Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Concomitant cisplatin, 5-FU and radiotherapy · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| A | ACTIVE_COMPARATOR | Cisplatin from day 1 to day 4 and 5-FU for 4 days starting immediately after the end of cisplatin infusion on day 1. Both drugs were administered during week 1 and 6 of irradiation, starting from day 1 of weekly radiotherapy. |
| B | EXPERIMENTAL | Docetaxel followed by cisplatin and 5-FU from day 1 to day 4 starting after the end of cisplatin infusion. The cycle was repeated every 3 weeks up to a total of 3 cycles. After 3-6 weeks from the end of neoadjuvant chemotherapy, patients will receive with the same modality of arm A (reference arm). |
| Name | Type | Description |
|---|---|---|
| Docetaxel, cisplatin and 5-FU treatment followed by concomitant cisplatin, 5-FU and radiotherapy | DRUG | - |
| Concomitant cisplatin, 5-FU and radiotherapy | DRUG | - |
Inclusion criteria: * Histologically or cytologically proven squamous cell carcinoma of the head and neck. * Primary tumor sites eligible: oral cavity, oropharynx, hypopharynx. Although they are admittedly of squamous cell types, the following tumors will be excluded because of theY responsiveness ...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Bristol-Myers Squibb Company | BMY | 5 | PHASE3 | ACE-536 |
| AbbVie, Inc. | ABBV | 4 | PHASE3 | Navitoclax, Ruxolitinib |
| Novartis AG Sponsored ADR | NVS | 3 | PHASE3 | Pelabresib, Ruxolitinib |
| Karyopharm Therapeutics, Inc. | KPTI | 4 | PHASE3 | Selinexor, Ruxolitinib |
| Geron Corporation | GERN | 2 | PHASE3 | Imetelstat |
| Merck & Co., Inc. | MRK | 1 | PHASE3 | Bomedemstat |
| Incyte Corporation | INCY | 10 | PHASE2 | Ruxolitinib |
| GSK plc Sponsored ADR | GSK | 2 | PHASE2 | MMB |
| Takeda Pharmaceutical Co. Ltd. Sponsored ADR | TAK | 1 | PHASE2 | Elritercept, Ruxolitinib |
| Eli Lilly and Company | LLY | 1 | PHASE1 | LY3410738, Venetoclax, Azacitidine |
| Disc Medicine, Inc. | IRON | 1 | PHASE1 | DISC-0974 |
| Galecto, Inc. | GLTO | 1 | PHASE2 | GB2064 |
| Prelude Therapeutics, Inc. | PRLD | 1 | PHASE1 | PRT12396 |
| United Therapeutics Corporation | UTHR | 1 | PHASE2 | bomedemstat |
Concomitant cisplatin, 5-FU and radiotherapy is used for head and neck neoplasms, specifically in the treatment of locally advanced squamous cell carcinoma of the head and neck. It is an investigational combination regimen being studied in a Phase 2 clinical trial.
Concomitant cisplatin, 5-FU and radiotherapy is developed by Sanofi, a company traded under the ticker SNY. The regimen combines the small molecule drugs cisplatin and 5-fluorouracil with radiotherapy for the treatment of head and neck cancer.
Concomitant cisplatin, 5-FU and radiotherapy is in Phase 2 clinical development. It is an investigational regimen, not yet approved by regulatory authorities, and has completed one Phase 2 trial in patients with head and neck cancer.
Concomitant cisplatin, 5-FU and radiotherapy has been studied in one completed clinical trial, NCT00357149. This Phase 2 trial enrolled 101 patients in Italy and evaluated neoadjuvant docetaxel plus cisplatin and 5-fluorouracil followed by concomitant chemoradiotherapy versus chemoradiotherapy alone in locally advanced squamous cell carcinoma of the head and neck.
Concomitant cisplatin, 5-FU and radiotherapy is a form of chemoradiotherapy, combining the chemotherapy drugs cisplatin and 5-fluorouracil with radiation therapy. In the clinical trial NCT00357149, it was compared against chemoradiotherapy alone, indicating it is a specific regimen within the broader category of chemoradiotherapy.