Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Randomized Phase III Study of a Treatment Driven by Early PET Response Compared to a Treatment Not Monitored by Early PET in Patients With Ann Arbor Stage III-IV or High Risk IIB Hodgkin Lymphoma
Brief Summary: All study treatments have proven efficacy in the treatment in Hodgkin lymphoma (HL). It is hoped that patients will achieve a good response to both induction therapies consisting either of 4 cycles of BEACOPPesc (Bleomycin, Etoposide, Doxorubicin, Cyclophosphamide, Vincristine, Procarbazine, and Prednisone) or 2 cycles of BEACOPPesc plus 2 cycles of ABVD (Adriamycine, Bléomycine, Vinblastine, Décarbazine).

The use of F-FDG Position Emission Tomography performed after 2 cycles of chemotherapy (PET2) in the experimental arm will help to stratify patients in order to restrict the BEACOPPesc therapy continuation to those patients who achieved only a partial response after 2 BEACOPPesc regimen and to allow a conventional dose ABVD chemotherapy strategy for PET2 negative patients. For all patients included in the trial the achievement of a good response to induction treatment will be checked after four cycles of induction treatment including a centrally reviewed PET assessment

Patients will be randomized after verification of eligibility and before the start of the protocol treatment.Patients will be randomly assigned to the standard treatment arm not monitored by early PET, or the experimental treatment arm driven by the PET2 result.


Options:
A: Arm Label: Favorable - Standard - any PET outcome; Type: ACTIVE_COMPARATOR; Interventions: Drug: ABVD q4 weeks, Radiation: IN-RT 30 Gy (+ boost 6 Gy residual), Procedure: FDG-PET scan | Arm Label: Favorable - Experimental - PET negative; Type: EXPERIMENTAL; Interventions: Drug: ABVD q4 weeks, Procedure: FDG-PET scan | Arm Label: Favorable - Experimental - PET positive; Type: EXPERIMENTAL; Interventions: Drug: BEACOPP escalated q3 weeks, Radiation: IN-RT 30 Gy (+ boost 6 Gy residual), Procedure: FDG-PET scan | Arm Label: Unfavorable - Standard - Any PET outcome; Type: ACTIVE_COMPARATOR; Interventions: Drug: ABVD q4 weeks, Radiation: IN-RT 30 Gy (+ boost 6 Gy residual), Procedure: FDG-PET scan | Arm Label: Unfavorable - Experimental - PET negative; Type: EXPERIMENTAL; Interventions: Drug: ABVD q4 weeks, Procedure: FDG-PET scan | Arm Label: Unfavorable - Experimental - PET positive; Type: EXPERIMENTAL; Interventions: Drug: BEACOPP escalated q3 weeks, Radiation: IN-RT 30 Gy (+ boost 6 Gy residual), Procedure: FDG-PET scan | Intervention Type: DRUG; Name: ABVD q4 weeks; Assigned to Arm(s): Favorable - Experimental - PET negative, Favorable - Standard - any PET outcome, Unfavorable - Experimental - PET negative, Unfavorable - Standard - Any PET outcome | Intervention Type: DRUG; Name: BEACOPP escalated q3 weeks; Assigned to Arm(s): Favorable - Experimental - PET positive, Unfavorable - Experimental - PET positive | Intervention Type: RADIATION; Name: IN-RT 30 Gy (+ boost 6 Gy residual); Assigned to Arm(s): Favorable - Experimental - PET positive, Favorable - Standard - any PET outcome, Unfavorable - Experimental - PET positive, Unfavorable - Standard - Any PET outcome | Intervention Type: PROCEDURE; Name: FDG-PET scan; Assigned to Arm(s): Favorable - Experimental - PET negative, Favorable - Experimental - PET positive, Favorable - Standard - any PET outcome, Unfavorable - Experimental - PET negative, Unfavorable - Experimental - PET positive, Unfavorable - Standard - Any PET outcome
B: Arm Label: Arm A; Type: ACTIVE_COMPARATOR; Interventions: Drug: Adriamycin, Drug: Bleomycin, Drug: Vinblastine, Drug: DTIC, Radiation: 30 Gy IF-RT | Arm Label: Arm B; Type: EXPERIMENTAL; Interventions: Drug: Adriamycin, Drug: Bleomycin, Drug: Vinblastine, Drug: DTIC, Radiation: 20 Gy IF-RT | Arm Label: Arm C; Type: EXPERIMENTAL; Interventions: Drug: Adriamycin, Drug: Bleomycin, Drug: Vinblastine, Drug: DTIC, Radiation: 30 Gy IF-RT | Arm Label: Arm D; Type: EXPERIMENTAL; Interventions: Drug: Adriamycin, Drug: Bleomycin, Drug: Vinblastine, Drug: DTIC, Radiation: 20 Gy IF-RT | Intervention Type: DRUG; Name: Adriamycin; Assigned to Arm(s): Arm A, Arm B, Arm C, Arm D | Intervention Type: DRUG; Name: Bleomycin; Assigned to Arm(s): Arm A, Arm B, Arm C, Arm D | Intervention Type: DRUG; Name: Vinblastine; Assigned to Arm(s): Arm A, Arm B, Arm C, Arm D | Intervention Type: DRUG; Name: DTIC; Assigned to Arm(s): Arm A, Arm B, Arm C, Arm D | Intervention Type: RADIATION; Name: 30 Gy IF-RT; Assigned to Arm(s): Arm A, Arm C | Intervention Type: RADIATION; Name: 20 Gy IF-RT; Assigned to Arm(s): Arm B, Arm D
C: Arm Label: A; Type: ACTIVE_COMPARATOR; Interventions: Drug: BEACOPP escalated | Arm Label: B; Type: EXPERIMENTAL; Interventions: Drug: Rituximab, Drug: BEACOPP escalated | Arm Label: C; Type: ACTIVE_COMPARATOR; Interventions: Drug: BEACOPP escalated | Arm Label: D; Type: EXPERIMENTAL; Interventions: Drug: BEACOPP escalated | Intervention Type: DRUG; Name: Rituximab; Assigned to Arm(s): B | Intervention Type: DRUG; Name: BEACOPP escalated; Assigned to Arm(s): A, B, C, D
D: Arm Label: Standard arm; Type: ACTIVE_COMPARATOR; Interventions: Drug: BEACOPPesc | Arm Label: Experimental arm; Type: EXPERIMENTAL; Interventions: Drug: BEACOPPesc - ABVD - PET2 | Intervention Type: DRUG; Name: BEACOPPesc; Assigned to Arm(s): Standard arm | Intervention Type: DRUG; Name: BEACOPPesc - ABVD - PET2; Assigned to Arm(s): Experimental arm

Answer: D