Palliative Short Course Radiotherapy for Advanced Thoracic Cancer

NCT ID: NCT03465553

Last Updated: 2018-03-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-01

Study Completion Date

2018-01-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Palliative Care

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Short course radiotherapy

The radiotherapy is delivered over 2 days with accelerated hypo-fractionation.

Group Type EXPERIMENTAL

Short course radiotherapy

Intervention Type RADIATION

An accelerated hypo-fractionation radiotherapy is delivered for palliation in patients with advanced thoracic cancer

Interventions

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Short course radiotherapy

An accelerated hypo-fractionation radiotherapy is delivered for palliation in patients with advanced thoracic cancer

Intervention Type RADIATION

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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IRCCS Azienda Ospedaliero-Universitaria di Bologna

OTHER

Sponsor Role lead

Responsible Party

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Alessio Giuseppe Morganti

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alessio G. Morganti, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Bologna, , Italy

Site Status

Countries

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Italy

References

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Farina E, Macchia G, Buwenge M, Siepe G, Zamagni A, Cammelli S, Cilla S, Wondemagegnhu T, Woldemariam AA, Uddin AFMK, Sumon MA, Cellini F, Deodato F, Morganti AG. Radiotherapy in palliation of thoracic tumors: a phase I-II study (SHARON project). Clin Exp Metastasis. 2018 Dec;35(8):739-746. doi: 10.1007/s10585-018-9942-6. Epub 2018 Oct 8.

Reference Type DERIVED
PMID: 30298381 (View on PubMed)

Other Identifiers

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SHARON LUNG

Identifier Type: -

Identifier Source: org_study_id

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