Hypopharyngeal Cancer, Oropharyngeal Cancer
Conditions
Keywords
Neoadjuvant, Concurrent Chemoradiotherapy,CCRT, Nimotuzumab, Locoregionally Advanced Oropharynx, Hypopharynx cancer, Randomized, Multicenter
Brief 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.
Interventions
* 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
RADIATIONIMRT
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
BIOLOGICALNimotuzumab
Nimotuzumab was administered 200 mg IV over 1 hour on day 1,once a week, for 13\ 14 weeks
Sponsors
Biotech Pharmaceutical Co., Ltd.
The Second People's Hospital of Sichuan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Informed consent form * Histologically confirmed locally advanced (stages III and IVb), squamous cell carcinoma of the oropharynx and hypopharynx * The tumor mass had to be measurable * Karnofsky performance status ≥70 * Life expectancy estimated than 6 months * Hematologic: WBC≥4×109 /L , plateletes≥100×109 /L, haemoglobin ≥100 g/L； * Hepatic: AST/ALT\<1.5 times upper limit of normal (ULN)；serum bilirubin\<1.5 times ULN; * Renal: Creatinine\<1.5 times ULN；
Exclusion criteria
* Known distant metastases * Primary tumor and nodes received surgery(except of biopsy) * Received other anti EGFR monoclonal antibody treatment * Previous chemotherapy or radiotherapy * Participation in other interventional clinical trials within 1 month * Other malignant tumor (except of non-melanoma skin Cancer or carcinoma in situ of cervix) * History of serious allergic or allergy * History of Serious lung or heart disease * Pregnancy or lactation women, or women with suspected pregnancy or men with willing to get pregnant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate | 3 months after all the treatment ending | Objective Response Rate: Complete response (CR)+ partial response (PR) rates base on RECIST evaluation system. |
| The Number of Participants with Adverse Events | Participants will be followed during the treatment and 3 months after all the treatment ending ,an expected average of 26 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the Local control Rate in 1 to 5 years. | Participants will be followed every year for the duration of 5 years | To evaluate each year until 5 years later |
| Overall Survival | From date of randomization until the date of death from any cause,assessed up to 5 years | — |
| Non-metastatic Rate | The time from randomization until distant relapse occur,assessed up to 5 years | — |
| Tumor-Free Survival | From date of randomization until the date of first documented occurrence of primary, neck, distant relapse,assessed up to 5 years | — |
| Progression-Free Survival | 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 | — |
Countries
China
Outcome results
None listed