Please select the eligibility criteria that correspond to the clinical trial below.
Title: Prospective Randomized Comparison of ABVD Versus BEACOPP Chemotherapy With or Without Radiotherapy for Advanced Stage or Unfavorable Hodgkin's Lymphoma (HL)
Brief Summary: The choice of a preferred first-line treatment requires balancing the desire for optimal disease control with the occurrence of early and late treatment-related effects. To fully assess this balance, the treatment decision process should ideally take into account the outcome following a consistent second-line therapy, in particular when tolerated, widely applicable and highly effective salvage regimens exist, like in Hodgkin lymphoma failing initial chemotherapy.


Options:
A: 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
B: Inclusion Criteria:

* Hodgkin Lymphoma (histologically proven)
* CS (PS) IIB with one or both of the risk factors:

  * bulky mediastinal mass (\> 1/3 of maximum transverse thorax diameter)
  * extranodal involvement
* CS (PS) III, IV
* Written informed consent

Exclusion Criteria:

* Leucocytes \< 3000/µl
* Platelets \< 100000/µl
* Hodgkin´s lymphoma as "composite lymphoma"
* Activity index (WHO) \< grade 2
C: Inclusion Criteria:

* Hodgkin´s lymphoma (histologically proven)
* CS (PS) IA, IB, IIA, with one of the risk factors a-d CS (PS) IIB only with risk factor c or d

  1. bulky mediastinal mass (\> 1/3 maximum transverse thorax diameter)
  2. extranodal involvement
  3. ESR \> 50 (A), \> 30 (B-symptoms)
  4. 3 or more lymph node areas involved
* written informaed consent

Exclusion Criteria:

* Leukocytes \<3000/microl
* Platelets \<100000/microl
* Hodgkin´s Disease as "composite lymphoma"
* Activity index (WHO) \< grade 2
D: DISEASE CHARACTERISTICS:

* Histologically confirmed classical Hodgkin lymphoma (HL) meeting the following criteria:

  * Meets current WHO classification criteria (i.e., nodular sclerosis, mixed cellularity, lymphocyte rich, and lymphocyte-depleted)
  * Clinical stage IIB, III, or IV disease OR clinical stage IIA disease with adverse features, including any of the following:

    * Bulk mediastinal disease, defined as maximal transverse diameter of mass \> 0.33 of the internal thoracic diameter at D5/6 interspace on routine chest x-ray
    * Disease outside the mediastinum and lymph node or lymph node mass \> 10 cm in diameter
    * More than two sites of disease
    * Other poor-risk features that require treatment with full course combination chemotherapy
* Newly diagnosed disease
* No CNS or meningeal involvement by lymphoma

PATIENT CHARACTERISTICS:

* ECOG performance status 0-3
* Life expectancy \> 3 months
* ANC \> 1,500/mm\^3 (unless there is bone marrow infiltration by lymphoma)
* Platelet count \> 100,000/mm\^3 (unless there is bone marrow infiltration by lymphoma)
* Creatinine \< 150% of upper limit of normal (ULN)
* Bilirubin \< 2.0 times ULN (unless attributed to lymphoma)
* Transaminases \< 2.5 times ULN (unless attributed to lymphoma)
* LVEF ≥ 50% (in patients with a significant history of ischemic heart disease or hypertension)
* Diffusion capacity within 25% of normal predicted value by lung function testing
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* Amenable to the administration of a full course of chemotherapy, according to the investigator
* Must have access to PET/CT scanning
* No poorly controlled diabetes mellitus
* No cardiac contraindication to doxorubicin hydrochloride, including abnormal contractility by ECHO or MUGA
* No neurological contraindication to chemotherapy (e.g., pre-existing neuropathy)
* No other concurrent uncontrolled medical condition
* No other active malignant disease within the past 10 years, except fully excised basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the uterine cervix
* No known positivity for HIV, hepatitis B surface antigen, or hepatitis C

  * Routine testing, in the absence of risk factors, is not required
* No medical or psychiatric condition that compromises the patient's ability to give informed consent

PRIOR CONCURRENT THERAPY:

* No prior chemotherapy, radiotherapy or other investigational drug for HL

Answer: A