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

NCT02705612 | Unknown Phase 2 DMC

• 1 other identifier: XJFL-2016-02-LACC-Nimotuzumab
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Cancer

Keywords

Cervical cancer; cisplatin; nimotuzumab

Outcome Measures

Primary Outcomes (4)

• Overall survival rate

  Described with Kaplan-Meier curves and unadjusted logrank tests.

  at 3 years

• disease free survival rate

  at 3 years

• non-distant metastasis survival rate

  at 3 years

• survival period of non-progressive.

  at 3 years

Secondary Outcomes (3)

• Quality of life

  3 years

• Radiation protocol compliance

  3 years

• Rate of acute and long-term toxicities

  3 years

Study Arms (2)

control group

OTHER

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 group

EXPERIMENTAL

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

Interventions

Cisplatin DRUG

control group; experimental group

External Beam Radiation Therapy RADIATION

control group; experimental group

Internal Radiation Therapy RADIATION

control group; experimental group

nimotuzumab DRUG

experimental group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Air Force Military Medical University, China: lead

Study Sites (1)

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

Xi'an, Shaanxi, 710032, China

RECRUITING

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Cisplatin; Brachytherapy; nimotuzumab

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Radiotherapy; Therapeutics

Study Officials

• Mei Shi, MD

  department of radiation oncology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mei Shi, MD

CONTACT

0086-029-84775432; mshi82@fmmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director and professor of Radiation Oncology，Xijing Hospital，Fourth Millitary Medical University

Study Record Dates

• First Submitted: March 5, 2016
• First Posted: March 10, 2016
• Study Start: September 1, 2015
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2018
• Last Updated: March 10, 2016

Record last verified: 2016-03

Locations

CN (1)