Please select the eligibility criteria that correspond to the clinical trial below.
Title: The H10 EORTC/GELA/IIL Randomized Intergroup Trial on Early FDG-PET Scan Guided Treatment Adaptation Versus Standard Combined Modality Treatment in Patients With Supradiaphragmatic Stage I/II Hodgkin's Lymphoma
Brief Summary: RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. Diagnostic procedures, such as fludeoxyglucose F 18 positron emission tomography (FDG-PET scan), may help doctors predict a patient's response to treatment and help plan the best treatment. It is not yet known whether FDG-PET scan-guided therapy is more effective than standard therapy in treating Hodgkin's lymphoma.

PURPOSE: This randomized phase III trial is studying FDG-PET scan-guided therapy to see how well it works compared with standard therapy in treating patients with previously untreated stage I or stage II Hodgkin's lymphoma.


Options:
A: Inclusion criteria:

* Histologically proven previously untreated classical Hodgkin's lymphoma
* The following stages are eligible:

  * Locally extensive: Stage I-IIA/B with massive mediastinal adenopathy
  * Advanced: Stage III or IV
* Measurable or evaluable disease
* Age of 16 and over
* ECOG Performance status 0-2
* Disease-free of prior invasive malignancies for \>5 years with the exception of curatively-treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix
* White blood cell (WBC) at least 4,000/mm³, (unless documented bone marrow involvement)
* Platelet count at least 100,000/mm³ (unless documented bone marrow involvement)
* Bilirubin no greater than 5.0 mg/dL
* Creatinine no greater than 2.0 mg/dL
* Ejection fraction determination recommended if over age 50 and/or have a history of cardiac disease
* Fertile patients must use effective contraception
* Prior corticosteroids allowed
* Prior surgery allowed

Exclusion criteria:

* Pregnant or nursing
* Prior radiotherapy
* Prior chemotherapy
* Human immunodeficiency virus (HIV) positive
B: 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
C: DISEASE CHARACTERISTICS:

* Histologically confirmed supradiaphragmatic Hodgkin's lymphoma

  * Stage I or II disease
* Previously untreated disease

PATIENT CHARACTERISTICS:

* WHO performance status 0-2
* Normal life expectancy
* No severe cardiac, pulmonary, neurologic, or metabolic disease that would interfere with normal life expectancy or study treatment
* No other prior or concurrent malignancy except basal cell skin cancer or carcinoma in situ of the cervix
* No psychological, familial, socioeconomic, or geographic circumstance that would preclude proper staging or study compliance
* HIV negative
* Not pregnant
* Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

* No prior staging laparotomy
* No prior biologic therapy, chemotherapy, endocrine therapy, radiotherapy, or surgery for this malignancy
D: Inclusion Criteria:

* Histologically confirmed, newly diagnosed Hodgkin's lymphoma (pathological review diagnosis available)
* No prior treatment
* Stage II B, III A and B, IV A and B
* Normal hematopoietic function as measured by leucocytes equal to or greater than 3500/mm3, neutrophils equal to or greater than 1500/mm3, platelets equal to or greater than 100000/mm3
* Normal renal function (serum creatinine \< 1,5x ULN) and normal liver function (SGOT/SGPT equal to or lower than 2.5x ULN; bilirubin equal to or lower than 1.5x ULN)
* No significant history or current evidence of cardiovascular disease, or major respiratory disease
* No severe neurologic or psychiatric disease
* No other malignancy except basal cell carcinoma of the skin and/or in situ cervical carcinoma of the uterus
* Serological negativity for hepatitis B or C or HIV infection
* ECOG performance status equal to or lower than 2
* Life expectancy of at least three months
* Effective contraception in all patients and a negative pregnancy test for women of childbearing potential
* Written informed consent and consent to a regular follow-up in the outpatient clinic

Exclusion criteria:

* Sever central nervous system or psychiatric disease
* History or current evidence of clinically significant cardiac disease (congestive heart failure, uncontrolled hypertension, unstable coronary artery disease or myocardial infarction or severe arrhythmias. Left ventricular ejection fraction \< 50% at rest by echocardiography or \< 55% by isotopic measurement
* Serological positivity for HBV, HCV or HIV
* History or current evidence of malignancy other than basal cell carcinoma of the skin, carcinoma in situ of the cervix
* Lactating or pregnant women

Answer: B