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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2012 by The Second People's Hospital of Sichuan
Sponsor:
Collaborator:
Biotech Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
LANG Jin-yi, The Second People's Hospital of Sichuan
ClinicalTrials.gov Identifier:
NCT01516996
First received: January 11, 2012
Last updated: March 18, 2012
Last verified: March 2012

January 11, 2012
March 18, 2012
March 2012
September 2013   (final data collection date for primary outcome measure)
  • Objective response rate [ Time Frame: 3 months after all the treatment ending ] [ Designated as safety issue: No ]
    Objective Response Rate: Complete response (CR)+ partial response (PR) rates base on RECIST evaluation system.
  • The Number of Participants with Adverse Events [ Time Frame: Participants will be followed during the treatment and 3 months after all the treatment ending ,an expected average of 26 weeks ] [ Designated as safety issue: Yes ]
    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.
Same as current
Complete list of historical versions of study NCT01516996 on ClinicalTrials.gov Archive Site
  • Overall Survival [ Time Frame: From date of randomization until the date of death from any cause,assessed up to 5 years ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Evaluate the Local control Rate in 1 to 5 years. [ Time Frame: Participants will be followed every year for the duration of 5 years ] [ Designated as safety issue: No ]
    To evaluate each year until 5 years later
  • 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 ] [ Designated as safety issue: No ]
  • Non-metastatic Rate [ Time Frame: The time from randomization until distant relapse occur,assessed up to 5 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Oropharyngeal Cancer
  • Hypopharyngeal Cancer
  • 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
    Other Name: CCRT
  • Biological: Nimotuzumab
    Nimotuzumab was administered 200 mg IV over 1 hour on day 1,once a week, for 13~14 weeks
  • Active Comparator: Neoadjuvant and CCRT
    Interventions:
    • Drug: docetaxel and cisplatin
    • Radiation: IMRT
  • Experimental: Neoadjuvant and CCRT and Nimotuzumab
    Interventions:
    • Drug: docetaxel and cisplatin
    • Radiation: IMRT
    • Biological: Nimotuzumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
80
March 2018
September 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
China
 
NCT01516996
BT-IST-SCCHN-036
Yes
LANG Jin-yi, The Second People's Hospital of Sichuan
The Second People's Hospital of Sichuan
Biotech Pharmaceutical Co., Ltd.
Principal Investigator: Yi J Lang, M.D. Radiotherapy department
The Second People's Hospital of Sichuan
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP