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NCT00592111 Clinical Trial

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)

Hodgkin's Disease Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00592111
Other study ID # 96-016
Secondary ID CCG 5942CA42764
Status Completed
Phase Phase 2
First received December 26, 2007
Last updated December 21, 2015
Start date March 1996
Est. completion date January 2008

Study information
Verified date December 2015
Source Memorial Sloan Kettering Cancer Center
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 21
Est. completion date January 2008
Est. primary completion date February 1999
Accepts healthy volunteers No
Gender Both
Age group N/A to 21 Years
Eligibility - 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

Study Design

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

Related Conditions & MeSH terms

Intervention

Drug:
• COPP/ABV
4 courses of COPP/ABV hybrid
• COPP/ABV
6 courses of COPP/ABV hybrid
• intensive chemo with concurrent growth factor
6 cycles (2 courses) of intensive chemotherapy with concurrent growth factor

Locations
Country Name City State
United States Memorial Sloan Kettering Cancer Center New York New York

Sponsors (2)
Lead Sponsor Collaborator
Memorial Sloan Kettering Cancer Center Children's Cancer Group

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Conclusion of the study No
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