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Mantle Irradiation for Hodgkin's Disease

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00165269
Enrollment
100
Registered
2005-09-14
Start date
1992-05-31
Completion date
2008-02-29
Last updated
2009-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hodgkin's Disease

Keywords

Hodgkin's Disease Stage IA-IIA, mantle irradiation

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.

Interventions

PROCEDUREMantle irradiation

Limited to above the diaphragm

Sponsors

Brigham and Women's Hospital
CollaboratorOTHER
Massachusetts General Hospital
CollaboratorOTHER
Dana-Farber Cancer Institute
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frame
To evaluate the risks and benefits of mantle field irradiation alone in treating Hodgkin disease patients.5 years

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026