Head and neck cancer clinical trials results

carboplatin, 5FU versus PF
De Andres, 1995	induction chemotherapy with carboplatin and fluorouracil versus induction chemotherapy with cisplatin and fluorouracil	stage IV-M0 head and neck cancer	open Follow-up duration: minimum 5y Spain
CT with methotrexate versus no induction chemotherapy
Fazekas (RTOG 6801), 1980	induction chemotherapy with methotrexate followed by radiotherapy +/- post radiotherapy surgery versus radiotherapy alone +/- post radiotherapy surgery	locally advanced squamous cell carcinoma or lymphoepithelioma of the oral cavity, oropharynx, supraglottic larynx or hypopharynx	open Follow-up duration: 1.67y mean US
Richard (IGR-65), 1974	Intra arterial infusion chemotherapy with methotrexate followed by radiotherapy versus radiotherapy alone	avanced cancer (T4) of the oral cavity and oropharynx	Open Follow-up duration: 5 years at least France
induction PF versus surgery
GETTEC, 1998	induction chemotherapy with cisplatin and fluorouracil, followed by radiotherapy in good responders, and by total laryngectomy plus radiotherapy in poor responders versus total laryngectomy followed by radiotherapy	advanced (T3) larynx carcinoma considered for total laryngectomy	Open Follow-up duration: median 5 y France
Veterans Affairs, 1998	three cycles of chemotherapy (cisplatin and fluorouracil) and definitive radiotherapy versus conventional laryngectomy and postoperative surgery	stage III and IV previously untreated carcinoma of the larynx	open Follow-up duration: 2.75y median (0.9-5.2) USA
EORTC 24891, 1996 EORTC 24891	induction chemotherapy with cisplatin plus fluorouracil + radiotherapy or surgery + post operative surgery versus total laryngectomy + postoperative radiotherapy	squamous cell carcinomas of the pyriform sinus or aryepiglottic fold	open Follow-up duration: 4.25 years median (0.25-8.8) Europe
nivolumab versus standard treatment
Checkmate-141, 2016 NCT02105636	nivolumab (at a dose of 3 mg per kilogram of body weight) every 2 weeks versus standard, single-agent systemic therapy (methotrexate, docetaxel, or cetuximab).	patients with recurrent squamous-cell carcinoma of the head and neck whose disease had progressed within 6 months after platinum-based chemotherapy	open-label
paclitaxel based CT versus PF
Hitt paclitaxel, 2005	induction chemotherapy with paclitaxel, cisplatin, and fluorouracil versus induction chemotherapy with cisplatin and FU	locally advanced head and neck cancer	Open Follow-up duration: 1.93y (0.025-5y) Spain
PBM versus PF
Clark (Dana farber cancer Institute 83-084), 1988	induction chemotherapy with bleomycin, cisplatin, LTX, leucovorin (PBM) followed by local treatment (surgery and/or radiotherapy) versus induction chemotherapy with cisplatin, 5FU followed by local treatment (surgery and/or radiotherapy)	patients with previously untreated stage III and IV squamous cell carcinomas of head and neck (SCCHN)	open US
pembrolizumab versus standard treatment
KEYNOTE-040, NCT02252042	pembrolizumab 200 mg intravenous (IV) on Day 1 of each 3-week cycle versus standard treatment (methotrexate, docetaxel or cetuximab)	patients with recurrent or metastatic head and neck squamous cell cancer	open-design
PF versus no induction chemotherapy
Dalley (AHNTG), 1995	induction chemotherapy with cisplatin, fluorouracil followed by definitive local therapy versus definitive local therapy alone	locally advanced untreated squamous cell carcinoma of head and neck	open Follow-up duration: 4.8y Australia
Licitra, 2003 NCT00002747	induction chemotherapy with cisplatin and fluorouracil followed by surgery +/- radiotherapy versus surgery alone +/- radiotherapy	resectable untreated oral cavity squamous cell carcinoma	Open Follow-up duration: 6.3 y median Italy
RTOG 91-11 (I+RT vs RT alone), 2003	induction cisplatin plus fluorouracil followed by radiotherapy, versus radiotherapy alone	locally advanced cancer of the larynx requiring total laryngectomy	Open Follow-up duration: 6.9y (median) USA
Hareyama, 2002	two courses of chemotherapy, consisting of cisplatin and 5-fluorouracil (CDDP-5FU), that were administered before radiation therapy versus radiotherapy alone	locoregional carcinoma of the nasopharynx	Open Follow-up duration: 4.08 y (median) (range 0.3-9.2 Japan
Domenge (GETTEC), 2000	induction chemotherapy with cisplatin plus fluorouracil followed by loco-regional treatment consisted either of surgery plus radiotherapy or of radiotherapy alone versus locoregional treatment consisted either of surgery plus radiotherapy or of radiotherapy alone	Patients with a squamous cell carcinoma of the oropharynx for whom curative radiotherapy or surgery was considered feasible	Open Follow-up duration: 5y median France
