Multidisciplinary Approach for Poor Prognosis Sinonasal Tumors in Operable Patients

Summary

Sinonasal tumors are rare diseases, so no standard treatment for such aggressive tumors has been reported, given rarity, absence of prospective study and heterogeneity of histologies and stages of diseases. This study proposes innovative integration of multiple modality of treatment depending by histology, molecular profile and response to induction CT. Moreover, such strategies allows the use of latest technology with greater biological effectiveness and reduction of toxicities.

Conditions

• Sinonasal Tumors

Interventions

DRUG

Cisplatin

80 mg/m2 or 33 mg/m2 or 100 mg/m2 - Concentrate for solution for infusion.

DRUG

Docetaxel

75 mg/m2 - Concentrate for solution for infusion

DRUG

5-fluorouracil

800 mg/m2/day - Concentrate for solution for infusion

DRUG

Etoposide

150 mg/m2/day - Concentrate for solution for infusion

DRUG

Adriamycin

20 mg/m2/day - Powder for solution for infusion

DRUG

Ifosfamide

3000 mg/m2/day - Powder for solution for infusion

DRUG

Leucovorin

250 mg/m2/day - Powder for solution for infusion

RADIATION

Radiotherapy - Patients needing Elective Nodal Volume (ENI)

1. Particle boost with ENI: HR-PTV: carbon ions 18 - 21 Gy (RBE) in fractions of 3 Gy (RBE) without concomitant chemotherapy IR-PTV: this volume is optional, if used it will receive the first 3 fractions i.e. 9 Gy (RBE) of the boost. 2. Photons boost with ENI: HR-PTV: at least 70 Gy with 2-2.12 Gy per fraction and 66 Gy at 2Gy per fraction in radical and postoperative setting will be prescribed. IR-PTV: 59.4-60 Gy with 1.8 Gy-2 Gy per fraction will be prescribed

RADIATION

Radiotherapy - Patients not needing ENI

1. Treatment with particles IR-PTV: this volume can be larger or equal to HR-PTV according to individual situations. 50.4-54 Gy with 1.8-2 Gy per fraction will be prescribed to IR-PTV with protontherapy with concomitant chemotherapy. HR-PTV: carbon ions 18 - 21 Gy (RBE) in fractions of 3 Gy (RBE) without concomitant chemotherapy. The first 3 fractions may be given to the bigger IR-PTV. 2. Treatment with photons. HR-PTV: at least 70 Gy with 2-2.12 Gy per fraction and 66 Gy at 2Gy per fraction in radical and postoperative setting will be prescribed. IR-PTV: 54-60 Gy with 1.8 Gy-2 Gy per fraction will be prescribed

RADIATION

Radiotherapy - Patients needing curative neck irradiation

LR-PTV: 50.4-54 Gy with 1.8-2 Gy per fraction will be prescribed. This volume will always be treated with photons IMRT. 1. Particle boost: HR-PTV: carbon ions 18 - 21 Gy (RBE) in fractions of 3 Gy (RBE) without concomitant chemotherapy IR-PTV: this volume is optional, if used it will receive the first 3 fractions i.e. 9 Gy (RBE) of the boost. 2. Photons boost. HR-PTV: at least 70 Gy with 2-2.12 Gy per fraction and 66 Gy at 2Gy per fraction in radical and postoperative setting will be prescribed. IR-PTV: 59.4-60 Gy with 1.8 Gy-2 Gy per fraction will be prescribed. Concomitant chemotherapy will be administered only in case of radiotherapy with photon beams exclusively.

Sponsors & Collaborators

• Regione Lombardia

  collaborator OTHER

• Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

  lead OTHER

Principal Investigators

• Lisa Licitra, MD · Fondazione IRCCS ISTITUTO NAZIONALE TUMORI

• Piero Nicolai, MD · Presidio Ospedaliero Spedali Civili di Brescia

• Paolo Calstelnuovo, MD · A.O. Ospedale di Circolo e Fondazione Macchi

• Marco Benazzo, MD · IRCCS Policlinico San Matteo

• Andrea Sponghini, MD · Azienda Ospedaliera "Maggiore della Carità"

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-11-30

Primary Completion

2020-01-31

Completion

2024-01-31

Countries

• Italy

Study Locations