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OpenTrials
Completed

NCT Number: NCT00592111

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)

Study Hypothesis: Clinical staging without laparotomy/splenectomy is adequate for children and young adults with Hodgkin's disease who receive chemotherapy as a component of treatment.

Completed

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Key information

Conditions

Pediatric Hemic and Lymphatic Diseases Hodgkin Disease Hodgkin's Disease Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

Up to 21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Memorial Sloan Kettering Cancer Center

New York, 10065, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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

Treatment and study plan

COPP/ABV

Drug

4 courses of COPP/ABV hybrid

Other names: Cyclophosphamide, Vincristine, Procarbazine, Prednisone, Adriamycin, Bleomycin, Vinblastine

intensive chemo with concurrent growth factor

Drug

6 cycles (2 courses) of intensive chemotherapy with concurrent growth factor

Other names: Cyclophosphamide, Vincristine, Procarbazine, Prednisone, Adriamycin, Bleomycin, Vinblastine, Cytosine Arabinoside, Etoposide, G-CSF (Filgrastim)

Primary outcomes

  1. 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

    Time frame: Conclusion of the study

Interested in participating?

Completed

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Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Collaborators

  • Children's Cancer Group

Registry information

Important dates

Study start
1996
Primary completion
1999
Study completion
2008
First posted
Jan 11, 2008
Registry last updated
Dec 23, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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