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

This study is currently recruiting participants.
Verified June 2013 by European Organisation for Research and Treatment of Cancer - EORTC
Sponsor:
Collaborator:
Polish Lymphoma Research Group
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier:
NCT01652261
First received: July 18, 2012
Last updated: June 18, 2013
Last verified: June 2013
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by European Organisation for Research and Treatment of Cancer - EORTC:

Primary Outcome Measures:
  • Freedom from treatment failure [ Time Frame: 9 years after first patient in (FPI) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • response at the end of therapy [ Time Frame: 9 years after FPI ] [ Designated as safety issue: No ]
  • Progression-free survival [ Time Frame: 9 years after FPI ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: 9 years after FPI ] [ Designated as safety issue: No ]
  • Acute toxicity [ Time Frame: 9 years after FPI ] [ Designated as safety issue: Yes ]
    • 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 [ Time Frame: 9 years after FPI ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 570
Study Start Date: May 2013
Estimated Study Completion Date: March 2022
Estimated Primary Completion Date: March 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01652261

Contacts
Contact: Alice Preumont +32 2 774 15 10 alice.preumont@eortc.be

Locations
Denmark
Rigshospitalet Recruiting
Copenhagen, Denmark, 2100
Contact: Martin Hutchings, MD         
Principal Investigator: Martin Hutchings, MD         
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 Centre Groningen
Study Chair: Wim Oyen Radboud University
  More Information

No publications provided

Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier: NCT01652261     History of Changes
Other Study ID Numbers: EORTC-20101-23101, 2011-005473-22
Study First Received: July 18, 2012
Last Updated: June 18, 2013
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
advanced stage

Additional relevant MeSH terms:
Hodgkin Disease
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on April 21, 2014