Study of Nimotuzumab Combined With Concurrent Chemoradiotherapy for Locally Advanced Cervical Cancer

August 9, 2018 updated by: Zhujiang Hospital

Efficacy and Safety of Nimotuzumab Combined With Radiotherapy and Concurrently Cisplatin in Patients With Stage IIB-IVA Cervical Squamous Cell Carcinoma

The purpose of this phase II trial is to determine the feasibility and efficacy of nimotuzumab combined with concurrent chemoradiotherapy for initially inoperable locally advanced cervical squamous cell carcinoma.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

This phase II trial is studying how well giving nimotuzumab together with radiation therapy and cisplatin works in treating patients with previously untreated locally advanced cervical cancer. Monoclonal antibodies, such as nimotuzumab, a humanized anti-epidermal growth factor receptor (EGFR) monoclonal antibody that is approved in many countries for the treatment of EGFR-positive cancers. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Nimotuzumab also stop the growth of cervical cancer by increasing the effect of chemotherapy. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving nimotuzumab together with radiation therapy and cisplatin may kill more tumor cells.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • 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
    • Guangdong
      • Guangzhou, Guangdong, China, 510282
        • Recruiting
        • Zhujiang Hospital
        • Contact:
        • Contact:

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

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • All volunteers will sign the informed consent.
  • Histologically confirmed squamous cell of the uterine cervix, EGFR(+).
  • The FIGO stage (IIB-IVA) and was not available for surgical treatment.
  • There is at least one tumor lesion that is measurable by RECIST.
  • During the study, contraception should be ensured.
  • Karnofsky performance status >60.
  • WBC >= 3,000/mm^3
  • Absolute granulocyte count >= 1,500/mm^3
  • Platelet count >= 100,000/mm^3
  • INR < 1.5
  • Total bilirubin =< 1.5 mg/dL
  • Serum creatinine =< 1.5 mg/dL
  • AST and ALT =< 2.5 times upper limit of normal (ULN)
  • Serum calcium =< 1.3 times ULN
  • Hemoglobin >= 9g/dL (transfusion allowed)

Exclusion Criteria:

  • Positive para-aortic lymph nodes or positive lymph nodes beyond pelvic
  • Prior invasive malignancy (except nonmelanomatous skin cancer)
  • Contraindication of chemotherapy;
  • Rare pathological subtype;
  • Cervical cancer patients underwent hysterectomy, laparoscopic surgery or systemic chemotherapy.

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
Intervention / Treatment
Experimental: experimental group
Patients receive nimotuzumab combined with cisplatin and undergo external-beam radiation and brachytherapy as the patients in experimental group.
Drug: Nimotuzumab
Patients receive nimotuzumab IV over 90 minutes on days 1, 8, 15, 22, 29, 36,43.
Other Names:
  • EGFR monoclonal antibody
Drug: Cisplatin
Patients undergo cisplatin, 25-40 mg/m2 a week for 4 or 5weeks
Other Names:
  • Cisplatin injection
Radiation: external-beam radiation
Patients undergo pelvic EBRT once daily, 5 days a week, for 5 weeks for a total of 45-50.4Gy
Other Names:
  • pelvic EBRT
Radiation: brachytherapy
high-dose rate brachytherapy,6Gy once weekly,for a total of 24-30Gy
Other Names:
  • high-dose rate brachytherapy
Active Comparator: control group
Patients receive cisplatin and undergo external-beam radiation and brachytherapy as the patients in control group.
Drug: Cisplatin
Patients undergo cisplatin, 25-40 mg/m2 a week for 4 or 5weeks
Other Names:
  • Cisplatin injection
Radiation: external-beam radiation
Patients undergo pelvic EBRT once daily, 5 days a week, for 5 weeks for a total of 45-50.4Gy
Other Names:
  • pelvic EBRT
Radiation: brachytherapy
high-dose rate brachytherapy,6Gy once weekly,for a total of 24-30Gy
Other Names:
  • high-dose rate brachytherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
progress free survival rate
Time Frame: 3 years
The rate of patient without progress disease in 3 years after treatment
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival rate
Time Frame: 3 years
The rate of patient alive in 3 years after treatment
3 years
Local area control rate.
Time Frame: 3 years
The rate of patient without recurrence in 3 years after treatment
3 years
No distant metastatic survival.
Time Frame: 3 years
The rate of patient without metastatic disease in 3 years after treatment
3 years
objective response rate
Time Frame: 3 years
the percentage of patients who experienced complete or partial cancer shrinkage or disappearance after treatment.
3 years

Collaborators and Investigators

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

Sponsor

Zhujiang Hospital

Investigators

  • Principal Investigator: junguo bu, doctor, Zhujiang Hospital

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 (Actual)

March 20, 2018

Primary Completion (Anticipated)

March 10, 2021

Study Completion (Anticipated)

December 30, 2021

Study Registration Dates

First Submitted

February 28, 2018

First Submitted That Met QC Criteria

March 16, 2018

First Posted (Actual)

March 19, 2018

Study Record Updates

Last Update Posted (Actual)

August 13, 2018

Last Update Submitted That Met QC Criteria

August 9, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017-ZLZX-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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