Search / Trial NCT00002561

Radiation Therapy and Chemotherapy in Treating Patients With Hodgkin's Disease

Launched by NCIC CLINICAL TRIALS GROUP · Nov 20, 2003

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Trial Information

Current as of January 02, 2025

Completed

Keywords

Stage I Adult Hodgkin Lymphoma Stage Ii Adult Hodgkin Lymphoma Adult Lymphocyte Predominant Hodgkin Lymphoma Adult Lymphocyte Depletion Hodgkin Lymphoma Adult Nodular Sclerosis Hodgkin Lymphoma Adult Mixed Cellularity Hodgkin Lymphoma

ClinConnect Summary

OBJECTIVES: I. Compare the 12-year survival of patients with clinical stage I-IIA Hodgkin's disease treated with radiotherapy with or without doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) versus ABVD only. II. Compare the freedom from progression at 5 and 10 years in patients treated with these regimens. III. Compare the complete remission rate, freedom from secondary disease progression at 5 and 10 years, and cause-specific survival at 5, 10, and 15 years in patients treated with these regimens. IV. Compare the short- and long-term toxicity of these regimens in these patients...

Gender

ALL

Eligibility criteria

  • • Eligibility Criteria
  • • Histologically proven Hodgkin's Disease. A needle aspirate specimen will not be considered sufficient for diagnosis.
  • • Pathologic material must have been reviewed by a designated local reference pathologist (LRP) prior to randomization. Histologic subtype determined by the LRP will be used for patient cohort assignment.
  • * Patients must have clinical stage I - IIA disease according to Ann Arbor staging criteria. Clinical stage must be based on at least one tissue biopsy. The following aspects are to be considered in determining patient stage:
  • • i) Splenic Enlargement: Splenic enlargement determined by imaging studies only should not be considered evidence of splenic involvement with Hodgkin's disease. Patients should be considered as having splenic involvement if the spleen is palpable on physical examination and enlarged on imaging studies, or imaging studies show focal abnormalities consistent with Hodgkin's disease. These patients, if presenting with supradiaphragmatic disease would therefore be assessed as having Stage III disease and would be ineligible.
  • • ii) Bone Disease: Lytic or blastic lesions seen on plain radiographs or abnormalities on bone scan consistent with Hodgkin's disease will be considered as bone involvement with Hodgkin's disease. These patients would therefore be assessed as having Stage IV disease and would be ineligible.
  • • iii) Pleural Effusion and Ascites: The presence of a pleural effusion or ascites will be considered as evidence of Hodgkin's disease even if cytological examination is negative. These patients would be assessed as having probable Stage IV disease and therefore would be ineligible. Patients assessed on Xray as having pleural thickening or "blunting" of the costophrenic angle only may be eligible. iv) Extra-nodal vs. Stage IV Disease: Patients with disease involving a single extra-nodal site may be considered as "limited-stage" provided all disease can be included in a standard radiation field. Patients with extra-nodal disease that cannot be included in such a field (eg, lung, bone) or with multiple sites of extra-nodal disease are not eligible for this trial.
  • • Pulmonary function tests must be done in patients with symptomatic lung disease. FVC, FEV-1 and DLCO must be ≥ 60% of predicted value. Patients with asthma controlled by medication are eligible if the above criteria are met.
  • • Patient's age is ≥ 16 years. (Note that the lower age limit at each centre will be determined by that centre's policy regarding the age at which an individual may sign their own consent.)
  • • Patient must not have received previous chemotherapy or radiotherapy.
  • * Laboratory requirements:
  • • granulocytes ≥ 1.5 x 109/L (S.I.) or ≥ 1.5 x 103/uL (U.S.) platelets ≥ 125 x 109/L (S.I.) or ≥ 125 x 103/uL (U.S.) bilirubin ≤ 2.5 x UNL (unless due to hemolytic anemia) serum creatinine ≤ 2 x UNL
  • • Patient must have been seen by both a radiation oncologist and medical oncologist who agree the patient is able to receive protocol radiation therapy.
  • • Patient consent must be obtained according to local Institutional and/or University Human Experimentation Committee requirements. It will be the responsibility of the local participating investigators to obtain the necessary local clearance, and to indicate in writing to the NCIC CTG Clinical Trials Coordinator that such clearance has been obtained, before the trial can commence in that centre. Because of differing requirements, a standard consent form for the trial will not be provided but a sample form is given. The patient must sign the consent form prior to randomization. Please note that the consent form for this study must contain a statement which gives permission for the NCICCTG and monitoring agencies to review patient records.
  • • Availability of patient for follow-up and quality of life (QoL) assessments. Patients must be accessible for treatment and follow-up. Investigators must assure themselves that patients registered on this trial will be available for complete documentation of the treatment, toxicity and follow-up. Comparison of quality of life is an end-point of this study. Patients must have completed the pre-randomization quality of life assessment and be willing to complete future assessments. The only exceptions will be patients who are unable to read english or french. Patients on study are expected to complete all the quality of life assessments but, should this not prove possible, they will be retained in the study for all other analyses.
  • • Ineligibility Criteria
  • • Prior or concurrent malignancies, except adequately treated basal cell carcinoma of the skin. (Patients with prior carcinoma-in-situ of the cervix are not eligible.)
  • • Cardiac disease defined as symptomatic congestive heart failure or coronary artery disease, known valvular (other than asymptomatic mitral valve prolapse) or congenital heart disease (other than asymptomatic atrial septal defects) or need for cardiac medications. Hypertension controlled with drug therapy is not an exclusion criterion.
  • • Other major medical illness judged likely by the local investigator to preclude safe administration of protocol treatment or required follow-up.
  • * Patients with stage IA disease (who might be treated with involved-field only irradiation) defined by meeting all of the following criteria:
  • • i) lymphocyte predominant or nodular sclerosing histology ii) disease bulk \< 3 cm iii) erythrocyte sedimentation rate (ESR) \< 50 iv) unilateral high - neck only disease, defined as disease located above the upper border of the thyroid cartilage or isolated epitrochlear adenopathy
  • • Patients with very unfavourable clinical stage I-IIA disease defined as bulky adenopathy. Bulky adenopathy is defined as a palpable nodal mass greater than 10 cm. in diameter or a mediastinal mass with a maximum mass diameter measuring greater than or equal to 1/3 the maximum chest wall diameter (see Appendix III).
  • • Patients with intra-abdominal disease. (Patients with pelvic disease: ileofemoral, inguinal or parailiac nodes are eligible for this study.)
  • • Patients with B symptoms.
  • • Patients known to have a positive antibody test for the human immunodeficiency virus (HIV) or who have a clinical diagnosis of acquired immunodeficiency syndrome. HIV testing is not a requirement for study entry.
  • • Patients who have undergone a staging laparotomy.
  • • Female patients who are pregnant. Note: men and women of childbearing age must be advised in the use of adequate contraception.

