HD17 for Intermediate Stage Hodgkin Lymphoma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-13

Study Completion Date

2020-03-23

Brief Summary

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This study is designed to test the non-inferiority of the experimental arm compared to the standard arm in terms of progression free survival (PFS).

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Detailed Description

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Conditions

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Hodgkin Lymphoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm A

2 cycles BEACOPPescalated plus 2 cycles ABVD followed by 30Gy IF-RT irrespective of FDG-PET results after chemotherapy

Group Type ACTIVE_COMPARATOR

BEACOPPescalated (Bleomycin, Etoposide, Adriamycin, Cyclophosphamide, Vincristine, Procarbazine, Prednisone)

Intervention Type DRUG

ABVD (Adriamycin, Bleomycin, Vinblastine, Dacarbazine)

Intervention Type DRUG

30Gy IF-RT (Involved-Field Radiotherapy)

Intervention Type RADIATION

Arm B

2 cycles BEACOPPescalated plus 2 cycles ABVD followed by 30Gy IN-RT if FDG-PET is positive after chemotherapy; 2 cycles BEACOPPescalated plus 2 cycles ABVD and treatment stop if FDG-PET is negative after chemotherapy

Group Type EXPERIMENTAL

BEACOPPescalated (Bleomycin, Etoposide, Adriamycin, Cyclophosphamide, Vincristine, Procarbazine, Prednisone)

Intervention Type DRUG

ABVD (Adriamycin, Bleomycin, Vinblastine, Dacarbazine)

Intervention Type DRUG

30Gy IN-RT (Involved-Node Radiotherapy)

Intervention Type RADIATION

Interventions

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BEACOPPescalated (Bleomycin, Etoposide, Adriamycin, Cyclophosphamide, Vincristine, Procarbazine, Prednisone)

Intervention Type DRUG

ABVD (Adriamycin, Bleomycin, Vinblastine, Dacarbazine)

Intervention Type DRUG

30Gy IF-RT (Involved-Field Radiotherapy)

Intervention Type RADIATION

30Gy IN-RT (Involved-Node Radiotherapy)

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

* Hodgkin Lymphoma
* CS I, II with risk factor (stage IIB with risk factor 1 or 2 are not included)
* large mediastinal mass (\>1/3 of maximum transverse thorax diameter)
* extranodal involvement
* elevated ESR
* 3 or more involved nodal areas
* written informed consent