Mantle Irradiation for Hodgkin's Disease

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.

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Key information

Conditions

Hodgkin's Disease Hemic and Lymphatic Diseases Hodgkin Disease Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Dana-Farber Cancer Center, Boston, Massachusetts, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mantle irradiation

Procedure

Limited to above the diaphragm

Primary outcomes

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

Time frame: 5 years

Sponsors and collaborators

Lead sponsor

Dana-Farber Cancer Institute

Other

Collaborators

Brigham and Women's Hospital
Massachusetts General Hospital

Registry information

Official study title

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

Important dates

Study start: 1992
Primary completion: 2000
Study completion: 2008
First posted: Sep 14, 2005
Registry last updated: Nov 2, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed