Mantle Irradiation for Hodgkin's Disease

Hodgkin's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00165269
• Other study ID #: 92-035
• Status: Completed
• Phase: Phase 2
• First received: September 9, 2005
• Last updated: October 30, 2009
• Start date: May 1992
• Est. completion date: February 2008

Study information

• Verified date: October 2009
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: February 2008
• Est. primary completion date: June 2000
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hodgkin Disease
• Hodgkin's Disease

Intervention

Procedure:
• Mantle irradiation
Limited to above the diaphragm

Locations

Country	Name	City	State
United States	Dana-Farber Cancer Center	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute	Brigham and Women's Hospital, Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the risks and benefits of mantle field irradiation alone in treating Hodgkin disease patients.		5 years	Yes