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Very Early FDG-PET/CT-response Adapted Therapy for Advanced Hodgkin Lymphoma (H11) (H11)

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ClinicalTrials.gov Identifier: NCT01652261
Recruitment Status : Withdrawn (Study closed due to lack of recruitment)
First Posted : July 30, 2012
Last Update Posted : February 15, 2021
Sponsor:
Collaborator:
Polish Lymphoma Research Group
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC

Study Description
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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
Hodgkin Lymphoma Drug: ABVD + FDG-PET/CT Scan treatment adaptation Drug: BEACOPPesc Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : May 2013
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

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Arms and Interventions
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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
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Primary Outcome Measures :
  1. Freedom from treatment failure [ Time Frame: 9 years after first patient in (FPI) ]

Secondary Outcome Measures :
  1. response at the end of therapy [ Time Frame: 9 years after FPI ]
  2. Progression-free survival [ Time Frame: 9 years after FPI ]
  3. Overall survival [ Time Frame: 9 years after FPI ]
  4. Acute toxicity [ Time Frame: 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.

  5. Long-term toxicity in terms of second malignancies, cardiovascular and pulmonary events [ Time Frame: 9 years after FPI ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01652261


Locations
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Denmark
Rigshospitalet
Copenhagen, Denmark, 2100
Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
Polish Lymphoma Research Group
Investigators
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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
More Information
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Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier: NCT01652261    
Other Study ID Numbers: EORTC-20101-23101
2011-005473-22 ( EudraCT Number )
First Posted: July 30, 2012    Key Record Dates
Last Update Posted: February 15, 2021
Last Verified: June 2014
Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
advanced stage
Additional relevant MeSH terms:
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Lymphoma
Hodgkin Disease
Neoplasms by Histologic Type
Neoplasms
 Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases