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Chemotherapy Based on PET Scan in Treating Patients With Stage I or Stage II Hodgkin Lymphoma

This study has been terminated.
(Slow accrual)
National Cancer Institute (NCI)
Eastern Cooperative Oncology Group
Information provided by (Responsible Party):
American College of Radiology Imaging Network Identifier:
First received: July 7, 2011
Last updated: March 16, 2017
Last verified: March 2017

RATIONALE: Drugs used in chemotherapy, such as doxorubicin hydrochloride, bleomycin sulfate, vinblastine, dacarbazine, cyclophosphamide, etoposide, procarbazine hydrochloride, vincristine sulfate, and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x rays to kill cancer cells. Giving combination chemotherapy together with radiation therapy may kill more cancer cells. Comparing results of imaging procedures, such as PET scans and CT scans, done before, during, and after chemotherapy may help doctors predict a patient's response to treatment and help plan the best treatment.

PURPOSE: This phase II clinical trial studies how well chemotherapy based on PET/CT scan works in treating patients with stage I or stage II Hodgkin lymphoma.

Condition Intervention Phase
Lymphoma Biological: bleomycin sulfate Drug: ABVD regimen Drug: BEACOPP regimen Drug: cyclophosphamide Drug: dacarbazine Drug: doxorubicin hydrochloride Drug: etoposide Drug: prednisone Drug: procarbazine hydrochloride Drug: vinblastine Drug: vincristine sulfate Other: laboratory biomarker analysis Procedure: computed tomography Radiation: fludeoxyglucose F 18 Radiation: selective external radiation therapy Phase 2

Study Type: Interventional
Study Design: Masking: No masking
Primary Purpose: Treatment
Official Title: Phase II Trial of Response-Adapted Therapy Based on Positron Emission Tomography (PET) for Bulky Stage I and II Classical Hodgkin Lymphoma (HL)

Resource links provided by NLM:

Further study details as provided by American College of Radiology Imaging Network:

Primary Outcome Measures:
  • 36-month progression-free survival

Secondary Outcome Measures:
  • PET-positive rate
  • PET-negative rate
  • Complete response
  • Toxicity of response-adapted chemotherapy

Estimated Enrollment: 200
Study Start Date: April 2012
Study Completion Date: January 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
  Show Detailed Description


Ages Eligible for Study:   18 Years to 120 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically proven classical Hodgkin lymphoma subclassified according to the World Health Organization (WHO) Classification of Tumors, 4th edition (2008)

    • Nodular lymphocyte-predominant Hodgkin lymphoma is excluded
  • Patients must have clinical stage IA, IB, IIA, or IIB disease

    • Patients with "E" extensions will be eligible if all other criteria have been met
  • Patients must have a mediastinal mass > 0.33-cm maximum intrathoracic diameter on standing postero-anterior chest x-ray or measuring > 10 cm in its largest diameter on axial CT images
  • Bone marrow biopsy is required


  • ECOG performance status 0-2
  • ANC ≥ 1,000/μL
  • Platelet count ≥ 100,000/μL
  • Hemoglobin ≥ 10 g/dL
  • Serum creatinine ≤ 2 mg/dL
  • Direct bilirubin ≤ 2 mg/dL
  • AST/ALT ≤ 2 times upper limit of normal
  • Not pregnant or nursing
  • Negative pregnancy test
  • Women of childbearing potential and sexually active males must be strongly advised to use an accepted and effective method of contraception
  • No "currently active" second malignancy other than non-melanoma skin cancers

    • Patients are not considered to have a "currently active" malignancy if they have completed therapy and are considered by their physician to be at less than 30% risk of relapse
  • LVEF by ECHO or MUGA normal unless thought to be disease related
  • DLCO ≥ 60% with no symptomatic pulmonary disease unless thought to be disease related
  • Patients with a history of intravenous drug abuse, or any behavior associated with an increased risk of HIV infection, should be tested for exposure to the HIV virus, and an HIV test is required for entry on this protocol
  • HIV-positive patients are eligible if they have CD4 counts ≥ 400/mm³ and are on concurrent antiretrovirals

    • Patient HIV status must be known prior to registration
    • HIV-positive patients must not have multi-drug resistant HIV infections; CD4 counts < 400/mm³; or other concurrent AIDS-defining conditions


  • No prior treatment (chemotherapy or radiation therapy) for Hodgkin lymphoma
  • Concurrent antiretroviral therapy for HIV-positive patients (CD4 counts ≥ 400/mm³) allowed
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01390584

United States, California
Stanford Cancer Center
Stanford, California, United States, 94305-5824
United States, Pennsylvania
McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center
Reading, Pennsylvania, United States, 19612-6052
Sponsors and Collaborators
American College of Radiology Imaging Network
National Cancer Institute (NCI)
Eastern Cooperative Oncology Group
Principal Investigator: Ranjana Advani, MD Stanford University
  More Information

Responsible Party: American College of Radiology Imaging Network Identifier: NCT01390584     History of Changes
Other Study ID Numbers: CDR0000702859
ECOG-E2410, ACRIN 6700 ( Other Identifier: ACRIN Foundation )
U01CA079778 ( US NIH Grant/Contract Award Number )
U01CA080098 ( US NIH Grant/Contract Award Number )
Study First Received: July 7, 2011
Last Updated: March 16, 2017
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by American College of Radiology Imaging Network:
stage I adult Hodgkin lymphoma
stage II adult Hodgkin lymphoma
adult favorable prognosis Hodgkin lymphoma
adult mixed cellularity Hodgkin lymphoma
adult nodular sclerosis Hodgkin lymphoma
adult lymphocyte depletion Hodgkin lymphoma
adult unfavorable prognosis Hodgkin lymphoma

Additional relevant MeSH terms:
Hodgkin Disease
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Liposomal doxorubicin
Fluorodeoxyglucose F18
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Anti-Inflammatory Agents
Glucocorticoids processed this record on June 27, 2017