A Phase 2 interventional study of docetaxel and cisplatin and IMRT in Oropharyngeal Cancer and Hypopharyngeal Cancer, sponsored by The Second People's Hospital of Sichuan. Status unknown at 13 sites in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2012-03-20.
Sponsored by The Second People's Hospital of Sichuan · Phase 2, Interventional, and Treatment
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.
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.
373 studies on the registry are indexed under Oropharyngeal Neoplasms; 97 are open to participants now.
This study's planned enrollment of 80 is above the median of 48 across 284 interventional studies indexed under Oropharyngeal Neoplasms.
Browse Oropharyngeal Neoplasms studies →The Second People's Hospital of Sichuan is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: docetaxel and cisplatin · Radiation: IMRT
Drug: docetaxel and cisplatin · Radiation: IMRT · Biological: Nimotuzumab
* 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
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
Also known as: CCRT
Nimotuzumab was administered 200 mg IV over 1 hour on day 1,once a week, for 13\~14 weeks
Objective response rate
Objective Response Rate: Complete response (CR)+ partial response (PR) rates base on RECIST evaluation system.
Time frame: 3 months after all the treatment ending
The Number of Participants with Adverse Events
Record the Number of participants with adverse events and the Grades of the AE according to CTCAE v3.0 as the two measure of safety.
Time frame: Participants will be followed during the treatment and 3 months after all the treatment ending ,an expected average of 26 weeks
Overall Survival
Time frame: From date of randomization until the date of death from any cause,assessed up to 5 years
Progression-Free Survival
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years
Evaluate the Local control Rate in 1 to 5 years.
To evaluate each year until 5 years later
Time frame: Participants will be followed every year for the duration of 5 years
Tumor-Free Survival
Time frame: From date of randomization until the date of first documented occurrence of primary, neck, distant relapse,assessed up to 5 years
Non-metastatic Rate
Time frame: The time from randomization until distant relapse occur,assessed up to 5 years
This study is status unknown, as verified in Mar 2012. You cannot join it, but the record below documents what was studied.
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The Second People's Hospital of Sichuan