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

Primary Purpose

Neoplasms, Cervical Adenosquamous Cell Carcinoma, Cervical Squamous Cell Carcinoma in Situ

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Nimotuzumab
Cisplatin
external-beam radiation
brachytherapy
Sponsored by
Zhujiang Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neoplasms focused on measuring Cervical Cancer, Radiation Therapy, Chemotherapy, Nimotuzumab, Cisplatin

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Zhujiang HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

experimental group

control group

Arm Description

Patients receive nimotuzumab combined with cisplatin and undergo external-beam radiation and brachytherapy as the patients in experimental group.

Patients receive cisplatin and undergo external-beam radiation and brachytherapy as the patients in control group.

Outcomes

Primary Outcome Measures

progress free survival rate
The rate of patient without progress disease in 3 years after treatment

Secondary Outcome Measures

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

Full Information

First Posted
February 28, 2018
Last Updated
August 9, 2018
Sponsor
Zhujiang Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03469531
Brief Title
Study of Nimotuzumab Combined With Concurrent Chemoradiotherapy for Locally Advanced Cervical Cancer
Official Title
Efficacy and Safety of Nimotuzumab Combined With Radiotherapy and Concurrently Cisplatin in Patients With Stage IIB-IVA Cervical Squamous Cell Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Unknown status
Study Start Date
March 20, 2018 (Actual)
Primary Completion Date
March 10, 2021 (Anticipated)
Study Completion Date
December 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zhujiang Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neoplasms, Cervical Adenosquamous Cell Carcinoma, Cervical Squamous Cell Carcinoma in Situ, Stage IB Cervical Cancer, Stage IIA Cervical Cancer, Stage IIB Cervical Cancer, Stage III Cervical Cancer, Stage IVA Cervical Cancer
Keywords
Cervical Cancer, Radiation Therapy, Chemotherapy, Nimotuzumab, Cisplatin

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
experimental group
Arm Type
Experimental
Arm Description
Patients receive nimotuzumab combined with cisplatin and undergo external-beam radiation and brachytherapy as the patients in experimental group.
Arm Title
control group
Arm Type
Active Comparator
Arm Description
Patients receive cisplatin and undergo external-beam radiation and brachytherapy as the patients in control group.
Intervention Type
Drug
Intervention Name(s)
Nimotuzumab
Other Intervention Name(s)
EGFR monoclonal antibody
Intervention Description
Patients receive nimotuzumab IV over 90 minutes on days 1, 8, 15, 22, 29, 36,43.
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Other Intervention Name(s)
Cisplatin injection
Intervention Description
Patients undergo cisplatin, 25-40 mg/m2 a week for 4 or 5weeks
Intervention Type
Radiation
Intervention Name(s)
external-beam radiation
Other Intervention Name(s)
pelvic EBRT
Intervention Description
Patients undergo pelvic EBRT once daily, 5 days a week, for 5 weeks for a total of 45-50.4Gy
Intervention Type
Radiation
Intervention Name(s)
brachytherapy
Other Intervention Name(s)
high-dose rate brachytherapy
Intervention Description
high-dose rate brachytherapy,6Gy once weekly,for a total of 24-30Gy
Primary Outcome Measure Information:
Title
progress free survival rate
Description
The rate of patient without progress disease in 3 years after treatment
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Overall survival rate
Description
The rate of patient alive in 3 years after treatment
Time Frame
3 years
Title
Local area control rate.
Description
The rate of patient without recurrence in 3 years after treatment
Time Frame
3 years
Title
No distant metastatic survival.
Description
The rate of patient without metastatic disease in 3 years after treatment
Time Frame
3 years
Title
objective response rate
Description
the percentage of patients who experienced complete or partial cancer shrinkage or disappearance after treatment.
Time Frame
3 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
junguo bu, doctor
Phone
+86 13729810406
Email
bujunguo888@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
jiqiang li, doctor
Phone
+86 13631317203
Email
13631317203@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
junguo bu, doctor
Organizational Affiliation
Zhujiang Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zhujiang Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510282
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
junguo bu, MD
Phone
13729810406
Email
ljq821028@126.com
First Name & Middle Initial & Last Name & Degree
jiqiang li, MD
Phone
13631317203
Email
13631317203@163.com

12. IPD Sharing Statement

Plan to Share IPD
No

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

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