NCT01516996

Safety and Efficacy Study of Nimotuzumab Plus Neoadjuvant and Concurrent Chemoradiotherapy to Treat Oropharynx and Hypopharynx Cancer

Neoadjuvant and Concurrent Chemoradiotherapy Plus Nimotuzumab in Treating Patients With Locoregionally Advanced Squamous Cell Carcinoma of the Oropharynx and Hypopharynx

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: The Second People's Hospital of Sichuan · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficiency and safety of adding nimotuzumab to neoadjuvant and concurrent chemoradiotherapy in the treatment of patients with locoregionally advanced squamous cell carcinoma of the oropharynx and hypopharynx.

Detailed description

Locoregionally advanced squamous cell carcinoma of the head and neck(LA-SCCHN) poses one of the most complex management challenges. This stage of disease is still potentially curable, but requires combined-modality therapy. Recent studies have showed that induction chemotherapy（neoadjuvant）reduced the 3-year distant relapse rate. Concurrent chemoradiotherapy(CCRT), on the other hand, has demonstrated a significant and consistent benefit in local control rates, but its impact on distant failure is inconsistent. Nimotuzumab is a novel EGFR-targeting monoclonal antibody that has the potential.to be used as a single agent or as a radio- and chemotherapy sensitizer for the treatment of SCCHN. Thus, investigators conducted a randomized, multicenter phaseⅡ study to compare the efficiency and safety of adding nimotuzumab to neoadjuvant and CCRT with neoadjuvant and CCRT in the treatment of patients with locoregionally advanced squamous cell carcinoma of the oropharynx and hypopharynx.

Conditions

• Oropharyngeal Cancer
• Hypopharyngeal Cancer

Interventions

Type	Name	Description
DRUG	docetaxel and cisplatin	* The neoadjuvant consists of docetaxel 75mg/m2 day 1 and cisplatin 75mg/m2 days 1 to 3, repeat every 3 weeks, for 2 cycles. * CCRT: cisplatin 75mg/m2 is administered on day 1 of week 7,10 and 13 on current with RT
RADIATION	IMRT	IMRT is administered with chemotherapy from week 7 to week 13 * GTV（primary tumor）：68-70Gy/35\~38 F，once a day, 5 times per week * CTV（Clinical target）：56-66Gy/30\~36f，once a day, 5 times per week * GTV-ln（positive neck region）：66-70Gy/33\~36 F，once a day, 5 times per week * CTV-ln（negative neck region）：50-54Gy/28\~30F, once a day, 5 times
BIOLOGICAL	Nimotuzumab	Nimotuzumab was administered 200 mg IV over 1 hour on day 1,once a week, for 13\~14 weeks

Timeline

• Start date: 2012-03-01
• Primary completion: 2013-09-01
• Completion: 2018-03-01
• First posted: 2012-01-25
• Last updated: 2012-03-20

Locations

13 sites across 1 country: China