Please select the eligibility criteria that correspond to the clinical trial below.
Title: Protocol H8 for a Prospective Controlled Trial in Clinical Stage I-II Supradiaphragmatic Hodgkin's Disease. Evaluation of Treatment Efficacy and (Long Term) Toxicity in Three Different Prognostic Subgroups [H8 Trial]
Brief Summary: RATIONALE: Radiation therapy uses high-energy x-rays to kill cancer cells. 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 radiation therapy together with combination chemotherapy may kill more cancer cells. It is not yet known whether radiation therapy is more effective with or without combination chemotherapy in treating patients with Hodgkin's lymphoma.

PURPOSE: This randomized phase III trial is studying radiation therapy to see how well it works with or without combination chemotherapy in treating patients with previously untreated stage I or stage II Hodgkin's lymphoma.


Options:
A: 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
B: 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
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 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

Answer: A