Please select the eligibility criteria that correspond to the clinical trial below.
Title: BEACOPP (4 Cycles Escalated + 4 Cycles Baseline) Versus ABVD (8 Cycles) In Stage III & IV Hodgkin's Lymphoma
Brief Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. It is not yet known which combination chemotherapy regimen is more effective in treating stage III or stage IV Hodgkin's lymphoma.

PURPOSE: Randomized phase III trial to compare the effectiveness of two combination chemotherapy regimens in treating patients who have stage III or stage IV Hodgkin's lymphoma.


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: 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
C: DISEASE CHARACTERISTICS:

* Histologically confirmed Hodgkin's lymphoma

  * No lymphocyte predominant, nodular type (nodular paragranuloma)
  * Clinical stage III or IV disease
* At least 1 bidimensionally measurable target lesion or extranodal lesion
* International Prognostic Score of at least 3

PATIENT CHARACTERISTICS:

Age

* 16 to 60

Performance status

* WHO 0-2

Life expectancy

* Not specified

Hematopoietic

* WBC greater than 2,000/mm\^3
* Platelet count greater than 100,000/mm\^3

Hepatic

* No prior uncontrolled hepatitis B viral infection
* Bilirubin no greater than 2.5 times normal (unless due to Hodgkin's lymphoma)

Renal

* Creatinine no greater than 2.0 mg/dL (unless due to Hodgkin's lymphoma)

Cardiovascular

* No severe cardiac disease that would limit normal life expectancy or preclude study
* LVEF at least 50%

Pulmonary

* No severe pulmonary disease that would limit normal life expectancy or preclude study
* Respiratory function at least 30%

Other

* HIV negative
* HTLV1 negative
* No severe active infection
* No severe neurological or metabolic disease that would limit normal life expectancy or preclude study
* No other prior or concurrent malignancy except basal cell skin cancer or carcinoma in situ of the cervix
* No psychological, familial, sociological, or geographical condition that would preclude study
* Not pregnant or nursing
* Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Not specified

Chemotherapy

* Not specified

Endocrine therapy

* Not specified

Radiotherapy

* No concurrent radiotherapy

Surgery

* Not specified

Other

* No prior therapy for Hodgkin's lymphoma
D: 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

Answer: C