Trial Officials

Ralph M. Meyer, MD, FRCPC

Study Chair

Margaret and Charles Juravinski Cancer Centre

Jane N. Winter, MD

Study Chair

Robert H. Lurie Cancer Center

About Ncic Clinical Trials Group

The NCIC Clinical Trials Group (NCIC CTG) is a leading Canadian organization dedicated to advancing cancer research through the design, conduct, and analysis of clinical trials. As part of the Canadian Cancer Society, NCIC CTG collaborates with various academic institutions, healthcare professionals, and industry partners to develop innovative treatment strategies and improve patient outcomes. The group focuses on a diverse range of cancer types and strives to enhance the understanding of cancer biology, treatment efficacy, and supportive care, thereby contributing to the global knowledge base in oncology. Through rigorous scientific methodologies and a commitment to ethical standards, NCIC CTG plays a pivotal role in shaping the future of cancer care.

Locations

Southampton, England, United Kingdom

St. John's, Newfoundland And Labrador, Canada

Calgary, , Canada

Edmonton, , Canada

Hamilton, , Canada

Newmarket, , Canada

Oshawa, , Canada

Regina, , Canada

Saskatoon, , Canada

Sault Ste. Marie, , Canada

Victoria, , Canada

Moncton, New Brunswick, Canada

Saint John, New Brunswick, Canada

Halifax, Nova Scotia, Canada

Mississauga, Ontario, Canada

Sudbury, Ontario, Canada

Toronto, Ontario, Canada

Toronto, Ontario, Canada

Toronto, Ontario, Canada

Montreal, Quebec, Canada

Brescia, , Italy

Perugia, , Italy

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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