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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)

Information source: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pediatric; Hodgkin's Disease

Intervention: COPP/ABV (Drug); COPP/ABV (Drug); intensive chemo with concurrent growth factor (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Memorial Sloan Kettering Cancer Center

Official(s) and/or principal investigator(s):
Tanya Trippett, MD, Principal Investigator, Affiliation: Memorial Sloan Kettering Cancer Center

Summary

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.

Clinical Details

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

Primary outcome: 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

Eligibility

Minimum age: N/A. Maximum age: 21 Years. Gender(s): Both.

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

Locations and Contacts

Memorial Sloan Kettering Cancer Center, New York, New York 10065, United States
Additional Information

Starting date: March 1996
Last updated: July 20, 2011

Page last updated: August 23, 2015

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