Mantle Irradiation for Hodgkin's Disease

NCT ID: NCT00165269

Last Updated: 2009-11-02

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

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

1992-05-31

Study Completion Date

2008-02-29

Brief Summary

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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

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* 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.

Conditions

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Hodgkin's Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Mantle irradiation

Limited to above the diaphragm

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Brigham and Women's Hospital

OTHER

Sponsor Role collaborator

Massachusetts General Hospital

OTHER

Sponsor Role collaborator

Dana-Farber Cancer Institute

OTHER

Sponsor Role lead

Responsible Party

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Dana-Farber Cancer Institute

Principal Investigators

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Peter Mauch, MD

Role: PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Locations

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Dana-Farber Cancer Center

Boston, Massachusetts, United States

Site Status

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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92-035

Identifier Type: -

Identifier Source: org_study_id

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