Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Phase I/II Randomized Study to Determine the Maximum Tolerated Dose, Safety, Pharmacokinetics and Antitumor Activity of Debio 1143 Combined With Concurrent Chemo-Radiation Therapy in Patients With Locally Advanced Squamous Cell Carcinoma of the Head and Neck.
Brief Summary: The use of multiple drugs in a single clinical trial or as a therapeutic strategy has become common, particularly in the treatment of cancer. Because traditional trials are designed to evaluate one agent at a time, the evaluation of therapies in combination requires specialized trial designs. In place of the traditional separate phase I and II trials, this trial uses a single phase I/II clinical trial to evaluate simultaneously the safety and efficacy of combination dose levels, and select the optimal combination dose.

Therefore, this is a two part trial of Debio 1143 combined with concurrent cisplatin and radiotherapy (CRT) in participants with previously untreated stage III, IVa or IVb head and neck cancer. The trial begins with an initial period of dose escalation (Phase I) to investigate the maximum tolerated dose (MTD) of Debio 1143 that can safely be given in combination with CRT.

Using the MTD determined in the Phase I portion, the randomized phase II trial in 94 participants compares Debio 1143 to placebo, both with concomitant CRT. The aim is to evaluate the efficacy and safety of Debio 1143.


Options:
A: Arm Label: Docetaxel Cisplatin 5-Fluorouracil (DCF); Type: EXPERIMENTAL; Interventions: Drug: DOCETAXEL, Drug: CISPLATIN, Drug: 5-FLUOROURACIL | Arm Label: Cisplatin 5-Fluorouracil (CF); Type: EXPERIMENTAL; Interventions: Drug: CISPLATIN, Drug: 5-FLUOROURACIL | Intervention Type: DRUG; Name: DOCETAXEL; Assigned to Arm(s): Docetaxel Cisplatin 5-Fluorouracil (DCF) | Intervention Type: DRUG; Name: CISPLATIN; Assigned to Arm(s): Cisplatin 5-Fluorouracil (CF), Docetaxel Cisplatin 5-Fluorouracil (DCF) | Intervention Type: DRUG; Name: 5-FLUOROURACIL; Assigned to Arm(s): Cisplatin 5-Fluorouracil (CF), Docetaxel Cisplatin 5-Fluorouracil (DCF)
B: Intervention Type: DRUG; Name: XRP6976 (Docetaxel/Taxotere); Assigned to Arm(s): N/A
C: 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
D: Arm Label: Debio 1143; Type: EXPERIMENTAL; Interventions: Drug: Cisplatin, Radiation: Radiotherapy, Drug: Debio 1143 | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Cisplatin, Radiation: Radiotherapy, Drug: Placebo | Intervention Type: DRUG; Name: Cisplatin; Assigned to Arm(s): Debio 1143, Placebo | Intervention Type: RADIATION; Name: Radiotherapy; Assigned to Arm(s): Debio 1143, Placebo | Intervention Type: DRUG; Name: Debio 1143; Assigned to Arm(s): Debio 1143 | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo

Answer: D