scholarly journals Postoperative Bio-Chemoradiotherapy Using Cetuximab and Docetaxel in Patients With Cis-Platinum–Intolerant Core High-Risk Head and Neck Cancer: Protocol of a Phase 2 Nonrandomized Clinical Trial

10.2196/11003 ◽  
2018 ◽  
Vol 7 (8) ◽  
pp. e11003
Author(s):  
Goshi Nishimura ◽  
Hiromitsu Hatakeyama ◽  
Osamu Shiono ◽  
Masataka Taguri ◽  
Masanori Komatsu ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Head And Neck Cancer ◽  
High Risk ◽  
Head And Neck ◽  
Neck Cancer ◽  
Phase 2

scholarly journals Postoperative Bio-Chemoradiotherapy Using Cetuximab and Docetaxel in Patients With Cis-Platinum�Intolerant Core High-Risk Head and Neck Cancer: Protocol of a Phase 2 Nonrandomized Clinical Trial (Preprint)

2018 ◽  
Author(s):  
Goshi Nishimura ◽  
Hiromitsu Hatakeyama ◽  
Osamu Shiono ◽  
Masataka Taguri ◽  
Masanori Komatsu ◽  
...  
Keyword(s):  
Head And Neck Cancer ◽  
High Risk ◽  
Head And Neck ◽  
Neck Cancer ◽  
Disease Free Survival ◽  
Positive Margin ◽  
Phase 2 ◽  
Free Survival ◽  
Number Of Patients ◽  
Disease Free

BACKGROUND We confirmed the safety of postoperative bio-chemoradiotherapy using cetuximab and docetaxel in a small number of patients with cis-platinum–intolerant core high-risk head and neck cancer. OBJECTIVE To assess treatment efficacy, we planned a phase 2 study of postoperative bio-chemoradiotherapy for patients with cis-platinum–intolerant core high-risk head and neck cancer and will compare the results to those of previously collected radiotherapy data. METHODS Patients who underwent definitive surgery for oral cavity, laryngeal, oropharyngeal, or hypopharyngeal advanced cancer, whose postoperative pathological results indicated core high risk for recurrence (eg, positive margin in the primary site or extranodal extension) and who were cis-platinum–intolerant, will undergo postoperative bio-chemoradiotherapy. The primary end point is 2-year disease-free survival. RESULTS The expected 2-year disease-free survival is set at 55%, and the calculated sample size is 35 patients, according to a statistical analysis based on previous reports. CONCLUSIONS This treatment method is expected to improve the survival rate of patients with severe head and neck cancer. CLINICALTRIAL UMIN Clinical Trials Registry UMIN000031835; https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ ctr_view.cgi?recptno=R000036355 (Archived by WebCite at http://www.webcitation.org/71fejVjMr)

Randomized clinical trial on 7-days-a-week postoperative radiotherapy for high-risk squamous cell head and neck cancer

2008 ◽  
Vol 87 (2) ◽  
pp. 155-163 ◽  
Author(s):  
Rafał Suwiński ◽  
Magdalena Bańkowska-Woźniak ◽  
Wojciech Majewski ◽  
Adam Idasiak ◽  
Adam Maciejewski ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Head And Neck Cancer ◽  
High Risk ◽  
Head And Neck ◽  
Randomized Clinical Trial ◽  
Neck Cancer ◽  
Squamous Cell ◽  
Postoperative Radiotherapy

Results of a phase II randomized controlled clinical trial comparing efficacy of cabazitaxel versus docetaxel as second-line or above therapy in recurrent head and neck cancer.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 6018-6018 ◽  
Author(s):  
Amit Joshi ◽  
Vijay Maruti Patil ◽  
Vanita Noronha ◽  
Sachin Dhumal ◽  
Arun Chandrasekharan ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Head And Neck Cancer ◽  
Disease Control ◽  
Head And Neck ◽  
Neck Cancer ◽  
Disease Control Rate ◽  
Phase 2 ◽  
Randomized Controlled ◽  
Phase 2 Study ◽  
Recurrent Head

6018 Background: Cabazitaxel has shown activity in squamous cancer cell lines and in taxane resistant cell lines. Hence we planned a randomized phase 2 study to evaluate the efficacy and safety of cabazitaxel against docetaxel in recurrent head and neck cancer, post first line treatment. Methods: This was a phase 2 open label, investigator initiated, randomized controlled trial of Docetaxel (75 mg/m2) versus Cabazitaxel (20 mg/m2), in adult patients with head and neck cancer, ECOG performance status 0-2, with measurable disease, who have been exposed to at least one line of chemotherapy (CTRI/2015/06/005848). 1:1 central randomization was performed and chemotherapy was administered till progressive disease or until patient had intolerable side effects. The sample size of 92 (46 per group) was determined based on an assumption for a difference in disease control rate of 25%, an alpha of 0.05 and 80% power. The data was censored for analysis on 3rd March 2017. Primary analysis of disease control at 6 weeks (CR/PR/SD) was assessed and compared using the chi-square test. Progression free survival (PFS) and overall survival (OS) curves were estimated using the Kaplan-Meier method. Cox proportional hazard model was used for comparison of PFS and OS between the 2 arms. Results: 92 patients were accrued in the study with 46 in each arm. The disease control rate at 6 weeks was better in the docetaxel arm which was statistically significant over the cabazitaxel arm (13.6% versus 52.3%, p = 0.017). The median PFS was 21 days (95% CI 5.28-36.72 days) in the cabazitaxel arm versus 61 days (95% CI 16.21 to 105.79 days) in the docetaxel arm (HR = 1.466, 95% CI 0.923-2.328, p = 0.105). The median OS was 172 days (95% CI 111.78 to 232.22 days) in the cabazitaxel arm versus 188 days (95% CI 134.4 to 241.6 days) in the docetaxel arm (HR-1.408, 95% CI 0.738-2.688, p = 0.299). Conclusion: In this phase 2 study, docetaxel had a superior disease control rate at 6 weeks and PFS compared to cabazitaxel. Clinical trial information: CTRI/2015/06/005848.

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