Lewin (SHNG-85), 1997	induction chemotherapy (Cisplatin, 5 FU) followed by radiotherapy +/- surgery versus radiotherapy alone +/- surgery	Patients with non resectable squamous cell carcinoma of the oropharynx, hypopharynx and larynx, stage III to IV, or with resectable and non resectable tumor of the oral cavity stage II to IV	open Follow-up duration: 4.5y mean, 1.5-8y Denmark, Norway, Sweden
Gedouin (Rennes-87), 1996	induction chemotherapy (cisplatin + 5FU) before regional treatment versus regional treatment alone	patients with squamous cell carcinoma of hypopharynx and base of tongue	open Follow-up duration: 5y median France
Hasegawa (HNAP-02), 1996	2 cycles of neoadjuvant CT: CDDP (70mg/m2, day 1) and 5FU (660mg/m2, day 2-6) followed by surgery versus surgery (without preoperative treatment)	patients with resectable previously untreated advanced head and neck squamous cell carcinoma (stage III/IV M0)	Follow-up duration: 3.7y
Domenge (GETTEC neo1), 1995	induction chemotherapy with cisplatin plus fluorouracil followed by radiotherapy versus radiotherapy	oropharyngeal tumor	open Follow-up duration: median 3y France
Di Blasio (Parma), 1994	induction chemotherapy with cisplatin, fluorouracil followed by locoregional treatment versus locoregional treatment alone	stage II-IV resectable head and neck cancer	open Follow-up duration: median 4y (1.9-6.25) Italy
Volling (Cologne), 1994	Induction chemotherapy (carboplatin, 5-FU) + surgery + postoperative radiotherapy versus surgery + postoperative radiotherapy	resectable stage T2-T3, N0-N2 carcinomas of oral cavity, oro- and hypopharynx and a performance status of at least 2	Open Follow-up duration: 1.75y (range 1-2y) Deutschland
Paccagnella (GSTTC-86 ), 1994	four cycles of cisplatin and 5-fluorouracil followed by locoregional treatment versus locoregional treatment alone	histologically proven squamous cell carcinoma of the hypopharynx, oropharynx, oral cavity, or paranasal sinus; stage III or IV disease without distant metastases	open Follow-up duration: median 12.5 y range 10.7-14,6 Italy
Depondt (CFHNS), 1993	carboplatin 400mg/m2 x3, fluorouracil 5000mg/m2 x3 versus RT or S+RT	patients with head and neck cancer	Follow-up duration: 2.1y France
Tejedor (Las Palmas), 1992	three courses of induction chemotherapy followed by radiotherapy versus radiotherapy alone	Patients with locally advanced squamous cell carcinoma of the head and neck, stages III-IV, M0	Open Follow-up duration: 1y minimum Spain
Toohill (MCW-2), 1987	induction chemotherapy (cisplatin, fluorouracil) + radiotherapy (50 Gy) + surgery versus radiotherapy (50 Gy) + surgery	advanced squamous cell carcinoma of the upper aerodigestive tract	Open Follow-up duration: 24-44 months US
BNH 003, 0	cisplatin 100mg/m2 x2-3, 5 fluorouracil 4000 mg/m2 x2-3 versus surgery + radiotherapy		Follow-up duration: NA
EORTC 24844, 0 EORTC-24844	Induction Chemotherapy with Cisplatin and fluorouracil followed by Surgery followed by Radiotherapy versus Surgery followed by Radiotherapy	Advanced Squamous Cell Carcinoma of the Lateral Oropharynx and Lateral Posterior Oral Cavity	Open Follow-up duration: NA
PF with leucovorin versus PF without leucovorin
Fonseca, 1997	induction chemotherapy with cisplatin,5FU and leucovorin versus induction chemotherapy with cisplatin and 5FU	Stage III-IVa locally advanced head and neck cancer	Open Follow-up duration: NA Spain
polyCT with platin versus cisplatin
Chauvergne, 1988	cisplatin, vincristin, methotrexate, bleomycin versus cisplatin alone	unresectable advanced squamous cell carcinoma of head and neck	open france
polyCT with platin versus no induction chemotherapy
Kohno, 2000	induction chemotherapy with cisplatin, etoposide, mitomycin-C followed by surgery versus surgery alone	patients with previously untreated stage III and IV resectable squamous cell carcinoma of the oral cavity and pharynx	Open Follow-up duration: 5.6y (5-6.6y) Japan
Maipang (Songkla), 1995	induction chemotherapy + surgery + post operative radiotherapy versus surgery + post operative radiotherapy	advanced stage III and IV SCCHN with resectable tumor	open Follow-up duration: NA Thailand
Mazeron (Créteil-82), 1992	induction chemotherapy (bleomycin, methotrexate, 5-fluorouracil, cisplatin) + locoregional treatment (+/- surgery + radiotherapy) versus locoregional treatment alone (+/- surgery + radiotherapy )	Stage II-IV squamous cell carcinoma of the oropharynx or oral cavity	Open Follow-up duration: NA france
Jaulerry Trial 2 (Curie)(HNCGIC03), 1992	induction chemotherapy (cisplatin,5FU, vindesine) + radiotherapy +/- surgery versus radiotherapy	T3, T4 tumors of the oropharynx, hypopharynx, larynx, oral cavity and T2 hypopharynx	Open Follow-up duration: 2.5 y (0.83-3.4y) france
