NCT03469531

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Mar 2018

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 28, 2018

Completed
19 days until next milestone

First Posted

Study publicly available on registry

March 19, 2018

Completed
1 day until next milestone

Study Start

First participant enrolled

March 20, 2018

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 10, 2021

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2021

Completed
Last Updated

August 13, 2018

Status Verified

February 1, 2018

Enrollment Period

3 years

First QC Date

February 28, 2018

Last Update Submit

August 9, 2018

Conditions

NeoplasmsCervical Adenosquamous Cell CarcinomaCervical Squamous Cell Carcinoma in SituStage IB Cervical CancerStage IIA Cervical CancerStage IIB Cervical CancerStage III Cervical CancerStage IVA Cervical Cancer

Keywords

Cervical CancerRadiation TherapyChemotherapyNimotuzumabCisplatin

Outcome Measures

Primary Outcomes (1)

  • progress free survival rate

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

    3 years

Secondary Outcomes (4)

  • Overall survival rate

    3 years

  • Local area control rate.

    3 years

  • No distant metastatic survival.

    3 years

  • objective response rate

    3 years

Study Arms (2)

experimental group

EXPERIMENTAL

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

Drug: NimotuzumabDrug: CisplatinRadiation: external-beam radiationRadiation: brachytherapy

control group

ACTIVE COMPARATOR

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

Drug: CisplatinRadiation: external-beam radiationRadiation: brachytherapy

Interventions

NimotuzumabDRUG

Patients receive nimotuzumab IV over 90 minutes on days 1, 8, 15, 22, 29, 36,43.

Also known as: EGFR monoclonal antibody
experimental group
CisplatinDRUG

Patients undergo cisplatin, 25-40 mg/m2 a week for 4 or 5weeks

Also known as: Cisplatin injection
control groupexperimental group
external-beam radiationRADIATION

Patients undergo pelvic EBRT once daily, 5 days a week, for 5 weeks for a total of 45-50.4Gy

Also known as: pelvic EBRT
control groupexperimental group
brachytherapyRADIATION

high-dose rate brachytherapy,6Gy once weekly,for a total of 24-30Gy

Also known as: high-dose rate brachytherapy
control groupexperimental group

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhujiang Hospital

Guangzhou, Guangdong, 510282, China

RECRUITING

MeSH Terms

Conditions

NeoplasmsUterine Cervical DysplasiaUterine Cervical Neoplasms

Interventions

nimotuzumabCisplatinBrachytherapy

Condition Hierarchy (Ancestors)

Precancerous ConditionsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesUterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by Site

Intervention Hierarchy (Ancestors)

Chlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsRadiotherapyTherapeutics

Study Officials

  • junguo bu, doctor

    Zhujiang Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

junguo bu, doctor

CONTACT

+86 13729810406bujunguo888@163.com

jiqiang li, doctor

CONTACT

+86 1363131720313631317203@163.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 28, 2018

First Posted

March 19, 2018

Study Start

March 20, 2018

Primary Completion

March 10, 2021

Study Completion

December 30, 2021

Last Updated

August 13, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)