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
  Purpose

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.


Condition Intervention Phase
Oropharyngeal Cancer
Hypopharyngeal Cancer
Drug: docetaxel and cisplatin
Radiation: IMRT
Biological: Nimotuzumab
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Neoadjuvant and Concurrent Chemoradiotherapy Plus Nimotuzumab in Treating Patients With Locoregionally Advanced Squamous Cell Carcinoma of the Oropharynx and Hypopharynx

Resource links provided by NLM:


Further study details as provided by The Second People's Hospital of Sichuan:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 80
Study Start Date: March 2012
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Neoadjuvant and CCRT 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
Experimental: Neoadjuvant and CCRT and Nimotuzumab 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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01516996

Locations
China, Gansu
Gansu Province Medical Science Institute Active, not recruiting
Lanzhou, Gansu, China, 730050
China, Guangxi
Guangxi Tumor Hospital Active, not recruiting
Nanning, Guangxi, China, 530021
China, Guizhou
GuiZhou Cancer Hospital Active, not recruiting
Guiyang, Guizhou, China, 550004
China, Neimenggu
Neimenggu Tumor Hospital Active, not recruiting
Baotou, Neimenggu, China, 014030
China, Ningxia
The Tumor Affiliated Hospital of Ningxia Medical University General Hospita Active, not recruiting
Yinchuan, Ningxia, China, 750004
China, Qinghai
Qinghai Five Hospital Active, not recruiting
Xining, Qinghai, China
China, Shanxi
Xijing Hospital Active, not recruiting
Xi-an, Shanxi, China, 710032
ShanXi Cancer Hospital Active, not recruiting
Xian, Shanxi, China, 710061
China, Sichuan
The Second People's Hospital of Sichuan Recruiting
Chengdu, Sichuan, China, 610041
Contact: Peng Xu, M.D.    15828312322    xupeng4618@163.com   
West China Hospital, Sichuan University Active, not recruiting
Chengdu, Sichuan, China, 610041
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University Active, not recruiting
Chongqing, Sichuan, China, 400042
China, Xinjiang
Xinjiang tumor hospital, The Third Affiliated Hospital of Xinjiang Medical University Active, not recruiting
Wulumuqi, Xinjiang, China, 830000
China, Yunnan
Yunnan Tumor Hospital, The Third Affiliated Hospital of KUNMING Medical University Active, not recruiting
Kunming, Yunnan, China, 652100
Sponsors and Collaborators
The Second People's Hospital of Sichuan
Biotech Pharmaceutical Co., Ltd.
Investigators
Principal Investigator: Yi J Lang, M.D. Radiotherapy department
  More Information

No publications provided

Responsible Party: LANG Jin-yi, Professor of radiotherapy department, The Second People's Hospital of Sichuan
ClinicalTrials.gov Identifier: NCT01516996     History of Changes
Other Study ID Numbers: BT-IST-SCCHN-036
Study First Received: January 11, 2012
Last Updated: March 18, 2012
Health Authority: China: Food and Drug Administration

Keywords provided by The Second People's Hospital of Sichuan:
Neoadjuvant
Concurrent Chemoradiotherapy,CCRT
Nimotuzumab
Locoregionally Advanced Oropharynx
Hypopharynx cancer
Randomized
Multicenter

Additional relevant MeSH terms:
Hypopharyngeal Neoplasms
Oropharyngeal Neoplasms
Head and Neck Neoplasms
Neoplasms
Neoplasms by Site
Otorhinolaryngologic Diseases
Otorhinolaryngologic Neoplasms
Pharyngeal Diseases
Pharyngeal Neoplasms
Stomatognathic Diseases
Cisplatin
Docetaxel
Antimitotic Agents
Antineoplastic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Radiation-Sensitizing Agents
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on October 22, 2014