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

March 18, 2012 updated by: LANG Jin-yi, The Second People's Hospital of Sichuan

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Gansu
      • Lanzhou, Gansu, China, 730050
        • Active, not recruiting
        • Gansu Province Medical Science Institute
    • Guangxi
      • Nanning, Guangxi, China, 530021
        • Active, not recruiting
        • Guangxi Tumor Hospital
    • Guizhou
      • Guiyang, Guizhou, China, 550004
        • Active, not recruiting
        • Guizhou Cancer Hospital
    • Neimenggu
      • Baotou, Neimenggu, China, 014030
        • Active, not recruiting
        • Neimenggu Tumor Hospital
    • Ningxia
      • Yinchuan, Ningxia, China, 750004
        • Active, not recruiting
        • The Tumor Affiliated Hospital of Ningxia Medical University General Hospita
    • Qinghai
      • Xining, Qinghai, China
        • Active, not recruiting
        • Qinghai Five Hospital
    • Shanxi
      • Xi-an, Shanxi, China, 710032
        • Active, not recruiting
        • Xijing Hospital
      • Xian, Shanxi, China, 710061
        • Active, not recruiting
        • Shanxi Cancer Hospital
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Active, not recruiting
        • West China Hospital, Sichuan University
      • Chengdu, Sichuan, China, 610041
        • Recruiting
        • The Second People's Hospital of Sichuan
        • Contact:
      • Chongqing, Sichuan, China, 400042
        • Active, not recruiting
        • Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
    • Xinjiang
      • Wulumuqi, Xinjiang, China, 830000
        • Active, not recruiting
        • Xinjiang tumor hospital, The Third Affiliated Hospital of Xinjiang Medical University
    • Yunnan
      • Kunming, Yunnan, China, 652100
        • Active, not recruiting
        • Yunnan Tumor Hospital, The Third Affiliated Hospital of KUNMING Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 Names:
  • 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 Names:
  • CCRT
Biological: Nimotuzumab
Nimotuzumab was administered 200 mg IV over 1 hour on day 1,once a week, for 13~14 weeks

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Objective response rate
Time Frame: 3 months after all the treatment ending
Objective Response Rate: Complete response (CR)+ partial response (PR) rates base on RECIST evaluation system.
3 months after all the treatment ending
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
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.
Participants will be followed during the treatment and 3 months after all the treatment ending ,an expected average of 26 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Overall Survival
Time Frame: From date of randomization until the date of death from any cause,assessed up to 5 years
From date of randomization until the date of death from any cause,assessed up to 5 years
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
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
Evaluate the Local control Rate in 1 to 5 years.
Time Frame: Participants will be followed every year for the duration of 5 years
To evaluate each year until 5 years later
Participants will be followed every year for the duration of 5 years
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
From date of randomization until the date of first documented occurrence of primary, neck, distant relapse,assessed up to 5 years
Non-metastatic Rate
Time Frame: The time from randomization until distant relapse occur,assessed up to 5 years
The time from randomization until distant relapse occur,assessed up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Second People's Hospital of Sichuan

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Biotech Pharmaceutical Co., Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Yi J Lang, M.D., Radiotherapy Department

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2012

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2013

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 11, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 20, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 25, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 20, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 18, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BT-IST-SCCHN-036

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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