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Spots Global Cancer Trial Database for Radiation Therapy and Chemotherapy in Treating Patients With Hodgkin's Disease

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Trial Identification

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

Official Title: A Phase III Study of Radiotherapy or ABVD Plus Radiotherapy Versus ABVD Alone in the Treatment of Early Stage Hodgkin's Disease

Study ID: NCT00002561

Study Description

Brief Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high energy x-rays to damage tumor cells. Combining more than one drug or combining chemotherapy with radiation therapy may kill more tumor cells. PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy, with or without chemotherapy, with chemotherapy alone in treating patients with stage I or stage IIA Hodgkin's disease.

Detailed Description: 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. V. Compare the quality of life of patients in patients treated with these regimens. OUTLINE: This is a randomized, multicenter study. Patients are stratified by center. Patients who are under age 40 and have lymphocyte-predominant or nodular sclerosing histology, an erythrocyte sedimentation rate less than 50, and fewer than 4 disease sites (supradiaphragmatic or pelvic node sites) are assigned to cohort 1 (good prognosis). All other patients are assigned to cohort 2 (poor prognosis). Cohort 1: Arm I: Patients with supradiaphragmatic disease undergo radiotherapy to the supradiaphragmatic lymph node areas (mantle region), spleen, and para-aortic lymph nodes 5 days a week for 4 weeks. Patients with pelvic disease undergo radiotherapy to an "inverted-Y" field (excluding the spleen) 5 days a week for 4 weeks. Arm II: Patients receive doxorubicin, bleomycin, vinblastine, and dacarbazine IV on days 1 and 15 (ABVD). Treatment continues every 4 weeks for a total of 2 courses in the absence of disease progression or unacceptable toxicity. Patients with complete remission (CR) after course 2 receive 2 additional courses past CR. Patients with partial remission (PR) after course 2 receive 4 additional courses past PR. Patients with unconfirmed/uncertain complete remission (CRu) receive 2-4 additional courses past CRu. Cohort 2: Arm III: Patients receive ABVD as in arm II, followed 4-6 weeks later by concurrent radiotherapy to the mantle region and upper abdomen to the level of L2 5 days a week for 4 weeks. Alternatively, radiotherapy may also be administered sequentially to the mantle region 5 days a week for 4 weeks and then to the upper abdomen to the level of L2 5 days a week for 4 weeks. Arm IV: Patients receive ABVD only as in arm II. Patients with disease progression after treatment in arms II or IV are considered for radiotherapy. Quality of life is assessed on day 1 of each course of chemotherapy (arms II-IV) and on day 28 of the last course of chemotherapy (arms II and IV); on the first and final days of radiotherapy (arms I and III); at 4 weeks and at 3, 6, and 12 months after completion of radiotherapy (arms I and III) or chemotherapy (arms II and IV); and then annually for 2-10 years. Patients are followed at months 3, 6, and 12 and then annually thereafter. PROJECTED ACCRUAL: A total of 450 patients will be accrued for this study within 7.5 years.

Eligibility

Minimum Age: 16 Years

Eligible Ages: CHILD, ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Tom Baker Cancer Centre, Calgary, Alberta, Canada

Cross Cancer Institute, Edmonton, Alberta, Canada

BCCA - Vancouver Island Cancer Centre, Victoria, British Columbia, Canada

The Vitalite Health Network - Dr. Leon Richard, Moncton, New Brunswick, Canada

Regional Health Authority B, Zone 2, Saint John, New Brunswick, Canada

Dr. H. Bliss Murphy Cancer Centre, St. John's, Newfoundland and Labrador, Canada

QEII Health Sciences Centre, Halifax, Nova Scotia, Canada

Juravinski Cancer Centre at Hamilton Health Sciences, Hamilton, Ontario, Canada

Trillium Health Partners - Credit Valley Hospital, Mississauga, Ontario, Canada

Stronach Regional Health Centre at Southlake, Newmarket, Ontario, Canada

Lakeridge Health Oshawa, Oshawa, Ontario, Canada

Algoma District Cancer Program, Sault Ste. Marie, Ontario, Canada

Health Sciences North, Sudbury, Ontario, Canada

Humber River Hospital, Toronto, Ontario, Canada

Sinai Health System, Toronto, Ontario, Canada

University Health Network, Toronto, Ontario, Canada

CIUSSS de l'Est-de-I'lle-de-Montreal, Montreal, Quebec, Canada

Allan Blair Cancer Centre, Regina, Saskatchewan, Canada

Saskatoon Cancer Centre, Saskatoon, Saskatchewan, Canada

Instituto del Radio O. Alberti Spedali Civili, Brescia, , Italy

Policlinico Monteluce/Univ. Degli Studi Di Perugia, Perugia, , Italy

Royal South Hants Hospital, Southampton, , United Kingdom

Contact Details

Name: Ralph M. Meyer, MD, FRCPC

Affiliation: Margaret and Charles Juravinski Cancer Centre

Role: STUDY_CHAIR

Name: Jane N. Winter, MD

Affiliation: Robert H. Lurie Cancer Center

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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