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Phase II Clinical Trial of Concurrent Chemoradiotherapy Combined Nimotuzumab for Stage IIB-IVA Cervical Cancer

Primary Purpose

Cervical Cancer

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Cisplatin

External Beam Radiation Therapy

Internal Radiation Therapy

nimotuzumab

About this trial

This is an interventional treatment trial for Cervical Cancer focused on measuring Cervical cancer, cisplatin, nimotuzumab

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

18 Years to 70 Years，female
Histological diagnosis of squamous cell carcinoma of cervix, FIGO stage IIB-IVA,with diameter 4-6 cm, without distant metastasis.
no chance of surgery confirmed by more than two deputy chief doctors of gynecology.
Moderate or high expression of EGFR
The function of main organ is normal, including blood, heart, lung, liver, and kidney. Without history of hypertension, stroke. Blood pressure is normal before treatment.
WBC≥3.5×10E9/L，ANC≥1.5×10E9/L；HB≥90g/L，PLT≥100×10E9/L
ALT, AST and Cr below 1.5 times of normal level
Willing to accept treatment
Ability to comply with trial requirements KPS≥70

Exclusion Criteria:

Evidence of distance metastasis
Impossible to measure the diameter of tumor, or the tumor is too huge (diameter>6cm)
Couldn't examine with pelvic MRI due to a variety of reasons
Used to treat with radiotherapy chemotherapy or molecular target therapy and immune therapy
Diagnosed with another malignant tumor in 5 years
Used to be a volunteer of other clinical trial.
Used to be allergic reaction with grade 3 or 4 degree to any experimental drugs
Severe medical history of lung ,liver, kidney or heart.
Active infection in any part of the whole body.
Examination results showed radiotherapy contraindications

Sites / Locations

Department of Radiation Oncology, Xijing Hospital, Fourth Military Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

control group

experimental group

Arm Description

Patients receive cisplatin IV over 60-90 minutes on days 1, 8, 15, 22, and 29. Patients also undergo external-beam radiation therapy once daily, 5 days a week, for approximately 5 weeks. Patients then undergo high-dose rate intracavitary brachytherapy.

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

Outcomes

Primary Outcome Measures

Overall survival rate

Described with Kaplan-Meier curves and unadjusted logrank tests.

disease free survival rate

non-distant metastasis survival rate

survival period of non-progressive.

Secondary Outcome Measures

Quality of life

Radiation protocol compliance

Rate of acute and long-term toxicities

Full Information

NCT ID

NCT02705612

First Posted

March 5, 2016

Last Updated

March 9, 2016

Sponsor

Air Force Military Medical University, China

1. Study Identification

Unique Protocol Identification Number

NCT02705612

Brief Title

Phase II Clinical Trial of Concurrent Chemoradiotherapy Combined Nimotuzumab for Stage IIB-IVA Cervical Cancer

Official Title

Efficacy and Safety of Radiotherapy Concurrently Combined With Cisplatin and Nimotuzumab for Patients With Locally Advanced Cervical Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

March 2016

Overall Recruitment Status

Unknown status

Study Start Date

September 2015 (undefined)

Primary Completion Date

September 2016 (Anticipated)

Study Completion Date

September 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Air Force Military Medical University, China

4. Oversight

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 injection combined with concurrent chemoradiotherapy for initially inoperable locally advanced cervical cancer.

Detailed Description

For locally advanced cervical cancer, radical radiation with concurrent chemotherapy remains the standard treatment recommended by NCCN. However, in more than 35% of cases, tumor persistence recurrence or metastasis would occur after chemoradiation. Nimotuzumab, belongs to anti-EGFR monoclonal antibodies, has proved to be useful in multiple solid tumors, such as NPC, colorectal cancer, etc. In recent years, nimotuzumab was also applied in recurrence or metastasis cervical cancer. It was proved to be well tolerated and might have a role in the treatment of advanced cervical cancer. However, there is no publication about nimotuzumab used in locally advanced cervical cancer.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cervical Cancer

Keywords

Cervical cancer, cisplatin, nimotuzumab

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

control group

Arm Type

Other

Arm Description

Arm Title

experimental group

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Cisplatin

Intervention Type

Radiation

Intervention Name(s)

External Beam Radiation Therapy

Intervention Type

Radiation

Intervention Name(s)

Internal Radiation Therapy

Intervention Type

Drug

Intervention Name(s)

nimotuzumab

Primary Outcome Measure Information:

Title

Overall survival rate

Description

Described with Kaplan-Meier curves and unadjusted logrank tests.

Time Frame

at 3 years

Title

disease free survival rate

Time Frame

at 3 years

Title

non-distant metastasis survival rate

Time Frame

at 3 years

Title

survival period of non-progressive.

Time Frame

at 3 years

Secondary Outcome Measure Information:

Title

Quality of life

Time Frame

3 years

Title

Radiation protocol compliance

Time Frame

3 years

Title

Rate of acute and long-term toxicities

Time Frame

3 years

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 18 Years to 70 Years，female Histological diagnosis of squamous cell carcinoma of cervix, FIGO stage IIB-IVA,with diameter 4-6 cm, without distant metastasis. no chance of surgery confirmed by more than two deputy chief doctors of gynecology. Moderate or high expression of EGFR The function of main organ is normal, including blood, heart, lung, liver, and kidney. Without history of hypertension, stroke. Blood pressure is normal before treatment. WBC≥3.5×10E9/L，ANC≥1.5×10E9/L；HB≥90g/L，PLT≥100×10E9/L ALT, AST and Cr below 1.5 times of normal level Willing to accept treatment Ability to comply with trial requirements KPS≥70 Exclusion Criteria: Evidence of distance metastasis Impossible to measure the diameter of tumor, or the tumor is too huge (diameter>6cm) Couldn't examine with pelvic MRI due to a variety of reasons Used to treat with radiotherapy chemotherapy or molecular target therapy and immune therapy Diagnosed with another malignant tumor in 5 years Used to be a volunteer of other clinical trial. Used to be allergic reaction with grade 3 or 4 degree to any experimental drugs Severe medical history of lung ,liver, kidney or heart. Active infection in any part of the whole body. Examination results showed radiotherapy contraindications

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Mei Shi, MD

Phone

0086-029-84775432

mshi82@fmmu.edu.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mei Shi, MD

Organizational Affiliation

department of radiation oncology

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Radiation Oncology, Xijing Hospital, Fourth Military Medical University

City

Xi'an

State/Province

Shaanxi

ZIP/Postal Code

710032

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Mei Shi, MD

Phone

+86-029-84775425

mshifmmu@yahoo.com

First Name & Middle Initial & Last Name & Degree

Mei Shi, MD

First Name & Middle Initial & Last Name & Degree

Li-Chun Wei, M.D.,Ph.D

12. IPD Sharing Statement

Learn more about this trial

Phase II Clinical Trial of Concurrent Chemoradiotherapy Combined Nimotuzumab for Stage IIB-IVA Cervical Cancer

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