Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Multiinstitutional Open Label Randomized Phase II Study Comparing Cetuximab and Radiotherapy Versus Cisplatin and Radiotherapy as Firstline Treatment for Patients With Locally Advanced Squamous Cell Carcinoma of the Head and Neck (LA-NHSCC)
Brief Summary: BACKGROUND:

Concomitant radiotherapy and cisplatin (CDDP) based chemotherapy is the standard treatment for LA-NHSCC. This combined modality treatment is linked with considerable acute local and systemic toxicity.EGFR is overexpressed in 90-100% of the HNSCC cases and is considered an unfavourable prognostic marker. EGFR costitutive activation is linked with HNSCC pathogenesis.

Cetuximab is a monoclonal anti-EGFR antibody blocking the activation of the receptor and signal transduction. Cetuximab combined with radiotherapy is superior to radiotherapy only in the treatment of LA-HNSCC and is characterized by an acceptable toxicity profile.

RATIONALE:

A direct comparison between concomitant chemoradiotherapy with Cisplatin and the concomitant treatment with radiotherapy associated to cetuximab does not exist.

STUDY DESIGN:

Arm A: Radical radiotherapy (doses and volumes) concomitant with chemotherapy with Cisplatin (40 mg/mq/week) Arm B: Radical radiotherapy (doses and volumes) concomitant with therapy with the monoclonal antibody Cetuximab (400 mg/m2 \["loading dose"\] and subsequently 250 mg /m2/week)


Options:
A: Intervention Type: BIOLOGICAL; Name: bleomycin sulfate; Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: fluorouracil; Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: leucovorin calcium; Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: methotrexate; Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: vincristine sulfate; Assigned to Arm(s): N/A | Intervention Type: RADIATION; Name: low-LET cobalt-60 gamma ray therapy; Assigned to Arm(s): N/A | Intervention Type: RADIATION; Name: low-LET photon therapy; Assigned to Arm(s): N/A | Intervention Type: RADIATION; Name: radiation therapy; Assigned to Arm(s): N/A
B: Arm Label: Taxotere, Cisplatin, 5-Fluorouracil (5-FU); Type: EXPERIMENTAL; Interventions: Drug: Taxotere, Cisplatin, 5-Fluorouracil (5-FU) | Intervention Type: DRUG; Name: Taxotere, Cisplatin, 5-Fluorouracil (5-FU); Assigned to Arm(s): Taxotere, Cisplatin, 5-Fluorouracil (5-FU)
C: Arm Label: Arm A: Nivolumab; Type: EXPERIMENTAL; Interventions: Drug: Nivolumab | Arm Label: Arm B: Cetuximab/Methotrexate/Docetaxel; Type: ACTIVE_COMPARATOR; Interventions: Drug: Cetuximab, Drug: Methotrexate, Drug: Docetaxel | Intervention Type: DRUG; Name: Nivolumab; Assigned to Arm(s): Arm A: Nivolumab | Intervention Type: DRUG; Name: Cetuximab; Assigned to Arm(s): Arm B: Cetuximab/Methotrexate/Docetaxel | Intervention Type: DRUG; Name: Methotrexate; Assigned to Arm(s): Arm B: Cetuximab/Methotrexate/Docetaxel | Intervention Type: DRUG; Name: Docetaxel; Assigned to Arm(s): Arm B: Cetuximab/Methotrexate/Docetaxel
D: Arm Label: cetuximab plus radiotherapy; Type: EXPERIMENTAL; Interventions: Drug: cetuximab | Arm Label: cisplatin plus radiotherapy; Type: ACTIVE_COMPARATOR; Interventions: Drug: cisplatin (associated to radiotherapy) | Intervention Type: DRUG; Name: cetuximab; Assigned to Arm(s): cetuximab plus radiotherapy | Intervention Type: DRUG; Name: cisplatin (associated to radiotherapy); Assigned to Arm(s): cisplatin plus radiotherapy

Answer: D