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Mantle Irradiation for Hodgkin's Disease

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00165269
First Posted: September 14, 2005
Last Update Posted: November 2, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Brigham and Women's Hospital
Massachusetts General Hospital
Information provided by:
Dana-Farber Cancer Institute
  Purpose
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.

Condition Intervention Phase
Hodgkin's Disease Procedure: Mantle irradiation Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Mantle Irradiation for Selected Hodgkin's Disease Patients With Stage IA-IIA Disease

Resource links provided by NLM:


Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:
  • To evaluate the risks and benefits of mantle field irradiation alone in treating Hodgkin disease patients. [ Time Frame: 5 years ]

Enrollment: 100
Study Start Date: May 1992
Study Completion Date: February 2008
Primary Completion Date: June 2000 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Mantle irradiation
    Limited to above the diaphragm
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00165269


Locations
United States, Massachusetts
Dana-Farber Cancer Center
Boston, Massachusetts, United States, 02115
Massachusetts General Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Massachusetts General Hospital
Investigators
Principal Investigator: Peter Mauch, MD Dana-Farber Cancer Institute
  More Information

Responsible Party: Peter Mauch, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00165269     History of Changes
Other Study ID Numbers: 92-035
First Submitted: September 9, 2005
First Posted: September 14, 2005
Last Update Posted: November 2, 2009
Last Verified: October 2009

Keywords provided by Dana-Farber Cancer Institute:
Hodgkin's Disease Stage IA-IIA
mantle irradiation

Additional relevant MeSH terms:
Hodgkin Disease
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases