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 | Recruiting
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

Trial Source

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Health Conditions
  • Lymphoma
Unfortunately contact details are not available for this trial.
Primary Contact Details
Recruiting
Recruitment Status
NCT00678327
Primary Trial ID Number
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 best treatment. It is not yet known whether FDG-PET/CT imaging is effective in assessing response to chemotherapy in patients with newly diagnosed Hodgkin lymphoma. PURPOSE: This randomized phase III trial is studying FDG-PET/CT imaging to see how well it works in assessing response to chemotherapy in patients with newly diagnosed stage II, stage III, or stage IV Hodgkin lymphoma.
Research Details
  • 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 diagnosed stage II-IV Hodgkin lymphoma. - To determine if a negative FDG-PET/CT scan after 2 courses of ABVD chemotherapy comprising doxorubicin hydrochloride, bleomycin, vinblastine, and dacarbazine can be used to predict a group of patients for whom it is safe to reduce therapy by the subsequent omission of bleomycin, without detriment to progression-free survival. - To determine if treatment intensification in response to positive FDG-PET/CT imaging after 2 courses of ABVD chemotherapy can improve the outcome by comparison with previous series. OUTLINE: This is a multicenter study. Patients undergo fludeoxyglucose F 18 (FDG)-PET/CT imaging at baseline. Patients then receive ABVD chemotherapy comprising doxorubicin hydrochloride IV, bleomycin IV, vinblastine IV, and dacarbazine IV on days 1 and 15. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity. Between days 22 and 25 of course 2, patients undergo a second FDG-PET/CT scan to assess response. Subsequent therapy is based on FDG-PET/CT scan results. - Negative FDG-PET/CT scan: Patients with a negative FDG-PET/CT scan are randomized to 1 of 2 treatment arms. - Arm I (ABVD chemotherapy): Patients receive ABVD chemotherapy comprising doxorubicin hydrochloride IV, bleomycin IV, vinblastine IV, and dacarbazine IV on days 1 and 15. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. - Arm II (AVD chemotherapy): Patients receive AVD chemotherapy comprising doxorubicin hydrochloride IV, vinblastine IV, and dacarbazine IV on days 1 and 15. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. - Positive FDG-PET/CT scan: Patients with a positive FDG-PET/CT scan are assigned to 1 of 2 chemotherapy regimens, as determined by the participating center. - BEACOPP-14 chemotherapy: Patients receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1; etoposide IV on days 1-3; oral procarbazine hydrochloride and oral prednisolone on days 1-7; and bleomycin IV and vincristine IV on day 8. Patients also receive filgrastim (G-CSF) subcutaneously (SC) on days 8-13 OR pegfilgrastim SC once on day 8. Treatment repeats every 14 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. - BEACOPP-escalated chemotherapy: Patients receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1; etoposide IV on days 1-3; oral procarbazine hydrochloride on days 1-7; oral prednisolone on days 1-14; and bleomycin IV and vincristine IV on day 8. Patients also receive G-CSF SC beginning on day 8 and continuing until blood counts recover OR pegfilgrastim SC once on day 8. Treatment repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. After completion of BEACOPP chemotherapy, patients undergo a third FDG-PET/CT scan to assess response. Patients with a negative FDG-PET/CT scan receive 2 more courses of BEACOPP-14 or 1 more course of BEACOPP-escalated chemotherapy. Patients with a persistently positive FDG-PET/CT scan may receive radiotherapy to sites of FDG uptake or salvage chemotherapy, at the investigator's discretion. After completion of study therapy, patients are followed every 3 months for 1 year, every 4 months for 2 years, every 6 months for 2 years, and then annually thereafter. Peer Reviewed and Funded or Endorsed by Cancer Research UK.
Phase
Phase 3
Study Design
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Study Type
Interventional
Intervention
Biological : bleomycin sulfate, Biological : filgrastim, Biological : pegfilgrastim, Drug : cyclophosphamide, Drug : dacarbazine, Drug : doxorubicin hydrochloride, Drug : etoposide, Drug : prednisolone, Drug : procarbazine hydrochloride, Drug : vinblastine sulfate, Drug : vincristine sulfate

Study Arm Groups : Arm I, BEACOPP-14 chemotherapy, BEACOPP-escalated chemotherapy, BEACOPP-14 chemotherapy, BEACOPP-escalated chemotherapy, BEACOPP-14 chemotherapy, BEACOPP-escalated chemotherapy, BEACOPP-14 chemotherapy, BEACOPP-escalated chemotherapy, Arm I, Arm II, Arm I, Arm II, BEACOPP-14 chemotherapy, BEACOPP-escalated chemotherapy, BEACOPP-14 chemotherapy, BEACOPP-escalated chemotherapy, BEACOPP-14 chemotherapy, BEACOPP-escalated chemotherapy, BEACOPP-14 chemotherapy, BEACOPP-escalated chemotherapy, Arm I, Arm II, BEACOPP-14 chemotherapy, BEACOPP-escalated chemotherapy

Intervention Type
See Interventions above
Primary Outcome Measures
  • 3-year progression-free survival; null
Secondary Outcome Measures
  • Overall survival; null; Acute and chronic toxicity as assessed by NCI CTCAE v3.0; null
Publication(s)
Sorry, this information is not available
Result Reports
This is available on the Clinicaltrials.gov website
Gender
Both
Age Range
18 Years - N/A
Who Can Participate
Patients
Number of Participants
1200
Participant Inclusion Criteria
  • 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
Participant Exclusion Criteria
This is in the inclusion criteria above
Trial Location(s)
Southampton General Hospital
Southampton
England
SO16 6YD
Trial Contact(s)
Primary Trial Contact
Sorry, this information is not available
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
United Kingdom
Scientific Title
A Randomized Phase III Trial to Assess Response Adapted Therapy Using FDG-PET Imaging in Patients With Newly Diagnosed, Advanced Hodgkin Lymphoma
EudraCT Number
Not available for this trial
Funder(s)
    Sorry, this information is not available
Other Study ID Numbers
CDR0000593562
Sponsor(s)
Cancer Research UK
Key Dates

Recruitment Start Date

Aug 2008

Recruitment End Date

Sep 2012

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date Assigned

09 May 2008

Last Updated

23 Aug 2013