto, G. Fiorentini, M. Deraco, M. Santinami, G. Palumbo, M. Valenti, G. Amicucci

Deliberate hypoxic pelvic and limb chemoperfusion in the treatment of recurrent melanoma

Am J Surg

183 (1)

2001

28

36

2.116

C.R. Rossi, M. Foletto, S. Mocellin, P.L. Pilati, S.M. De, M. Deraco, F. Cavaliere, P. Palatini, F. Guasti, R. Scalerta, M. Lise

Hyperthermic intraoperative intraperitoneal chemotherapy with cisplatin and doxorubicin in patients who undergo cytoreductive surgery for peritoneal carcinomatosis and sarcomatosis: phase I study

Cancer

15 (94)

2002

492

499

3.611

M. Deraco, A. Gronchi, V. Mazzaferro, M.G. Inglese, E. Pennacchioli, S. Kusamura, M. Rizzi, R.A. Jr. Anselmi, M. Vaglini

Feasibility of peritonectomy associated with Intra Peritoneal Hyperthermic Perfusion in patients with Pseudomixoma Peritonei.

Tumori

88

2002

370

375

0.485

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