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 canceropen
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 hypopharynxopen
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 oropharynxOpen
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 laryngectomyOpen
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 larynxopen
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 foldopen
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 cancerOpen
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 canceropen-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 carcinomaOpen
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 laryngectomyOpen
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 nasopharynxOpen
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 feasibleOpen
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 IVopen
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 tongueopen
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 tumoropen
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 canceropen
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 2Open
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 metastasesopen
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, M0Open
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 tractOpen
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 CavityOpen
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 cancerOpen
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 pharynxOpen
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 tumoropen
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 cavityOpen
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 hypopharynxOpen
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, hypopharynxopen
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 neckopen
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, oropharynxopen
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 hypopharynxopen
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 oropharynxopen
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 sinusopen
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 sinusopen
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 SCCHNOpen
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 preservationopen
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 SCCHNOpen
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 laryngectomyopen
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 canceropen
Follow-up duration: NA
France