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Very Early FDG-PET/CT-response Adapted Therapy for Advanced Hodgkin Lymphoma (H11) (H11)
This study has been withdrawn prior to enrollment.
(Study closed due to lack of recruitment)
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
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 13, 2014
Last verified: June 2014
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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 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 |
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) ]
Secondary Outcome Measures:
- response at the end of therapy [ Time Frame: 9 years after FPI ]
- Progression-free survival [ Time Frame: 9 years after FPI ]
- Overall survival [ Time Frame: 9 years after FPI ]
- 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.
- Long-term toxicity in terms of second malignancies, cardiovascular and pulmonary events [ Time Frame: 9 years after FPI ]
| Enrollment: | 0 |
| 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 (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 Contacts provided below.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01652261
Please refer to this study by its ClinicalTrials.gov identifier: NCT01652261
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
| 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 ) |
| Study First Received: | July 18, 2012 |
| Last Updated: | June 13, 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 |
ClinicalTrials.gov processed this record on September 20, 2017