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

Phase 3

Withdrawn

• Conditions: Hodgkin Lymphoma
• Interventions: Drug: ABVD + FDG-PET/CT Scan treatment adaptation; Drug: BEACOPPesc

• Registration Number: NCT01652261
• Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-07-18
• Study First Submitted QC: 2012-07-27
• Study First Posted: 2012-07-30
• Study Start: 2013-05
• Status Verified: 2014-06
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Last Update Submitted: 2021-02-11
• Last Update Posted: 2021-02-15

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
experimental arm	ABVD + FDG-PET/CT Scan treatment adaptation	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)).
experimental arm	BEACOPPesc	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)).
standard arm	BEACOPPesc	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)).

Primary Outcome Measures

Name	Time	Method
Freedom from treatment failure	9 years after first patient in (FPI)

Secondary Outcome Measures

Name	Time	Method
response at the end of therapy	9 years after FPI
Progression-free survival	9 years after FPI
Long-term toxicity in terms of second malignancies, cardiovascular and pulmonary events	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.
Overall survival	9 years after FPI

Trial Locations

Locations (1)

Rigshospitalet; 🇩🇰 Copenhagen, Denmark