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Clinical Trials/NCT00165269
NCT00165269CompletedPhase 2

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

Dana-Farber Cancer Institute2 sites in 1 country100 target enrollmentStarted: May 1, 1992Last updated:
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Conditions

Trial Snapshot

Phase
Phase 2
Status
Completed
Enrollment
100
Locations
2
Primary Endpoint
To evaluate the risks and benefits of mantle field irradiation alone in treating Hodgkin disease patients.
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

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
Allocation
Non Randomized
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
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

Outcomes

Primary Outcomes

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

Time Frame: 5 years

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other

Study Sites (2)

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