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


Phase 2
18 Years
N/A
Not Enrolling
Both
Hodgkin's Disease

Thank you

Trial Information

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


- 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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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

Outcome Time Frame:

5 years

Safety Issue:

Yes

Principal Investigator

Peter Mauch, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute

Authority:

United States: Institutional Review Board

Study ID:

92-035

NCT ID:

NCT00165269

Start Date:

May 1992

Completion Date:

February 2008

Related Keywords:

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

Name

Location
Massachusetts General Hospital Boston, Massachusetts  02114-2617
Dana-Farber Cancer Center Boston, Massachusetts  02115