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

Primary Purpose

Oropharyngeal Cancer, Hypopharyngeal Cancer

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
docetaxel and cisplatin
IMRT
Nimotuzumab
Sponsored by
The Second People's Hospital of Sichuan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Oropharyngeal Cancer focused on measuring Neoadjuvant, Concurrent Chemoradiotherapy,CCRT, Nimotuzumab, Locoregionally Advanced Oropharynx, Hypopharynx cancer, Randomized, Multicenter

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Gansu Province Medical Science Institute
  • Guangxi Tumor Hospital
  • GuiZhou Cancer Hospital
  • Neimenggu Tumor Hospital
  • The Tumor Affiliated Hospital of Ningxia Medical University General Hospita
  • Qinghai Five Hospital
  • Xijing Hospital
  • ShanXi Cancer Hospital
  • The Second People's Hospital of SichuanRecruiting
  • West China Hospital, Sichuan University
  • Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
  • Xinjiang tumor hospital, The Third Affiliated Hospital of Xinjiang Medical University
  • Yunnan Tumor Hospital, The Third Affiliated Hospital of KUNMING Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Neoadjuvant and CCRT

Neoadjuvant and CCRT and Nimotuzumab

Arm Description

Outcomes

Primary Outcome Measures

Objective response rate
Objective Response Rate: Complete response (CR)+ partial response (PR) rates base on RECIST evaluation system.
The Number of Participants with Adverse Events
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
Progression-Free Survival
Evaluate the Local control Rate in 1 to 5 years.
To evaluate each year until 5 years later
Tumor-Free Survival
Non-metastatic Rate

Full Information

First Posted
January 11, 2012
Last Updated
March 18, 2012
Sponsor
The Second People's Hospital of Sichuan
Collaborators
Biotech Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT01516996
Brief Title
Safety and Efficacy Study of Nimotuzumab Plus Neoadjuvant and Concurrent Chemoradiotherapy to Treat Oropharynx and Hypopharynx Cancer
Official Title
Neoadjuvant and Concurrent Chemoradiotherapy Plus Nimotuzumab in Treating Patients With Locoregionally Advanced Squamous Cell Carcinoma of the Oropharynx and Hypopharynx
Study Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Unknown status
Study Start Date
March 2012 (undefined)
Primary Completion Date
September 2013 (Anticipated)
Study Completion Date
March 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Second People's Hospital of Sichuan
Collaborators
Biotech Pharmaceutical Co., Ltd.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oropharyngeal Cancer, Hypopharyngeal Cancer
Keywords
Neoadjuvant, Concurrent Chemoradiotherapy,CCRT, Nimotuzumab, Locoregionally Advanced Oropharynx, Hypopharynx cancer, Randomized, Multicenter

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Neoadjuvant and CCRT
Arm Type
Active Comparator
Arm Title
Neoadjuvant and CCRT and Nimotuzumab
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
docetaxel and cisplatin
Intervention Description
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
Radiation
Intervention Name(s)
IMRT
Other Intervention Name(s)
CCRT
Intervention Description
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
Biological
Intervention Name(s)
Nimotuzumab
Intervention Description
Nimotuzumab was administered 200 mg IV over 1 hour on day 1,once a week, for 13~14 weeks
Primary Outcome Measure Information:
Title
Objective response rate
Description
Objective Response Rate: Complete response (CR)+ partial response (PR) rates base on RECIST evaluation system.
Time Frame
3 months after all the treatment ending
Title
The Number of Participants with Adverse Events
Description
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.
Time Frame
Participants will be followed during the treatment and 3 months after all the treatment ending ,an expected average of 26 weeks
Secondary Outcome Measure Information:
Title
Overall Survival
Time Frame
From date of randomization until the date of death from any cause,assessed up to 5 years
Title
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
Title
Evaluate the Local control Rate in 1 to 5 years.
Description
To evaluate each year until 5 years later
Time Frame
Participants will be followed every year for the duration of 5 years
Title
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
Title
Non-metastatic Rate
Time Frame
The time from randomization until distant relapse occur,assessed up to 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yi J Lang, M.D.
Organizational Affiliation
Radiotherapy department
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gansu Province Medical Science Institute
City
Lanzhou
State/Province
Gansu
ZIP/Postal Code
730050
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Guangxi Tumor Hospital
City
Nanning
State/Province
Guangxi
ZIP/Postal Code
530021
Country
China
Individual Site Status
Active, not recruiting
Facility Name
GuiZhou Cancer Hospital
City
Guiyang
State/Province
Guizhou
ZIP/Postal Code
550004
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Neimenggu Tumor Hospital
City
Baotou
State/Province
Neimenggu
ZIP/Postal Code
014030
Country
China
Individual Site Status
Active, not recruiting
Facility Name
The Tumor Affiliated Hospital of Ningxia Medical University General Hospita
City
Yinchuan
State/Province
Ningxia
ZIP/Postal Code
750004
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Qinghai Five Hospital
City
Xining
State/Province
Qinghai
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Xijing Hospital
City
Xi-an
State/Province
Shanxi
ZIP/Postal Code
710032
Country
China
Individual Site Status
Active, not recruiting
Facility Name
ShanXi Cancer Hospital
City
Xian
State/Province
Shanxi
ZIP/Postal Code
710061
Country
China
Individual Site Status
Active, not recruiting
Facility Name
The Second People's Hospital of Sichuan
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peng Xu, M.D.
Phone
15828312322
Email
xupeng4618@163.com
Facility Name
West China Hospital, Sichuan University
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
City
Chongqing
State/Province
Sichuan
ZIP/Postal Code
400042
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Xinjiang tumor hospital, The Third Affiliated Hospital of Xinjiang Medical University
City
Wulumuqi
State/Province
Xinjiang
ZIP/Postal Code
830000
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Yunnan Tumor Hospital, The Third Affiliated Hospital of KUNMING Medical University
City
Kunming
State/Province
Yunnan
ZIP/Postal Code
652100
Country
China
Individual Site Status
Active, not recruiting

12. IPD Sharing Statement

Learn more about this trial

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

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