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Mantle Irradiation for Hodgkin's Disease

This study has been completed.
Sponsor:
Collaborators:
Brigham and Women's Hospital
Massachusetts General Hospital
Information provided by:
Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00165269
First received: September 9, 2005
Last updated: October 30, 2009
Last verified: October 2009
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:

U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Peter Mauch, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00165269     History of Changes
Other Study ID Numbers: 92-035
Study First Received: September 9, 2005
Last Updated: October 30, 2009
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on June 17, 2013