NCT00846508

Brief Summary

This phase III study is designed to examine if low-risk, as defined by clinical and radiological parameters, stage IB-IIB cervical cancer patients treated by cisplatin-based chemoradiation, which is a recommended method by today's standard, have greater toxicities but similar survival rate as those treated by radiotherapy (RT) alone. Patients will be primarily treated with radiotherapy with same protocol, but without concurrent chemotherapy in the control arm, and with weekly cisplatin (40 mg/M2) for 6 courses in the study arm. This study will be conducted at all branches of Chang Gung Memorial Hospital except Chia-I. Patients will be randomized to either arm after stratification of risk factors. Each arm will recruit 104 patients who have no LN and systemic metastasis as defined by CT/MRI and FDG-PET. The primary end point is grade 3-5 late toxicities, and secondary end points are 1) recurrence free survival; 2) acute toxicity of treatments; 3) sites of recurrence; 4) quality of life; 5) total treatment time. It is expected to take 5 years to recruit enough case number.

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
208

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Feb 2009

Typical duration for phase_3

Geographic Reach
1 country

2 active sites

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

February 1, 2009

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

February 11, 2009

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 18, 2009

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

January 5, 2010

Status Verified

February 1, 2009

Enrollment Period

2.9 years

First QC Date

February 11, 2009

Last Update Submit

December 31, 2009

Conditions

Cervical Cancer

Keywords

cervical cancerCisplatinchemoradiation

Outcome Measures

Primary Outcomes (1)

  • As defined by clinical and radiological parameters, stage IB- IIB cervical cancer patients treated by cisplatin-based CCRT have greater toxicities but similar survival rate as those treated by RT alone

    2012

Secondary Outcomes (1)

  • To conduct a translational research to find out the molecular markers associated with radiosensitivity and distant metastasis in cervical cancer patients.

    2013

Study Arms (1)

ciaplantin,cancer,survival

EXPERIMENTAL
Drug: Cisplatin

Interventions

CisplatinDRUG

Cisplatin is available commercially as a sterile lyophilized white power in single-dose amber vials containing 10 mg or 50 mg of cisplatin for administration by IV infusion. Every effort should be made to obtain and record the lot numbers of the batches of cisplatin used. Unopened vials of cisplatin are stable for the shelf-life indicated on the package when stored in accordance with the manufacturers' instructions.

Also known as: Platinex (Cisplatin)
ciaplantin,cancer,survival

Eligibility Criteria

Age45 Years - 80 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pathologically confirmed squamous cell carcinoma of cervix
  • Clinical FIGO stage IB-IIB
  • Planned to be primarily treated by RT.
  • Age: 45 \< age\< 80
  • No enlarged pelvic or para-aortic LN shown in CT-MRI (by CT-MRI criteria) and positive LN in FDG-PET studies.
  • Patients must have adequate bone marrow, pulmonary, liver and renal function
  • The interval between RT and randomization is not greater than 6 weeks.
  • Performance status
  • Patients must have signed informed consent to participate this study

You may not qualify if:

  • Age ≧80 or \<=45
  • Documented pelvic LN or extrapelvic metastases: para-aortic LN, lung, liver
  • LN-positive on PET scans.
  • General medical condition or attitude makes them unsuitable for cisplatin therapy.
  • Small cell carcinoma, adenocarcinoma or adeno-adenosquamous carcinoma.
  • Previous pre-RT chemotherapy or pelvic RT

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Chang Gung Memory Hpspital

Kaohsiung City, Taiwan

Location

Chang Gung Memory Hpspital

Keelung, Taiwan

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Cisplatin1,2-diaminocyclohexaneplatinum II citrate

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)

Chlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum Compounds

Study Officials

  • Ji-Hong Hong, M.D

    Department of Radiation Oncology,LIN KOU

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 11, 2009

First Posted

February 18, 2009

Study Start

February 1, 2009

Primary Completion

January 1, 2012

Study Completion

January 1, 2013

Last Updated

January 5, 2010

Record last verified: 2009-02

Locations

TW(2)