Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomised Phase III Trial to Determine the Role of FDG-PET Imaging in Clinical Stages IA/IIA Hodgkin's Disease
Brief Summary: RATIONALE: A PET scan may help doctors learn how the cancer responded to combination chemotherapy and whether radiation therapy is also required.

PURPOSE: This randomized phase III trial is studying giving a PET scan to see how well it works in deciding whether patients who have received combination chemotherapy for stage IA or stage IIA Hodgkin lymphoma also need radiation therapy.


Options:
A: 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
B: 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
C: DISEASE CHARACTERISTICS:

* Histologically confirmed Hodgkin's lymphoma

  * No nodular lymphocyte-predominant subtype (nodular paragranuloma)
* Supradiaphragmatic Ann Arbor clinical stage I or II disease
* Must meet criteria for 1 of the following prognostic subsets:

  * Unfavorable subset, defined as meeting 1 of the following criteria:

    * Clinical stage II disease with ≥ 4 nodal areas involved

      * Mediastinum and hili are considered as 1 nodal area
    * Age ≥ 50 years
    * Erythrocyte sedimentation rate (ESR) ≥ 50 mm/hr with no B symptoms
    * ESR ≥ 30 mm/hr with B symptoms
    * Mediastinum/thoracic (MT) ratio ≥ 0.35
  * Favorable subset, defined as meeting all of the following criteria:

    * Clinical stage I disease OR stage II disease with ≤ 3 involved areas
    * Age \< 50 years
    * ESR \< 50 mm/hr (no B symptoms) OR ESR \< 30 mm/hr (B symptoms present)
    * MT ratio \< 0.35
* Previously untreated disease
* Planning to undergo fludeoxyglucose F 18 positron emission tomography after the first 2 courses of study chemotherapy

PATIENT CHARACTERISTICS:

* WHO performance status 0-3
* Bilirubin ≤ 2.5 times upper limit of normal (ULN)
* Creatinine ≤ 2.5 times ULN
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No severe cardiac, pulmonary, neurologic, psychiatric, or metabolic disease
* No unstable diabetes mellitus
* No other malignancies within the past 5 years except for basal cell skin cancer or adequately treated carcinoma in situ of the cervix
* No known HIV infection
* No psychological, familial, sociological, or geographical condition that would preclude study compliance

PRIOR CONCURRENT THERAPY:

* Not specified
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