Combination Chemotherapy With or Without Radiation Therapy in Treating Patients With Hodgkin's Ly… (NCT00005584) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Combination Chemotherapy With or Without Radiation Therapy in Treating Patients With Hodgkin's Lymphoma
Belgium1,649 participantsStarted 1998-10
Plain-language summary
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer cells. Combining chemotherapy with radiation therapy may kill more cancer cells. It is not yet known which combination chemotherapy regimen is most effective in treating Hodgkin's lymphoma.
PURPOSE: Randomized phase III trial to compare the effectiveness of different regimens of combination chemotherapy with or without radiation therapy in treating patients who have Hodgkin's lymphoma.
Who can participate
Age range15 Years – 70 Years
SexALL
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DISEASE CHARACTERISTICS:
* Randomized groups: Histologically proven previously untreated stage I or II supradiaphragmatic Hodgkin's lymphoma
* No prior staging laparotomy
* Favorable (closed to accrual as of 4/28/04) or unfavorable (closed to accrual as of 9/2002) prognosis
* Nonrandomized group: Histologically proven lymphocyte-predominant Hodgkin's lymphoma, nodular subtype (nodular paragranuloma)
* Stage I with complete or incomplete resection OR
* Stage II
PATIENT CHARACTERISTICS:
Age:
* 15 to 70
Performance status:
* WHO 0-2
Life expectancy:
* Not specified
Hematopoietic:
* Not specified
Hepatic:
* Not specified
Renal:
* Not specified
Cardiovascular:
* No severe cardiac disease that would interfere with normal life expectancy or study treatment
Pulmonary:
* No severe pulmonary disease that would interfere with normal life expectancy or study treatment
Other:
* No other prior or concurrent malignancy except basal cell skin cancer or carcinoma in situ of the cervix
* No severe neurologic or metabolic disease that would interfere with normal life expectancy or study treatment
* No psychologic, familial, socioeconomic, or geographic circumstances that would preclude proper staging or compliance
* HIV negative
* Not pregnant
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy
* No prior biologic therapy for this malignancy
Chemotherapy
* No prior chemotherapy for this malignancy
Endocrine therapy
…
What they're measuring
1
Relapse-free rate
Timeframe: 5 years
Trial details
NCT IDNCT00005584
SponsorEuropean Organisation for Research and Treatment of Cancer - EORTC