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

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
Study Start Date :	May 2013
Estimated Primary Completion Date :	March 2020
Estimated Study Completion Date :	March 2022

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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Locations

Denmark
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

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 ( EudraCT Number )
First Posted:	July 30, 2012
Last Update Posted:	June 16, 2014
Last Verified:	June 2014

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

advanced stage

Additional relevant MeSH terms:

Lymphoma; Hodgkin Disease; Neoplasms by Histologic Type; Neoplasms	Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases