Please select the eligibility criteria that correspond to the clinical trial below.
Title: Early Salvage With High Dose Chemotherapy and Stem Cell Transplantation in Advanced Stage Hodgkin's Lymphoma Patients With Positive PET After Two Courses of ABVD (PET-2 Positive) and Comparison of RT Versus no RT in PET-2 Negative Patients
Brief Summary: The purpose of this study is to define an improvement in patients:

* To evaluate if patients resistant to the initial treatment for residual PET-positive masses after the first two courses of ABVD (PET-2 positive), can be salvaged by early shift to high-dose chemotherapy supported by stem cell rescue
* To analyse if patients achieving early complete response (PET-2 negative), can be spared the adjuvant radiotherapy on areas of initial bulky disease, at the end of the planned six courses of ABVD. To answer this question, PET-2 negative patients will be randomized between radiotherapy versus no radiotherapy at the end of ABVD therapy.


Options:
A: DISEASE CHARACTERISTICS:

* Histologically confirmed\* Hodgkin lymphoma

  * Clinical stage IA, IB, IIA, or IIB disease according to the modified Ann Arbor Staging Classification system
  * Subclassified according to the WHO modification of the Rye Classification
  * "E" extension allowed provided all other criteria have been met NOTE: \*Pathology materials must be submitted within 60 days of study registration. Core-needle biopsies are acceptable provided they contain adequate tissue for primary diagnosis and immunophenotyping. Fine-needle aspirates not allowed. If multiple specimens are available, submit the most recent.
* No nodular lymphocyte-predominant Hodgkin lymphoma
* No mediastinal mass \> 0.33 maximum intrathoracic diameter by standing postero-anterior chest x-ray or peripheral or retroperitoneal adenopathy \> 10 cm in its largest diameter
* Measurable disease by physical examination or imaging studies

  * Any tumor mass measurable in two dimensions and \> 1 cm (or 1.5 cm if 0.5 cm slices are used, as in spiral CT scans) allowed
  * Lesions that are considered intrinsically non-measurable include:

    * Bone lesions
    * Leptomeningeal disease
    * Ascites
    * Pleural/pericardial effusion
    * Lymphangitis cutis/pulmonis
    * Abdominal masses that are not confirmed and followed by imaging techniques
    * Cystic lesions
    * Lesions that are situated in a previously irradiated area

PATIENT CHARACTERISTICS:

* Performance status 0-2
* ANC ≥ 1,000/μL
* Platelet count ≥ 100,000/μL
* Serum creatinine ≤ 2 mg/dL
* Bilirubin ≤ 2 mg/dL
* AST ≤ 2 times upper limit of normal
* LVEF normal by ECHO or MUGA
* DLCO ≥ 60% with no symptomatic pulmonary disease
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* Patients with known HIV allowed provided they have CD4 counts ≥ 350/mcL

  * Patients must not have multi-drug resistant HIV infections (i.e., concurrent AIDS-defining conditions)
  * An HIV test is required for patients with a history of IV drug abuse or any behavior associated with an increased risk of HIVinfection
* No "currently active" second malignancy other than nonmelanoma skin cancers

  * Patients are not considered to have a "currently active" malignancy provided they have completed therapy and are considered by their physician to be at \< 30% risk of relapse

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* No prior chemotherapy or radiotherapy for Hodgkin lymphoma

  * 1 course of ABVD (doxorubicin, bleomycin, vinblastine, and dacarbazine) allowed and will be considered the first course
B: DISEASE CHARACTERISTICS:

* Histologically confirmed Hodgkin Lymphoma

  * Stage IA or IIA disease

    * No stage IA Hodgkin lymphoma with no clinical or CT evidence of disease after diagnostic biopsy
  * Above the diaphragm with no mediastinal bulk, defined as maximum transverse diameter of mediastinal mass

    * Internal thoracic diameter at level of D5/6 interspace \> 0.33
  * Bulky disease at other sites, defined as nodal mass with transverse diameter ≥ 10 cm allowed

PATIENT CHARACTERISTICS:

* Not pregnant or nursing
* Fertile patients must use effective contraception during and for ≥ 6 months
* No prior malignancy except appropriately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix
* No severe underlying illness considered to make the trial therapy hazardous (i.e., severe heart disease or lung fibrosis)
* Willing to travel to the nearest PET scan center
* Able to comply with protocol follow-up arrangements

PRIOR CONCURRENT THERAPY:

* No prior treatment for Hodgkin lymphoma
* No contraindications to chemotherapy or radiotherapy
C: Inclusion Criteria:

* Patients with advanced classical Hodgkin Lymphoma according to the World Health Organization classification
* Aged 18-60
* Not previously treated
* Stages IIB to IV B
* All IPS prognostic groups
* Patients who have signed an informed consent form

Exclusion Criteria:

* Patients aged more than 60.
* Concomitant or previously treated neoplastic disorder less than 5 year before the diagnosis of Hodgkin's lymphoma.
* Psychiatric disorders
* Uncontrolled infectious disease
* Impaired cardiac (EF \< 50%) , renal (creatinine clearance \< 60 ml/m)
* HIV, HBV DNA, HCV RNA positive markers
* Pregnancy and lactation
* Patients with uncompensated diabetes mellitus and fasting glucose levels over 200 mg/dl
D: Inclusion Criteria:

* Histologically confirmed Hodgkin's lymphoma of the classical type (nodular lymphocyte predominance excluded).
* Stage IIB-IV.
* Age 18-70.
* No prior therapy for Hodgkin's lymphoma
* Written informed consent.
* ECOG performance status grades 0-3 (see Appendix E).
* FDG-PET scan before the initiation of treatment.

Exclusion Criteria:

* Prior therapy for Hodgkin's lymphoma.
* Age less than 18 or more than 70.
* Other concomitant or prior malignancies, except basal cell skin carcinoma, or adequately treated carcinoma in situ of the cervix, or any cancer in complete remission for more than 5 years.
* HIV infection.
* Pregnancy or breast-feeding.
* Renal failure (creatinine ≥2 times the normal value), liver failure (AST/ALT or bilirubine ≥ 2.5 times the normal value) or heart failure (NYHA class ≥ 2 or FEV \< 45%).

Answer: D