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Mantle Irradiation for Hodgkin's Disease

Sponsor
Dana-Farber Cancer Institute (Other)
Overall Status
Completed
CT.gov ID
NCT00165269
Collaborator
Brigham and Women's Hospital (Other), Massachusetts General Hospital (Other)
100
Enrollment
2
Locations
189
Duration (Months)
50
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Mantle irradiation
 Phase 2

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
100 participants
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
Study Start Date :
May 1, 1992
Actual Primary Completion Date :
Jun 1, 2000
Actual Study Completion Date :
Feb 1, 2008

Outcome Measures

Primary Outcome Measures

  1. To evaluate the risks and benefits of mantle field irradiation alone in treating Hodgkin disease patients. [5 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Dana-Farber Cancer Center Boston Massachusetts United States 02115
2 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00165269
Other Study ID Numbers:
  • 92-035
First Posted:
Sep 14, 2005
Last Update Posted:
Nov 1, 2009
Last Verified:
Oct 1, 2009
Keywords provided by , ,
Hodgkin's Disease Stage IA-IIA
mantle irradiation
Additional relevant MeSH terms:
Hodgkin Disease

Study Results

No Results Posted as of Nov 1, 2009