Mantle Irradiation for Hodgkin's Disease | NCT00165269

Studies
Mantle Irradiation for Hodgkin's Disease

NCT00165269

Sponsor

Dana-Farber Cancer Institute

Status

Completed

Last Update Posted

Nov 2, 2009Estimated

Enrollment

100Actual

Phase

Phase 2

Conditions

Hodgkin's Disease

Interventions

Mantle irradiation

Countries

United States

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

Oct 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1992

Primary Completion Date

Jun 2000Actual

Completion Date

Feb 2008Actual

First Submitted Date

Sep 9, 2005

First Submission Date that Met QC Criteria

Sep 9, 2005

First Posted Date

Sep 14, 2005Estimated

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

Oct 30, 2009

Last Update Posted Date

Nov 2, 2009Estimated

Name	Class
Brigham and Women's Hospital	OTHER
Massachusetts General Hospital	OTHER

Description Module

Brief Summary

The purpose of this study it to evaluate the effectiveness of radiation therapy limited to above the diaphragm in patients with pathological stage IA-IIA Hodgkin's disease.

Detailed Description

Eligble patients will receive a course of radiation therapy directed to above the diaphragm only.
Patients would have bloodwork and chest x-rays performed 4 times per year for the first two years, 3 times per year for the third year, and 2 times per year for the fourth and fifth years. After five years, yearly check-ups are performed.
In addition to the above follow-up, patients will receive, once or twice a year for the first 5 years, an abdominal-pelvic CT scan and/or gallium scan.

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

100Actual

Name	Type	Description	Arm Group Labels	Other Names
Mantle irradiation	Procedure	Limited to above the diaphragm

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To evaluate the risks and benefits of mantle field irradiation alone in treating Hodgkin disease patients.		5 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Pathologically Stage IA-IIA Hodgkin's disease
A negative staging laparotomy including splenectomy, biopsies of liver, paraortic nodal biopsies and palpitation of upper pelvic nodes
18 years of age or older

Exclusion Criteria:

Patients with large mediastinal adenopathy
Patients with LD histology
Patients with "B" symptoms
Positive laparotomy
Subcarinal, hilar, or cardiac lymph node involvement

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

Not provided

Overall Officials

Name	Affiliation	Role
Peter Mauch, MD	Dana-Farber Cancer Institute	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dana-Farber Cancer Center		Boston	Massachusetts	02115	United States
Massachusetts General Hospital

Condition Browse Module

MeSH Terms

ID	Term
D006689	Hodgkin Disease

Ancestor Terms

ID	Term
D008223	Lymphoma
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D008232	Lymphoproliferative Disorders

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Browse Branches

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