Neoplasms

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Lymphoma

Hodgkin Disease

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Immunoproliferative Disorders

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Hodgkin Lymphoma

Antineoplastic Agents

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Bleomycin

Doxorubicin

Liposomal doxorubicin

Vinblastine

Dacarbazine

Two courses of ABVD. Early restaging with FDG-PET scan (PET-2)

The subsequent treatment will be as it follows:

* PET-2 positive patients will be high-dose salvage treatment;
* PET-2 negative patients will be treated with four additional courses of ABVD (for a total of six courses).

The following restaging procedures are planned as it follows:

* Optional: Whole body CT scan after the fourth course of ABVD; no therapy change will be made according to CT scan.
* Mandatory: Whole body CT and FDG-PET scans after the sixth course of ABVD (PET-6).

PET-6 negative patients will be randomized to first arm:

No radiotherapy.

Two courses of ABVD. Early restaging with FDG-PET scan (PET-2)

The subsequent treatment will be as it follows:

* PET-2 positive patients will be high-dose salvage treatment;
* PET-2 negative patients will be treated with four additional courses of ABVD (for a total of six courses).

The following restaging procedures are planned as it follows:

* Optional: Whole body CT scan after the fourth course of ABVD; no therapy change will be made according to CT scan.
* Mandatory: Whole body CT and FDG-PET scans after the sixth course of ABVD (PET-6).

PET-6 negative patients will be randomized to second arm:

Adjuvant radiotherapy (30 Gy) on sites of initial bulky disease.

ABVD courses are scheduled every 28 days:

Doxorubicin 25 mg/m2 i.v. day 1 and 15 Bleomycin 10 mg/m2 i.v. day 1 and 15 Vinblastine 6 mg/m2 i.v. day 1 and 15 Dacarbazine 375 mg/m2 i.v. day 1 and 15

ABVD courses are scheduled every 28 days:

Doxorubicin 25 mg/m2 i.v. day 1 and 15 Bleomycin 10 mg/m2 i.v. day 1 and 15 Vinblastine 6 mg/m2 i.v. day 1 and 15 Dacarbazine 375 mg/m2 i.v. day 1 and 15

Randomization to Arm A (Observation)

ABVD

ABVD courses are scheduled every 28 days:

Doxorubicin 25 mg/m2 i.v. day 1 and 15 Bleomycin 10 mg/m2 i.v. day 1 and 15 Vinblastine 6 mg/m2 i.v. day 1 and 15 Dacarbazine 375 mg/m2 i.v. day 1 and 15

Randomization to Arm B, Radiotherapy, in patients in CR, on the area of initial bulky disease (see above for the definition of nodal and/or mediastinal bulk).

ABVD and Radiotherapy

Alessandro Levis, MD

The purpose of this study is to define an improvement in patients:

* To evaluate if patients resistant to the initial treatment for residual PET-positive masses after the first two courses of ABVD (PET-2 positive), can be salvaged by early shift to high-dose chemotherapy supported by stem cell rescue
* To analyse if patients achieving early complete response (PET-2 negative), can be spared the adjuvant radiotherapy on areas of initial bulky disease, at the end of the planned six courses of ABVD. To answer this question, PET-2 negative patients will be randomized between radiotherapy versus no radiotherapy at the end of ABVD therapy.

This study is composed by two phases:

1. A phase II multi-centre study evaluating in patients with advanced stage Hodgkin lymphoma the efficacy of an early salvage treatment with high-dose chemotherapy followed by stem cell transplantation in patients FDG-PET positive after two courses of ABVD (PET-2 positive).
2. A phase III randomised study comparing the efficacy of radiotherapy to the areas of initial bulky disease versus no further therapy in PET-2 negative patients in complete remission (PET-6 negative) at the end of six courses of ABVD.

High-dose Chemotherapy and Stem Cell Transplantation, in Patients PET-2 Positive, After 2 Courses of ABVD and Comparison of RT Versus no RT in PET-2 Negative Patients

Early Salvage With High Dose Chemotherapy and Stem Cell Transplantation in Advanced Stage Hodgkin's Lymphoma Patients With Positive PET After Two Courses of ABVD (PET-2 Positive) and Comparison of RT Versus no RT in PET-2 Negative Patients

Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica Piemonte

Fondazione Italiana Linfomi - ETS

Spots Global Cancer Trial Database for abvd and radiotherapy