Multidisciplinary Approach for Poor Prognosis Sinonasal Tumors in Inoperable Patients

Summary

Sinonasal tumors are rare diseases, as they account for the 0.2 % - 0.8 % of all tumors. For patients with inoperable tumors, the prognosis is poor and the current therapy is a combined-modality treatment that is both more effective and associated with less morbidity.

This study proposes innovative integration of multiple modality of treatment modulated by histology, molecular profile and response to induction CT.

Conditions

• Unresectable Sinonasal Tumors

Interventions

DRUG

Cisplatin

80 mg/m2 or 33 mg/m2/day 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)

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 with ENI: HR-PTV: carbon ions 18 - 21 Gy (relative biological effectiveness, 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 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 setting will be prescribed. IR-PTV: 59.4-60 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.

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 · Presidi Ospedalieri Spedali Civili di Brescia

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

• Marco Benazzo, MD · IRCCS Policlinico San Matteo

• Letizia Deantonio, 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

2020-06-30

Completion

2024-01-31

Countries

• Italy

Study Locations