NCT02490748

Brief Summary

The purpose of this study is to determine whether combining of radiofrequency ablation (RFA) and cytokine-induced killer cells (CIK) transfusion can prolong survival of patients with cervical cancer.

Trial Health

83
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for phase_2

Timeline
170mo left

Started Jul 2015

Longer than P75 for phase_2

Status
active not recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress44%
Jul 2015Jun 2040

Study Start

First participant enrolled

July 1, 2015

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

July 2, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 7, 2015

Completed
22.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2038

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2040

Last Updated

February 23, 2016

Status Verified

February 1, 2016

Enrollment Period

22.9 years

First QC Date

July 2, 2015

Last Update Submit

February 21, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • Recurrence-free survival

    Recurrence-free survival (RFS) was defined as the time from the date of RFA to the date of recurrence or the date of the last follow-up.

    1 year

Study Arms (2)

RFA alone

NO INTERVENTION

Patients undergo radiofrequency ablation alone.

RFA+CIK

EXPERIMENTAL

Autologous cytokine-induced killer cells were transfer via venous one week after RFA Interventions

Procedure: Radiofrequency ablationBiological: Cytokine-induced killer cells

Interventions

Radiofrequency ablation is performed percutaneously under CT/US guidance

Also known as: RFA
RFA+CIK

The patients received autologous cytokine-induced killer cells transfusion one week after RFA treatment.

Also known as: CIK
RFA+CIK

Eligibility Criteria

Age30 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • They were systematic reviews based on randomized controlled trials (rcts). They were phase II rcts comparing chemotherapy with other systemic therapy agents or with no further treatment for recurrent, metastatic, or persistent cervical cancer.
  • they reported at least one of these outcomes: complete or partial response rate, overall or progression-free survival rate, adverse effects, or healthrelated quality of life (rcts reporting on heterogeneous populations-for example, women at a range of disease stages-were included if results were given separately for patients with recurrent, metastatic, or persistent cervical cancer).

You may not qualify if:

  • studies evaluating the role of radiotherapy administered with chemotherapy, or second- or subsequent-line therapy options.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Radiofrequency Ablation

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)

Radiofrequency TherapyTherapeuticsAblation TechniquesSurgical Procedures, Operative

Study Design

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

Study Record Dates

First Submitted

July 2, 2015

First Posted

July 7, 2015

Study Start

July 1, 2015

Primary Completion (Estimated)

June 1, 2038

Study Completion (Estimated)

June 1, 2040

Last Updated

February 23, 2016

Record last verified: 2016-02