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Randomized Trial of Subtotal Nodal Irradiation Versus Doxorubicin, Vinblastine and Subtotal Nodal Irradiation for Stage I-IIA Hodgkin's Disease


Phase 3
16 Years
N/A
Open (Enrolling)
Both
Lymphoma

Thank you

Trial Information

Randomized Trial of Subtotal Nodal Irradiation Versus Doxorubicin, Vinblastine and Subtotal Nodal Irradiation for Stage I-IIA Hodgkin's Disease


OBJECTIVES: I. Compare progression-free and overall survival of patients with clinical Stage
IA/IIA Hodgkin's disease who have not undergone laparotomy and who are randomized to
treatment with subtotal nodal irradiation with vs. without 3 courses of
doxorubicin/vinblastine. II. Compare the long-term toxicities associated with these
treatments, including cardiopulmonary toxicity, secondary malignancies, and infertility.
III. Identify subgroups of patients (based on age, gender, tumor histology, number of
disease sites, and presence of high neck presentation) that are particularly responsive to
these treatments.

OUTLINE: Randomized study. Arm I: Radiotherapy. Subtotal nodal irradiation using megavoltage
equipment (4-10 MeV). Arm II: 2-Drug Combination Chemotherapy followed by Radiotherapy.
Doxorubicin, DOX, NSC-123127; Vinblastine, VBL, NSC-49842; followed by subtotal nodal
irradiation as in Arm I.

PROJECTED ACCRUAL: 210 patients/arm will be enrolled over about 7 years.

Inclusion Criteria


DISEASE CHARACTERISTICS: Biopsy-proven Hodgkin's disease, subclassified according to the
Rye system Clinical Stages IA, IEA, IIA, and IIEA according to modified Ann Arbor system
Staging laparotomy not allowed Completely resected disease allowed Residual disease, if
present, must be bidimensionally measurable No mediastinal mass greater than 1/3 the
maximum chest diameter No infradiaphragmatic presentation No pericardial E lesions (small
pericardial effusions in the absence of nodular pericardial disease allowed) Concurrent
registration on protocol SWOG-9208 (quality-of-life study) required unless patient does
not understand or read English

PATIENT CHARACTERISTICS: Age: 16 and over Performance status: SWOG 0-2 Hematopoietic: AGC
at least 2,000 Platelets within normal limits Hepatic: Bilirubin within normal limits
Renal: Creatinine within normal limits Cardiovascular: LVEF normal No serious EKG
abnormality Pulmonary: No serious pulmonary condition Other: No serious medical condition
other than Hodgkin's disease No known AIDS or HIV-associated complex No second malignancy
within 5 years except: Adequately treated nonmelanomatous skin cancer Adequately treated
in situ carcinoma of the cervix No pregnant or lactating women Adequate contraception
required of fertile patients Blood/body fluid analyses to determine eligibility completed
within 14 days prior to registration; imaging studies for tumor measurement completed
within 28 days prior to registration; screening exams other than blood/body fluid
analyses, and imaging studies of nonmeasurable disease or uninvolved organs completed
within 42 days prior to registration

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior biologic therapy Chemotherapy: No
prior chemotherapy for any reason Endocrine therapy: Not specified Radiotherapy: No prior
radiotherapy for any reason Surgery: No staging laparotomy

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

progression-free survival

Outcome Time Frame:

every 3 months while on protocol treatment, then every 6 months for 2 years, then annually thereafter

Safety Issue:

No

Principal Investigator

Oliver W. Press, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Washington

Authority:

United States: Federal Government

Study ID:

CDR0000077691

NCT ID:

NCT00002495

Start Date:

September 1992

Completion Date:

May 2015

Related Keywords:

  • Lymphoma
  • stage I adult Hodgkin lymphoma
  • stage II adult Hodgkin lymphoma
  • Hodgkin Disease
  • Lymphoma

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263
Walter Reed Army Medical CenterWashington, District of Columbia  20307-5000
University of Chicago Cancer Research CenterChicago, Illinois  60637
University of Iowa Hospitals and ClinicsIowa City, Iowa  52242
University of Massachusetts Memorial Medical CenterWorcester, Massachusetts  01655
University of Minnesota Cancer CenterMinneapolis, Minnesota  55455
Comprehensive Cancer Center of Wake Forest University Baptist Medical CenterWinston-Salem, North Carolina  27157-1082
Rhode Island HospitalProvidence, Rhode Island  02903
Vermont Cancer CenterBurlington, Vermont  05401-3498
CCOP - Southern Nevada Cancer Research FoundationLas Vegas, Nevada  89106
University of California San Diego Cancer CenterLa Jolla, California  92093-0658
CCOP - Christiana Care Health ServicesWilmington, Delaware  19899
CCOP - Mount Sinai Medical CenterMiami Beach, Florida  33140
Ellis Fischel Cancer Center - ColumbiaColumbia, Missouri  65203
Barnes-Jewish HospitalSaint Louis, Missouri  63110
Norris Cotton Cancer CenterLebanon, New Hampshire  03756
CCOP - North Shore University HospitalManhasset, New York  11030
State University of New York - Upstate Medical UniversitySyracuse, New York  13210
CCOP - Southeast Cancer Control ConsortiumWinston-Salem, North Carolina  27104-4241
University of Tennessee, Memphis Cancer CenterMemphis, Tennessee  38103
MBCCOP - Massey Cancer CenterRichmond, Virginia  23298-0037
Mount Sinai Medical Center, NYNew York, New York  10029