Clinical trial NCT01652261: Very Early FDG-PET/CT-response Adapted Therapy for Advanced Hodgkin Lymphoma (H11)
Official title: Very Early FDG-PET/CT-response Adapted Therapy for Advanced Stage Hodgkin Lymphoma, a Randomized Phase III Non-inferiority Study of the EORTC Lymphoma Group
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Hodgkin Lymphoma
Keywords: advanced stage
Lead sponsor: European Organisation for Research and Treatment of Cancer - EORTC
Sponsor class: NETWORK
Collaborators: name: Polish Lymphoma Research Group
First posted: 2012-07-30
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main objective of the trial is to show that doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD)-based response-adapted therapy for advanced-stage Hodgkin lymphoma, with treatment intensification (bleomycin, etoposide, adriamycin, cyclophosphamide, vincristine, procarbazine, and prednisone (BEACOPPesc) in case of a positive fluorodeoxyglucose (FDG) positron emission tomography (PET) computed tomography (CT) after one cycle of ABVD, has non-inferior efficacy compared with the intensive BEACOPPesc regimen. A second objective is to assess the prognostic value of FDG-PET/CT after one cycle of BEACOPPesc.


Eligibility criteria: Inclusion criteria:

* Previously untreated, histologically proven classical Hodgkin lymphoma
* Clinical stages III/IV (Ann Arbor)
* Age 18-60
* WHO performance 0-2
* Adequate organ function
* Patients of childbearing/reproductive potential should use adequate birth control measures during the whole duration of study treatment.
* Written informed consent according to ICH/EU Good Clinical Practice, and national/local regulations

Exclusion criteria:

* Pregnancy or lactation
* Specific contraindications to BEACOPPesc therapy, including:
* Poorly controlled diabetes mellitus
* HIV infection,
* Chronic active hepatitis B and/or hepatitis C
* Concomitant or previous malignancies with the exception of basal cell skin tumors, adequately treated carcinoma in situ of the cervix and any cancer that has been in complete remission for \>5 years
* Psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial

Primary outcomes:
measure: Freedom from treatment failure
timeFrame: 9 years after first patient in (FPI)
Secondary outcomes:
measure: response at the end of therapy
timeFrame: 9 years after FPI
measure: Progression-free survival
timeFrame: 9 years after FPI
measure: Overall survival
timeFrame: 9 years after FPI
measure: Acute toxicity
timeFrame: 9 years after FPI
measure: Long-term toxicity in terms of second malignancies, cardiovascular and pulmonary events
timeFrame: 9 years after FPI
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
Study officials:
affiliation: Rigshospitalet, Denmark
name: Martin Hutchings
role: STUDY_CHAIR
affiliation: The Netherlands Cancer Institute, Amsterdam, The Netherlands
name: Berthe Aleman
role: STUDY_CHAIR
affiliation: University Medical Center Groningen
name: Gustaaf van IMHOFF
role: STUDY_CHAIR
affiliation: Radboud University Medical Center
name: Wim Oyen
role: STUDY_CHAIR
References: