Very Early FDG-PET/CT-response Adapted Therapy for Advanced Hodgkin Lymphoma (H11)
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: experimental arm An experimental arm (early FDG-PET/CT-response adapted), where all patients are initially treated with a single cycle of ABVD. Very early FDG-PET/CT-negative patients continue on ABVD therapy to a total of six cycles. Very early FDG-PET/CT-positive patients receive 3 cycles of BEACOPPesc followed by another 3 cycles of BEACOPPesc. Mid-treatment evaluation is performed after 4 cycles. In case of treatment failure (less than partial remission (PR)), the patient goes off protocol treatment. Only patients with residual FDG-PET/CT-positive disease after chemotherapy will receive radiotherapy (36 Gy/18 fractions on the FDG-PET/CT-positive residual mass(es)). |
Drug: ABVD + FDG-PET/CT Scan treatment adaptation
Drug: BEACOPPesc
|
| Active Comparator: standard arm A standard arm, where patients are treated with four cycles of BEACOPPesc followed by 2 cycles of BEACOPPesc. FDG-PET/CT is performed after one cycle, but with no therapeutic consequences. Mid-treatment evaluation is performed after four cycles. In case of treatment failure (less than PR), the patient goes off protocol treatment. Only patients with residual FDG-PET/CT-positive disease after chemotherapy will receive radiotherapy (36 Gy/18 fractions on the FDG-PET/CT-positive residual mass(es)). |
Drug: BEACOPPesc
|
Outcome Measures
Primary Outcome Measures
- Freedom from treatment failure [9 years after first patient in (FPI)]
Secondary Outcome Measures
- response at the end of therapy [9 years after FPI]
- Progression-free survival [9 years after FPI]
- Overall survival [9 years after FPI]
- Acute toxicity [9 years after FPI]
Hematological toxicity (blood cell count) can be significant especially for patients who will receive BEACOPPesc . Bleomycine interstitial pneumonitis has been frequently reported and requires the immediate stop of further bleomycine administration. Rarely, procarbazine allergy and intolerance has been reported. Nausea & vomiting due to cyclophosphamide, doxorubicin, dacarbazine and procarbazine may be significant. Total reversible alopecia occurs in most cases. Escalated BEACOPP-related toxic deaths have been reported but do not exceed those observed with standard ABVD.
- Long-term toxicity in terms of second malignancies, cardiovascular and pulmonary events [9 years after FPI]
Eligibility Criteria
Criteria
Inclusion criteria:
-
Previously untreated, histologically proven classical Hodgkin lymphoma
-
Clinical stages III/IV (Ann Arbor)
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Age 18-60
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WHO performance 0-2
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Adequate organ function
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Patients of childbearing/reproductive potential should use adequate birth control measures during the whole duration of study treatment.
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Written informed consent according to ICH/EU Good Clinical Practice, and national/local regulations
Exclusion criteria:
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Pregnancy or lactation
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Specific contraindications to BEACOPPesc therapy, including:
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Poorly controlled diabetes mellitus
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HIV infection,
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Chronic active hepatitis B and/or hepatitis C
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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
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Rigshospitalet | Copenhagen | Denmark | 2100 |
Sponsors and Collaborators
- European Organisation for Research and Treatment of Cancer - EORTC
- Polish Lymphoma Research Group
Investigators
- Study Chair: Martin Hutchings, Rigshospitalet, Denmark
- Study Chair: Berthe Aleman, The Netherlands Cancer Institute, Amsterdam, The Netherlands
- Study Chair: Gustaaf van IMHOFF, University Medical Center Groningen
- Study Chair: Wim Oyen, Radboud University Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- EORTC-20101-23101
- 2011-005473-22