Proton Boost for Locally Advanced HEAD AND NECK TUMORS

Neuroendocrine Tumors Clinical Trial

Official title:

Phase II Clinical Study on Proton Therapy Boost (Hadrontherapy) for Locally Advanced HEAD AND NECK TUMORS

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03183271
• Other study ID #: CNAO 06/2011
• Status: Completed
• Phase: N/A
• First received: June 4, 2017
• Last updated: June 13, 2017
• Start date: July 16, 2012
• Est. completion date: September 30, 2016

Study information

• Verified date: June 2017
• Source: CNAO National Center of Oncological Hadrontherapy
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this research project is to test the local response and the acute toxicity (which can be observed within 90 days).

Description:

Local response and acute toxicity are primary endpoints of the trial. At CNAO a proton boost is delivered on the PTV1rx (area at high risk of relapse) up to at least 70 Gy [RBE] in 2-3 Gy [RBE] per fractions for 8-15 total fractions.

PTV2 rx (area at low or intermediate risk of relapse) will be irradiated with photon IMRT up to a total dose of 50-60 Gy [RBE].

Secondary endpoints of the trial are local control, relapse free survival, overall survival, tumor specific survival, intermediate and long term toxicity.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 30, 2016
• Est. primary completion date: March 30, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Histologic/cytologic diagnosis of primary epithelial malignant or neuroendocrine tumour

• Inoperable tumour, locally advanced stage

• Seated in rhinopharynx, nasal and paranasal sinuses, hypopharynx, larynx, oral cavity and oropharynx

• At least one lesion measured according to the RECIST criteria

• Enrollment for irradiation with IMRT up to 50-60 Gy RBE] on the PTV1rx and PTV2 rx to be followed at CNAO with irradiation with proton boost on thePTV1rx.

Exclusion Criteria:

• Metastasis

• Previous radiotherapy

• Any metallic implants or other conditions such to prevent an adequate imaging of target volume

• Unavailability of previous IMRT first phase radiotherapy plans

Related Conditions & MeSH terms

• Carcinoid Tumor
• Carcinoma
• Epithelial Tumor, Malignant
• Head and Neck Neoplasms
• Neoplasms
• Neuroendocrine Tumors

Intervention

Radiation:
• external beam proton radiation therapy.
Treatment of irradiation with protons beam The patients will be enrolled either at the Centro Nazionale di Adroterapia Oncologica (CNAO), Pavia, Italy, or at referral Hospitals enrolling head and neck patients for treatment with photon IMRT.

Locations

Country	Name	City	State
Italy	CNAO	Pavia

Sponsors (1)

Lead Sponsor	Collaborator
CNAO National Center of Oncological Hadrontherapy

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Local response	RECIST criteria	90 days
Primary	Acute toxicity	According to CTCAE v4.0	90 days
Secondary	Local control	RECIST criteria on MRI evaluation	5 years
Secondary	Disease free survival	RECIST criteria on MRI evaluation - months from RT treatment to documented local relapse	5 years
Secondary	Overall survival	On MRI and total body CT evaluation - months from RT treatment to death	5 years
Secondary	Late toxicity	According to CTCAE v4.0 registered during follow up visits	5 years