NCT03196700

Brief Summary

The study wants to define the maximum tolerated dose (MTD), safety and efficacy of a short course radiation treatment in patients with symptomatic advanced head and neck cancer.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2009

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

June 20, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 23, 2017

Completed
Last Updated

June 23, 2017

Status Verified

June 1, 2017

Enrollment Period

8 years

First QC Date

June 20, 2017

Last Update Submit

June 21, 2017

Conditions

Palliative Care

Keywords

palliative carehead and neck cancerradiotherapypainquality of life

Outcome Measures

Primary Outcomes (1)

  • Maximum tolerated dose

    The maximum tolerated dose is defined as the dose level below the highest administered dose associated with dose limiting toxicity (DLT) in at least one third of patients

    1 year

Secondary Outcomes (4)

  • Acute toxicity

    1 year

  • Quality of life

    1 year

  • Pain relief

    1 year

  • Late toxicity

    1 year

Study Arms (1)

Short course radiotherapy

EXPERIMENTAL

The radiotherapy is delivered over two days with accelerated hypo-fractionation was delivered

Radiation: Short course radiotherapy

Interventions

Short course radiotherapyRADIATION

An accelerated hypo-fractionation radiotherapy is delivered for palliation in patients with metastatic or locally advanced head and neck cancer.

Short course radiotherapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • histologically proven locally advanced or metastatic H\&N cancer
  • excluded from curative therapy because of disease stage and/or presence of multiple comorbidities and/or poor performance status
  • age \> 18 years
  • Eastern Cooperative Oncology Group (ECOG) performance status \< 3

You may not qualify if:

  • prior RT to the same region.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Head and Neck NeoplasmsPain

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Alessio G. Morganti, MD

    Radiation Oncology Center, Department of Experimental, Diagnostic and Specialty Medicine - DIMES, University of Bologna, S. Orsola-Malpighi Hospital, Bologna, Italy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 20, 2017

First Posted

June 23, 2017

Study Start

January 1, 2009

Primary Completion

January 1, 2017

Study Completion

June 1, 2017

Last Updated

June 23, 2017

Record last verified: 2017-06