Low-dose Radiotherapy for Diffuse Large B-cell Lymphoma | NCT02803840

Studies
Low-dose Radiotherapy for Diffuse Large B-cell Lymphoma

NCT02803840

Sponsor

Centro di Riferimento Oncologico - Aviano

Status

Unknown status

Last Update Posted

Jun 17, 2016Estimated

Enrollment

25Estimated

Phase

Phase 2

Conditions

Lymphoma

Interventions

Low-dose radiotherapy

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2011

Primary Completion Date

Jun 2016Actual

Completion Date

Jun 2016Estimated

First Submitted Date

Jun 9, 2016

First Submission Date that Met QC Criteria

Jun 16, 2016

First Posted Date

Jun 17, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 16, 2016

Last Update Posted Date

Jun 17, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Patients with Diffuse Large B-cell Lymphoma with indication for palliative radiotherapy are treated with low-dose radiation (2 x 2 Gy) to the symptomatic sites only. The primary endpoint of the study is the response rate and Quality of Life of the patients (QoL).

Detailed Description

Response is planned at 21-day after completion of the treatment. Response assessment is based on the standard definitions of the World Health Organization using complete response (CR), partial response (PR), stable disease (SD), and progressive disease (PD) as response assessment criteria. The efficacy of the treatment consisted of a reduction greater than 50% of the maximum diameter of the radiated mass (PR + CR). QoL is evaluated using the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 3.0 version questionnaire. The QLQ-C30 questionnaire is self administered to the patients at baseline and at 21 days after treatment.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

25Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Experimental	Other	DLBCL patients with indication for palliative radiotherapy	Radiation: Low-dose radiotherapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Low-dose radiotherapy	Radiation	2 x 2 Gy on symptomatic sites only	Experimental

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Response rate	Clinical response is defined as reduction > 50% of maximum diameter of the radiated lesion	Clinical response up to 21 days after treatment

Secondary Outcomes

Measure	Description	Time Frame
Quality of life according to the EORTC QLQ-C30 questionnaire		The QLQ-C30 questionnaire is administered at baseline and at 21 days after treatment

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with histologically proven diagnosis of DLBCL with indication for palliative radiotherapy

Exclusion Criteria:

None

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Carlo Furlan, MD	Contact	+390434659081		cfurlan@cro.it

Overall Officials

Name	Affiliation	Role
Carlo Furlan, MD	Centro di Riferimento Oncologico - Aviano	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centro di Riferimento Oncologico	Recruiting	Aviano	Pordenone	33081	Italy

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D008223	Lymphoma

Ancestor Terms

ID	Term
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D008232	Lymphoproliferative Disorders
D008206	Lymphatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided