NCT01755845

Brief Summary

The purpose of this study is to determine the efficacy and safety of consolidation chemotherapy with paclitaxel plus cisplatin (2 cycles per 3 weeks) following radical hysterectomy and adjuvant chemoradiation (2 cycles per 4 weeks) for high risk early stage cervical cancer.

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
300

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jan 2011

Longer than P75 for phase_3

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

January 1, 2011

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

December 19, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 24, 2012

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

April 28, 2016

Status Verified

April 1, 2016

Enrollment Period

5.9 years

First QC Date

December 19, 2012

Last Update Submit

April 27, 2016

Conditions

Cervical Cancer

Keywords

cervical cancerradiotherapypostoperative therapychemotherapy

Outcome Measures

Primary Outcomes (1)

  • disease-free survival

    3 years

Secondary Outcomes (1)

  • overall survival

    5 years

Other Outcomes (1)

  • Number of participants with adverse events as a measure of safety and tolerability

    1 year

Study Arms (2)

Arm 1

EXPERIMENTAL

Patients in this arm will postoperatively receive paclitaxel 135 mg/m2 d1 and cisplatin 25mg/m2 d1-3 intravenously every 4 weeks with radiation. Radiotherapy consisted of 46-50 gray (5 x 2.0 gray/week) on pelvic area. After completion of chemoradiotherapy, patients receive paclitaxel 135 mg/m2 d1 and cisplatin 25mg/m2 d1-3. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.

Drug: paclitaxelDrug: cisplatinRadiation: radiotherapy

Arm 2

ACTIVE COMPARATOR

Patients receive chemoradiotherapy as in arm 1.

Drug: paclitaxelDrug: cisplatinRadiation: radiotherapy

Interventions

paclitaxelDRUG
Arm 1Arm 2
cisplatinDRUG
Arm 1Arm 2
radiotherapyRADIATION
Arm 1Arm 2

Eligibility Criteria

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

You may qualify if:

  • Undertaken radical hysterectomy with diagnosis of invasive cervical cancer I a2-II b (non-small cell type)
  • One or more risk factors (lymph node involvement, resection margin involvement, parametrial involvement)
  • Eastern Cooperative Oncology Group 0-2
  • Expected life span over 6 months.
  • No distant metastasis
  • Adequate bone marrow functions (absolute neutrophil count≥ 1,500/ul, blood platelet≥ 100,000/ul, haemoglobin≥ 10g/dl)
  • Adequate renal functions(serum creatinine ≤ 1.5mg/dl)
  • Adequate liver functions (serum bilirubin ≤ 1.5mg/dl, aspartate aminotransferase/alanine aminotransferase ≤ 3 times(normal value)
  • Written informed consent

You may not qualify if:

  • Previous history of chemotherapy or radiation
  • Hypersensitive reaction to platinum/paclitaxel agent
  • History of other cancer
  • Concurrent systemic illness not appropriate for chemotherapy
  • Active infection requiring antibiotics
  • Pregnancy
  • Metastasis to paraaortic lymph node

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Wenzhou Medical College

Wenzhou, Zhejiang, 325000, China

RECRUITING

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

PaclitaxelCisplatinRadiotherapy

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)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsTherapeutics

Central Study Contacts

congying xie, MD

CONTACT

+86-577-88069316wzxiecongying@163.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

December 19, 2012

First Posted

December 24, 2012

Study Start

January 1, 2011

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

April 28, 2016

Record last verified: 2016-04

Locations

CN(1)