NCT03243825

Brief Summary

For stage Ib2-IIa2 cervical cancer patients, neoadjuvant therapy followed by radical hysterectomy and pelvic lymphadenectomy is one of the managements. Post-operative concurrent chemo-radiotherapy is necessary if the patients have high-risk factors, including positive surgical margin, parametrium and pelvic nodes. Our previous retrospective study showed that combination of neoadjuvant chemotherapy and brachytherapy reduced the proportion of post-operative concurrent chemo-radiotherapy compared to neoadjuvant chemotherapy alone.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

November 1, 2012

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

July 27, 2014

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
2.1 years until next milestone

First Posted

Study publicly available on registry

August 9, 2017

Completed
Last Updated

August 9, 2017

Status Verified

August 1, 2017

Enrollment Period

2.6 years

First QC Date

July 27, 2014

Last Update Submit

August 8, 2017

Conditions

Cervical Cancer

Keywords

neoadjuvant chemotherapybrachytherapyradiotherapy

Outcome Measures

Primary Outcomes (1)

  • proportion of post-operative chemo-radiotherapy

    2 months

Secondary Outcomes (1)

  • 3-year disease-free survival

    3 years

Study Arms (2)

chemo/brachytherapy

EXPERIMENTAL

Patients in this arm will receive neoadjuvant chemotherapy (paclitaxel/cisplatinum) and brachytherapy before radical hysterectomy.

Radiation: combination group

chemotherapy

ACTIVE COMPARATOR

Patients in this arm will receive neoadjuvant chemotherapy (paclitaxel/cisplatinum) before radical hysterectomy.

Drug: chemotherapy group

Interventions

combination groupRADIATION

chemotherapy (paclitaxel/cisplatinum) and brachytherapy

chemo/brachytherapy
chemotherapy groupDRUG

chemotherapy: (paclitaxel/cisplatinum)

chemotherapy

Eligibility Criteria

Age25 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histology confirmed cervical cancer
  • Clinical stage Ib2 or IIa2 (FIGO 2009)

You may not qualify if:

  • Patients who not suitable for surgery
  • Personal history of pelvic radiotherapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cancer Hospital, Chinese Acadamy of Medical Sceinces

Beijing, 100021, China

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

  • Ning Li, MD

    Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

July 27, 2014

First Posted

August 9, 2017

Study Start

November 1, 2012

Primary Completion

June 1, 2015

Study Completion

July 1, 2015

Last Updated

August 9, 2017

Record last verified: 2017-08

Locations

CN(1)