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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2018-03-31

Brief Summary

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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.

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Detailed Description

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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

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Oropharyngeal Cancer Hypopharyngeal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Neoadjuvant and CCRT

Group Type ACTIVE_COMPARATOR

docetaxel and cisplatin

Intervention Type DRUG

* 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

Intervention Type RADIATION

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

Neoadjuvant and CCRT and Nimotuzumab

Group Type EXPERIMENTAL

docetaxel and cisplatin

Intervention Type DRUG

* 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

Intervention Type RADIATION

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

Nimotuzumab

Intervention Type BIOLOGICAL

Nimotuzumab was administered 200 mg IV over 1 hour on day 1,once a week, for 13\~14 weeks

Interventions

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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

Intervention Type DRUG

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

Intervention Type RADIATION

Nimotuzumab

Nimotuzumab was administered 200 mg IV over 1 hour on day 1,once a week, for 13\~14 weeks

Intervention Type BIOLOGICAL

Other Intervention Names

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CCRT

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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LANG Jin-yi

Professor of radiotherapy department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yi J Lang, M.D.

Role: PRINCIPAL_INVESTIGATOR

Radiotherapy department

Locations

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