NCT03175848

Brief Summary

This is a prospective, single arm, phase II trail to assess the effect of primary lesion radiotherapy in the treatment of stage IVB cervical cancer on the basis of systemic chemotherapy.

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
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2017

Longer than P75 for not_applicable

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

Study Start

First participant enrolled

May 5, 2017

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

May 28, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 5, 2017

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2018

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2020

Completed
Last Updated

July 21, 2017

Status Verified

May 1, 2017

Enrollment Period

1.5 years

First QC Date

May 28, 2017

Last Update Submit

July 18, 2017

Conditions

Cervical Cancer Stage IVB

Keywords

Cervical CancerRadiotherapyChemotherapystage IVB cervical cancer

Outcome Measures

Primary Outcomes (1)

  • Progression-free survival time, PFS

    Progression-free survival will be evaluated

    2 years

Secondary Outcomes (5)

  • Number of Patients with Adverse Events as a Measure of Safety

    2 years

  • Objective Response Rates, ORR

    2 years

  • Overall survival

    2 years

  • Ranking Quality of Life of Patients

    2 years

  • Screening for potentially curable primary stage IVB cervical cancer

    2 years

Study Arms (1)

Chemotherapy,radiotherapy

EXPERIMENTAL

Lymphatic metastasis patients undergoing 2 cycles of chemotherapy(TP/TC), blood metastasis patients receiving 4 cycles of chemotherapy, then patients with therapeutic evaluation for (CR+PR+SD) will undergo the radiotherapy (external irradiation plus brachytherapy) for primary lesion area , all patients completed total 6 cycles of chemotherapy (TP/TC), and finally will determine the of treatment plans of metastasis areas based on tolerance and discuss results by MDT.

Radiation: Chemotherapy,radiotherapy

Interventions

Chemotherapy,radiotherapyRADIATION

Pelvic,pelvic-inguinal,or extended field radiotherapy：Therapy 45 - 50 Gy in 1.7 - 2.0 Gy daily fractions over 4.5 - 5.5 weeks for PTV Brachytherapy: Therapy 5-6 fractions of 4-6Gy prescribed to the high-risk CTV or A piont.

Chemotherapy,radiotherapy

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsAdult female cervical cancer patients
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Biopsy-proven, invasive carcinoma of the cervix(squamous cell carcinoma, adenocarcinoma and adenosquamous carcinoma )
  • KPS≥70
  • FIGO stage IVB
  • Age: 18-70
  • ECOG (Eastern Cooperative Oncology Group) : 0-2
  • The expected survival time is \>6 months
  • Chemotherapy and radiation have not been done before
  • Normal hemodynamic indices before the recruitment (including white blood cell count\>4.0×109/L, neutrophil count\>1.5×109/L, platelet count \>100×109/L, hemoglobin≥90g/l, normal liver/kidney function)
  • Able to understand this study and have signed informed consent.

You may not qualify if:

  • Prior hysterectomy
  • Metastases lesions are confirmed by pathology or image and are excluded as the second primary neoplasm
  • Patients with brain metastasis or disseminated peritoneal metastasis
  • Female in pregnancy or lactating
  • Hypersensitivity of chemotherapeutic drugs (paclitaxel allergy)
  • History of major psychiatric disorder
  • Persons with physical or mental illness, without civil capacity or with limited capacity for civil conduct
  • Patient with any other disease or condition is a contraindication for chemoradiotherapy
  • The researchers consider the patient not appropriate to be enrolled

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

RECRUITING

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Drug TherapyRadiotherapy

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • HanMei Lou, M.A.

    Zhejiang Cancer Hospital

    PRINCIPAL INVESTIGATOR

  • ZhuoMin Yin

    Zhejiang Cancer Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

HanMei Lou, M.A.

CONTACT

Telephone: 0086-571-88122038louhanmei@zjcc.org.cn

ZhuoMin Yin

CONTACT

0086-571-88122032yinzm@zjcc.org.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 28, 2017

First Posted

June 5, 2017

Study Start

May 5, 2017

Primary Completion

October 31, 2018

Study Completion

October 31, 2020

Last Updated

July 21, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)