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A Comprehensive Study of Clinically Staged Pediatric Hodgkin's Disease: Chemotherapy for All Patients; Supplementary Low Dose Involved Field Irradiation for Selected Patients (CCG 5942)


Phase 2
N/A
21 Years
Not Enrolling
Both
Pediatric, Hodgkin's Disease

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Trial Information

A Comprehensive Study of Clinically Staged Pediatric Hodgkin's Disease: Chemotherapy for All Patients; Supplementary Low Dose Involved Field Irradiation for Selected Patients (CCG 5942)

Inclusion Criteria


- Age less than 21 years at diagnosis

- Previously untreated, pathologically confirmed diagnosis of Hodgkin's disease.

- Informed patient/parental consent as required by individual institution and in
accordance with the Dept of Health and Human Services

- Approval of this protocol by the individual institutional Human Subjects Review
Committee.

- Indicate Hodgkin's disease clinical stage.

- Indicate presence or absence of "B" symptoms.

- For Stage I and II disease indicate the following:

- presence or absence of bulk disease

- number of involved nodal regions

- presence or absence of hilar adenopathy

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Determine the role of adjuvant low dose involved field radiotherapy in pediatric patients with Hodgkin's disease who attain a complete response following initial chemotherapy

Outcome Time Frame:

Conclusion of the study

Safety Issue:

No

Principal Investigator

Tanya Trippett, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

96-016

NCT ID:

NCT00592111

Start Date:

March 1996

Completion Date:

January 2008

Related Keywords:

  • Pediatric
  • Hodgkin's Disease
  • Pediatric
  • Hodgkin's Disease
  • 96-016
  • Hodgkin Disease

Name

Location
Memorial Sloan Kettering Cancer Center New York, New York  10021