Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:54 AM
Ignite Modification Date:
2025-12-25 @ 2:54 AM
NCT ID:
NCT00433433
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed Hodgkin's lymphoma
* No nodular lymphocyte-predominant subtype (nodular paragranuloma)
* Supradiaphragmatic Ann Arbor clinical stage I or II disease
* Must meet criteria for 1 of the following prognostic subsets:
* Unfavorable subset, defined as meeting 1 of the following criteria:
* Clinical stage II disease with ≥ 4 nodal areas involved
* Mediastinum and hili are considered as 1 nodal area
* Age ≥ 50 years
* Erythrocyte sedimentation rate (ESR) ≥ 50 mm/hr with no B symptoms
* ESR ≥ 30 mm/hr with B symptoms
* Mediastinum/thoracic (MT) ratio ≥ 0.35
* Favorable subset, defined as meeting all of the following criteria:
* Clinical stage I disease OR stage II disease with ≤ 3 involved areas
* Age \< 50 years
* ESR \< 50 mm/hr (no B symptoms) OR ESR \< 30 mm/hr (B symptoms present)
* MT ratio \< 0.35
* Previously untreated disease
* Planning to undergo fludeoxyglucose F 18 positron emission tomography after the first 2 courses of study chemotherapy
PATIENT CHARACTERISTICS:
* WHO performance status 0-3
* Bilirubin ≤ 2.5 times upper limit of normal (ULN)
* Creatinine ≤ 2.5 times ULN
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No severe cardiac, pulmonary, neurologic, psychiatric, or metabolic disease
* No unstable diabetes mellitus
* No other malignancies within the past 5 years except for basal cell skin cancer or adequately treated carcinoma in situ of the cervix
* No known HIV infection
* No psychological, familial, sociological, or geographical condition that would preclude study compliance
PRIOR CONCURRENT THERAPY:
* Not specified
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
15 Years
Maximum Age:
70 Years
Study:
NCT00433433
Study Brief:
Protocol Section:
NCT00433433