Status:
COMPLETED
Fludeoxyglucose F 18-PET/CT Imaging in Assessing Response to Chemotherapy in Patients With Newly Diagnosed Stage II, Stage III, or Stage IV Hodgkin Lymphoma
Lead Sponsor:
University College, London
Collaborating Sponsors:
Cancer Research UK
Cancer Research UK & UCL Cancer Trials Centre
Conditions:
Lymphoma
Eligibility:
All Genders
18-100 years
Phase:
PHASE3
Brief Summary
RATIONALE: Imaging procedures, such as fludeoxyglucose F 18 (FDG)-PET/CT scan, done before, during, and after chemotherapy may help doctors assess a patient's response to treatment and help plan the b...
Detailed Description
OBJECTIVES: * To determine if fludeoxyglucose F 18 (FDG)-PET/CT imaging can be reproducibly and effectively applied in the early assessment of response to chemotherapy in patients with newly diagnose...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
August 29 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2024
Estimated Enrollment :
1202 Patients enrolled
Trial Details
Trial ID
NCT00678327
Start Date
August 29 2008
End Date
May 1 2024
Last Update
May 8 2024
Active Locations (1)
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1
Southampton General Hospital
Southampton, England, United Kingdom, SO16 6YD