Short Course Radiation Therapy in Palliative Treatment of Head and Neck Cancer
Primary Purpose
Head and Neck Cancer, Radiotherapy, Palliative Care
Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
standard treatment
short course treatment
Sponsored by
About this trial
This is an interventional treatment trial for Head and Neck Cancer focused on measuring Short Course Radiotherapy, Symptomatic head and neck lesions
Eligibility Criteria
Inclusion Criteria:
- symptomatic H&N malignant lesions (primary solid tumors or metastases from solid tumor)
- age>18 years
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-3
- no changes in supportive care in the week before radiotherapy
Exclusion Criteria:
- pregnancy
- previous irradiation of the same region
Sites / Locations
- Radiation Oncology Center, Department of Experimental, Diagnostic and Speciality Medicine- DIMES, University of Bologna, S.Orsola-Malpighi HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
standard treatment
short course treatment
Arm Description
patients in this group are treated with 3000 cGy in 10 daily fraction
patients in this group are treated with 2000 cGy in 4 fractions administered twice a day (at least 6-8 hours interval)
Outcomes
Primary Outcome Measures
Efficacy of palliation using the short course scheme compared with the standard scheme
reduction of initial symptoms (pain, bleeding, dysphagia, hoarseness, stridor, dehydration, malnutrition) after radiotherapy, evaluated as none-mild-moderate-severe before and after treatment
Secondary Outcome Measures
acute toxicity in the two treatment groups
incidence of treatment-related acute adverse events in the two arms of the study registered using Radiation Therapy Oncology Group (RTOG) Cooperative Group Common Toxicity Criteria
late toxicity in the two treatment groups
incidence of treatment-related adverse events in the two arms of the study registered using RTOG/European Organisation for Research and Treatment of Cancer(EORTC) Late Radiation Morbility Scoring Schema
Quality of Life (QoL) assessment in the two groups
changes in QoL after treatment assessed using a specific EORTC questionnaire developed to assess the quality of life of palliative cancer care patients (C15-PAL)
Full Information
NCT ID
NCT03804073
First Posted
January 11, 2019
Last Updated
January 21, 2019
Sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna
1. Study Identification
Unique Protocol Identification Number
NCT03804073
Brief Title
Short Course Radiation Therapy in Palliative Treatment of Head and Neck Cancer
Official Title
SHort Course Accelerated RadiatiON Therapy (SHARON) in Palliative Treatment of Head and Neck Cancer: an Interventional, Randomized, Multicentric Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Recruiting
Study Start Date
November 8, 2017 (Actual)
Primary Completion Date
November 8, 2022 (Anticipated)
Study Completion Date
November 8, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Aim of the study is to assess efficacy of a short course radiation treatment in patients with symptomatic head and neck (H&N) malignant lesions
Detailed Description
Standard treatment for H&N lesions (3000 cGy in 10 daily fractions of 300 cGy each) is compared with experimental treatment (2000 cGy in 4 fractions of 500 cGy twice a day) to demonstrate non-inferiority of this scheme
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer, Radiotherapy, Palliative Care
Keywords
Short Course Radiotherapy, Symptomatic head and neck lesions
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
82 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
standard treatment
Arm Type
Active Comparator
Arm Description
patients in this group are treated with 3000 cGy in 10 daily fraction
Arm Title
short course treatment
Arm Type
Experimental
Arm Description
patients in this group are treated with 2000 cGy in 4 fractions administered twice a day (at least 6-8 hours interval)
Intervention Type
Radiation
Intervention Name(s)
standard treatment
Intervention Description
3000 cGy in 10 daily fractions
Intervention Type
Radiation
Intervention Name(s)
short course treatment
Intervention Description
2000 cGy in 4 fractions administered twice a day
Primary Outcome Measure Information:
Title
Efficacy of palliation using the short course scheme compared with the standard scheme
Description
reduction of initial symptoms (pain, bleeding, dysphagia, hoarseness, stridor, dehydration, malnutrition) after radiotherapy, evaluated as none-mild-moderate-severe before and after treatment
Time Frame
3 months
Secondary Outcome Measure Information:
Title
acute toxicity in the two treatment groups
Description
incidence of treatment-related acute adverse events in the two arms of the study registered using Radiation Therapy Oncology Group (RTOG) Cooperative Group Common Toxicity Criteria
Time Frame
3 months
Title
late toxicity in the two treatment groups
Description
incidence of treatment-related adverse events in the two arms of the study registered using RTOG/European Organisation for Research and Treatment of Cancer(EORTC) Late Radiation Morbility Scoring Schema
Time Frame
12 months
Title
Quality of Life (QoL) assessment in the two groups
Description
changes in QoL after treatment assessed using a specific EORTC questionnaire developed to assess the quality of life of palliative cancer care patients (C15-PAL)
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
symptomatic H&N malignant lesions (primary solid tumors or metastases from solid tumor)
age>18 years
Eastern Cooperative Oncology Group (ECOG) Performance Status 0-3
no changes in supportive care in the week before radiotherapy
Exclusion Criteria:
pregnancy
previous irradiation of the same region
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alessio G Morganti, MD
Phone
0512143564
Ext
+39
Email
alessio.morganti2@unibo.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alessio G Morganti, MD
Organizational Affiliation
Radiation Oncology Center, Department of Experimental, Diagnostic and Speciality Medicine-DIMES, Unversity of Bologna, S. Orsola-Malpighi Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Radiation Oncology Center, Department of Experimental, Diagnostic and Speciality Medicine- DIMES, University of Bologna, S.Orsola-Malpighi Hospital
City
Bologna
State/Province
BO
ZIP/Postal Code
40138
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alessio G Morganti, MD
Phone
0512143564
Ext
+39
Email
alessio.morganti2@unibo.it
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Short Course Radiation Therapy in Palliative Treatment of Head and Neck Cancer
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