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

The Second People's Hospital of Sichuan

Status and phase

Unknown

Phase 2

Conditions

Oropharyngeal Cancer

Hypopharyngeal Cancer

Treatments

Drug: docetaxel and cisplatin

Biological: Nimotuzumab

Radiation: IMRT

Study type

Interventional

Funder types

Other

Identifiers

NCT01516996

BT-IST-SCCHN-036

Details and patient eligibility

About

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.

Full 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.

Enrollment

80 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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