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CompletedNCT00165269Updated Nov 1, 2009

Mantle Irradiation for Hodgkin's Disease

A Phase 2 interventional study of Mantle irradiation in Hodgkin's Disease, sponsored by Dana-Farber Cancer Institute. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2009-11-01.

Sponsored by Dana-Farber Cancer Institute · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
100
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.
02

Conditions studied

  • Hodgkin's Disease

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Keywords

  • Hodgkin's Disease Stage IA-IIA
  • mantle irradiation
03

In context

Hodgkin Disease

885 studies on the registry are indexed under Hodgkin Disease; 132 are open to participants now.

This study's enrollment of 100 is above the median of 44 across 726 interventional studies indexed under Hodgkin Disease.

Browse Hodgkin Disease studies →

Lead sponsor

Dana-Farber Cancer Institute is the lead sponsor of 813 studies on the registry; 124 are open to participants now.

Of its 113 completed or terminated interventional studies of FDA-regulated products, 77 (68%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

Exclusion Criteria:

  • Patients with large mediastinal adenopathy
  • Patients with LD histology
  • Patients with "B" symptoms
  • Positive laparotomy
  • Subcarinal, hilar, or cardiac lymph node involvement
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (actual)

Interventions

  • ProcedureMantle irradiation

    Limited to above the diaphragm

06

What researchers measure

Primary outcomes

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

    Time frame: 5 years

07

Study locations

2 sites
  • Dana-Farber Cancer Center
    Boston, Massachusetts 02115, United States
  • Massachusetts General Hospital
    Boston, Massachusetts 02115, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 1, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00165269
Lead sponsor
Dana-Farber Cancer Institute
Collaborators
Brigham and Women's Hospital, Massachusetts General Hospital
First posted
Sep 14, 2005
Start date
May 1992
Primary completion
Jun 2000
Completion
Feb 2008
Last update
Nov 1, 2009

Study contacts

Peter Mauch, MD
principal investigator · Dana-Farber Cancer Institute
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2009. You cannot join it, but the record below documents what was studied.

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