Palliative Short Course Radiotherapy for Advanced Thoracic Cancer

Palliative Care Clinical Trial

Official title:

Palliative Short Course Accelerated Radiation Therapy for Advanced Thoracic Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03465553
• Other study ID #: SHARON LUNG
• Status: Completed
• Phase: N/A
• First received: March 8, 2018
• Last updated: March 8, 2018
• Start date: January 1, 2009
• Est. completion date: January 1, 2018

Study information

• Verified date: March 2018
• Source: Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

The study wants to define the maximum tolerated dose (MTD) of a conformal short course accelerated radiation therapy delivered in twice daily fractions and 2 consecutive days, and the feasibility of this fractionation in term of safety and efficacy for symptomatic palliation of advanced thoracic cancer.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: January 1, 2018
• Est. primary completion date: January 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• histologically proven advanced thoracic 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) <3

Exclusion Criteria:

• prior radiotherapy to the same region

Related Conditions & MeSH terms

• Palliative Care

Intervention

Radiation:
• Short course radiotherapy
An accelerated hypo-fractionation radiotherapy is delivered for palliation in patients with advanced thoracic cancer

Locations

Country	Name	City	State
Italy	Radiation Oncology Center, Dept. of Experimental, Diagnostic and Specialty Medicine - DIMES, University of Bologna, S.Orsola-Malpighi Hospital	Bologna

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Acute toxicity	Acute toxicity after treatment is evaluated with the Common Terminology Criteria for Adverse Events (CTCAE). Values range from 1 (minimum acute toxicity) to 5 (maximum acute toxicity).	1 year
Secondary	Quality of life	Quality of life after the treatment is evaluated according with the Cancer Linear Analog Scale (CLAS). Values range from 0 (better status) to 10 (worst status).	1 year
Secondary	Pain relief	Pain after treatment is evaluated with the Visual Analogic scale (VAS). Values range from 0 (no pain) to 10 (maximum possible pain).	1 year
Secondary	Late toxicity	Late toxicity after the treatment is evaluated with the Toxicity criteria of the Radiation Therapy Oncology Group and the European Organization for Research and Treatment of Cancer (RTOG/EORTC). Values range from 1 (minimum late toxicity) to 5 (maximum/severe late toxicity).	1 year