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Mantle Irradiation for Hodgkin's Disease

Primary Purpose

Hodgkin's Disease

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Mantle irradiation

About this trial

This is an interventional treatment trial for Hodgkin's Disease focused on measuring Hodgkin's Disease Stage IA-IIA, mantle irradiation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Dana-Farber Cancer Center
Massachusetts General Hospital

Outcomes

Primary Outcome Measures

To evaluate the risks and benefits of mantle field irradiation alone in treating Hodgkin disease patients.

Secondary Outcome Measures

Full Information

NCT ID

NCT00165269

First Posted

September 9, 2005

Last Updated

October 30, 2009

Sponsor

Dana-Farber Cancer Institute

Collaborators

Brigham and Women's Hospital, Massachusetts General Hospital

1. Study Identification

Unique Protocol Identification Number

NCT00165269

Brief Title

Mantle Irradiation for Hodgkin's Disease

Official Title

Mantle Irradiation for Selected Hodgkin's Disease Patients With Stage IA-IIA Disease

Study Type

Interventional

2. Study Status

Record Verification Date

October 2009

Overall Recruitment Status

Completed

Study Start Date

May 1992 (undefined)

Primary Completion Date

June 2000 (Actual)

Study Completion Date

February 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Dana-Farber Cancer Institute

Collaborators

Brigham and Women's Hospital, Massachusetts General Hospital

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hodgkin's Disease

Keywords

Hodgkin's Disease Stage IA-IIA, mantle irradiation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

100 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Procedure

Intervention Name(s)

Mantle irradiation

Intervention Description

Limited to above the diaphragm

Primary Outcome Measure Information:

Title

To evaluate the risks and benefits of mantle field irradiation alone in treating Hodgkin disease patients.

Time Frame

5 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Peter Mauch, MD

Organizational Affiliation

Dana-Farber Cancer Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Dana-Farber Cancer Center

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02115

Country

United States

Facility Name

Massachusetts General Hospital

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02115

Country

United States

12. IPD Sharing Statement

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Mantle Irradiation for Hodgkin's Disease

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