Salvajoli (AC Camargo), 1992	induction chemotherapy (vinblastine, mitomycin, cisplatin, bleomycin) and radiotherapy (70 Gy) versus radiotherapy alone (70 Gy)	Patients with unresectable stage IV squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx	open Follow-up duration: 2.3y median Brazil
Brunin (HNCGIC02), 1989	induction chemotherapy (cisplatin, bleomycin, vindesine, mitomycin) prior radiotherapy (55 Gy) +/- surgery versus radiotherapy (55 Gy) +/- surgery alone	stage III and IV carcinomas of the oral cavity, oropharynx and larynx and stage II carcinomas of the hypopharynx	open Follow-up duration: 2.9y median, range 1.2-4.6 France
Schuller (SWOG 8006), 1988	induction chemotherapy, surgery and post operative radiotherapy versus surgery and post operative radiotherapy	operable stage III-IV epidermoid carcinoma of the head and neck	open Follow-up duration: median 5y US
Szpirglas (Pitié-81 ), 1988	versus
Carugati (Buenos Aires ), 1988	induction chemotherapy before radical treatment versus radical treatment	stage III and IV of SSC of the oral cavity, larynx, oropharynx	open Follow-up duration: 5 y Argentina
HNCP, 1987	induction chemotherapy (cisplatin + bleomycin) + surgery + postoperative radiotherapy versus surgery + radiotherapy	resectable stage III or IV cancers of the oral cavity, larynx or hypopharynx	open Follow-up duration: median 5.1y (range 3.1-6.6) US
polyCT without platin versus no induction chemotherapy
Richard (EORTC 78-OCP), 1991	intraarterial induction chemotherapy (vincristine, bleomycin) + surgery + post operative radiotherapy versus surgery + post operative radiotherapy	Squamous cell carcinoma of the oral cavity and oropharynx	open Follow-up duration: median 5y (range 1-9y) europe
Jortay (EORTC 24771), 1990	induction chemotherapy with vincristine, bleomycin, methotrexate followed by surgery +/- radiotherapy versus surgery +/- radiotherapy	operable epidermoid carcinoma of the pyriform sinus	open Follow-up duration: 5y mean France, Italy
Holoye (MCW-1), 1985	induction chemotherapy (bleomycin, cytoxan, MTX, 5FU) + standard treatment (preoperative radiotherapy followed by surgery) versus standard treatment (preoperative radiotherapy followed by surgery)	Stage III and IV squamous cell carcinoma of oral cavity, oropharynx, nasopharynx, nasal cavity or paranasal sinuses, larynx hypopharynx and stage II of pyriform sinus	open Follow-up duration: at least 2y post diagnosis US
TP versus PF
Fonseca, 2005	induction CT with cisplatin/docetaxel versus induction CT with cisplatin and 5-fluorouracil (PF)	patients chemotherapy-naïve with locally advanced resectable and non-resectable SCCHN	Open Follow-up duration: NA Spain
TPF versus PF
Posner (TAX324), 2007 NCT00273546	induction chemotherapy consisting of docetaxel added to cisplatin/5-FU (TPF) followed by chemoradiotherapy versus standard cisplatin/5-FU (PF) induction chemotherapy followed by chemoradiotherapy	locally advanced (stage III/IV) squamous cell carcinoma of head and neck with unresectable tumor or candidates for organ preservation	open Follow-up duration: >24 months US, Canada, Argentina, Europe
EORTC 24971 (TAX 323), 2006 NCT00003888	induction chemotherapy with docetaxel + cisplatin + 5 FU followed by radiotherapy +/- surgery (before or after radiotherapy) versus induction chemotherapy with cisplatin + 5 FU followed by radiotherapy +/- surgery (before or after radiotherapy)	patients with stage III or IV unresectable locally advanced SCCHN	Open Follow-up duration: 1.75 y Europe
GORTEC 2000-01, 0 NCT00169182	induction chemotherapy with docetaxel + cisplatin + 5-FU versus induction chemotherapy with cisplatin + fluorouracil	patients with locally advanced larynx and hypopharynx tumors requiring initially total laryngectomy	open Follow-up duration: NA France
TAX324 (Larynx preservation subset), 2007 NCT00273546	induction chemotherapy consisting of docetaxel added to cisplatin/5-FU (TPF) followed by chemoradiotherapy , induction chemotherapy consisting of docetaxel added to cisplatin/5-FU (TPF) followed by chemoradiotherapy versus standard cisplatin/5-FU (PF) induction chemotherapy followed by chemoradiotherapy	locally advanced (stage III/IV) squamous cell carcinoma of larynx and hypopharynx, candidates for organ preservation	open Follow-up duration: >24 months US, Canada, Argentina, Europe
VP16 based CT versus PF
Prévost, 2005	induction chemotherapy with cisplatin+VP16 + radiotherapy versus induction chemotherapy with cisplatin+5-FU+ radiotherapy	patient with unresectable advanced head and neck cancer	open Follow-up duration: NA France