Please select the eligibility criteria that correspond to the clinical trial below.
Title: Phase II Trial of Response-Adapted Chemotherapy Based on Positron Emission Tomography for Non-Bulky Stage I and II Hodgkin Lymphoma
Brief Summary: This phase II trial studies how well chemotherapy based on positron emission tomography (PET) scan works in treating patients with stage I or stage II Hodgkin lymphoma. 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. Radiation therapy uses high energy x-rays to kill cancer cells. Giving combination chemotherapy together with radiation therapy may kill more cancer cells and allow doctors to save the part of the body where the cancer started. Comparing results of diagnostic procedures, such as PET scan, done before, during, and after chemotherapy may help doctors predict a patient's response to treatment and help plan the best treatment.


Options:
A: Inclusion Criteria:

* Patient with a first diagnosis of classical Hodgkin lymphoma according to world health organization (WHO) criteria excluding nodular lymphocyte predominant subtype
* Age of 16 to 60 years
* No previous treatment for Hodgkin lymphoma
* Ann Arbor stages:

IIB with mediastinum/thorax ≥0.33 or extra nodal localization III IV

* Baseline 18-FDG PET scan (PET0)(F-FDG Positon Emission Tomography) performed before any treatment with at least one hypermetabolic lesion
* Eastern Cooperative Oncology Group (ECOG) performance status \< 3
* With a minimum life expectancy of 3 months
* Having previously signed a written informed consent
* The patient must be covered by a social security system (in France)

Exclusion Criteria:

* Pregnant or lactating women
* Men and women of childbearing potential not practicing an adequate method of contraception during the study treatment and at least 3 months after the last study drug administration
* Any history of cancer or cancer treatment during the last 5 years with the exception of non-melanoma skin tumors or stage 0 (in situ) cervical carcinoma
* Uncontrolled infectious disease, including active HBV (hepatitis B virus) infection defined by either detection of HBs Antigen or presence of anti HBs antibody without detectable anti HBc antibody.
* HIV (Human immunodeficiency virus), HCV (hepatitis C virus) or HTLV (Human T-lymphotropic virus) serology positivity
* Abnormal liver (bilirubin \> 2,5 N) function unless abnormalities are due to AHL 2011 Protocol Version n°1.2_ 09/02/11_approved on March 11, 2011 EudraCT n°2010-022844-19 4 / 73 Hodgkin lymphoma
* Abnormal renal (Creatinin \> 150 μmol/L) function unless abnormalities are due to Hodgkin lymphoma
* Leukopenia \< 2 G/l or thrombopenia \<100 G/l unless abnormalities are due to Hodgkin lymphoma
* Severe cardio-pulmonary, or metabolic disease interfering with normal application of protocol treatment:
* Left Ejection Ventricular Fraction \<50%
* Respiratory insufficiency prohibiting bleomycin use
* Uncontrolled diabetes mellitus leading to impossibility to perform PET scan
* Impossibility to perform a baseline PET (PET0) before randomization and treatment beginning
* Incapable person
B: 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%).
C: 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
D: 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

Answer: C