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

Sponsor
Air Force Military Medical University, China (Other)
Overall Status
Unknown status
CT.gov ID
NCT02705612
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
36
Duration (Months)
1.7
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Efficacy and Safety of Radiotherapy Concurrently Combined With Cisplatin and Nimotuzumab for Patients With Locally Advanced Cervical Cancer
Study Start Date :
Sep 1, 2015
Anticipated Primary Completion Date :
Sep 1, 2016
Anticipated Study Completion Date :
Sep 1, 2018

Arms and Interventions

Arm Intervention/Treatment
Other: control group

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.

Drug: Cisplatin

Radiation: External Beam Radiation Therapy

Radiation: Internal Radiation Therapy
Experimental: experimental group

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

Drug: Cisplatin

Radiation: External Beam Radiation Therapy

Radiation: Internal Radiation Therapy

Drug: nimotuzumab

Outcome Measures

Primary Outcome Measures

  1. Overall survival rate [at 3 years]

    Described with Kaplan-Meier curves and unadjusted logrank tests.

  2. disease free survival rate [at 3 years]

  3. non-distant metastasis survival rate [at 3 years]

  4. survival period of non-progressive. [at 3 years]

Secondary Outcome Measures

  1. Quality of life [3 years]

  2. Radiation protocol compliance [3 years]

  3. Rate of acute and long-term toxicities [3 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Radiation Oncology, Xijing Hospital, Fourth Military Medical University Xi'an Shaanxi China 710032

Sponsors and Collaborators

  • Air Force Military Medical University, China

Investigators

  • Principal Investigator: Mei Shi, MD, department of radiation oncology

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mei Shi, Director and professor of Radiation Oncology，Xijing Hospital，Fourth Millitary Medical University, Air Force Military Medical University, China
ClinicalTrials.gov Identifier:
NCT02705612
Other Study ID Numbers:
  • XJFL-2016-02-LACC-Nimotuzumab
First Posted:
Mar 10, 2016
Last Update Posted:
Mar 10, 2016
Last Verified:
Mar 1, 2016
Keywords provided by Mei Shi, Director and professor of Radiation Oncology，Xijing Hospital，Fourth Millitary Medical University, Air Force Military Medical University, China
Cervical cancer
cisplatin
nimotuzumab
Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Nimotuzumab

Study Results

No Results Posted as of Mar 10, 2016