NCT01461772

Brief Summary

Concurrent chemoradiation therapy with weekly cisplatin is the current standard treatment for patients with locally advanced cervical cancer. However, weekly cisplatin is related to renal toxicity and not convenient regimen. Recently, carboplatin has proved to be a good radiosensitizer and less renal toxicity. Weekly carboplatin is more convenient regimen for both patients and physicians. Weekly carboplatin may have similar efficacy with weekly cisplatin and may have more favorable toxicity profile. Therefore, the investigators aimed to evaluate the efficacy and safety of concurrent chemoradiation with weekly carboplatin in patients with locally advanced cervical cancer.

Trial Health

57
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Trial Health Score

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

Enrollment
21

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Dec 2009

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
terminated

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

December 1, 2009

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

October 26, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 28, 2011

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

May 31, 2017

Status Verified

May 1, 2017

Enrollment Period

4.4 years

First QC Date

October 26, 2011

Last Update Submit

May 27, 2017

Conditions

Cervical Cancer

Outcome Measures

Primary Outcomes (1)

  • Response rate

    3 months after completion of study treatment

Secondary Outcomes (4)

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

    Before each chemotherapy, an average of 1 week

  • Disease-free survival

    2 years after completion of study treatment

  • Overall survival

    2 years after completion of study treatment

  • Quality of life

    3 months after completion of study treatment

Study Arms (2)

CCRT weekly carboplatin

EXPERIMENTAL

Concurrent chemoradiation therapy with weekly carboplatin

Radiation: Radiation therapyDrug: Carboplatin

CCRT weekly cisplatin

ACTIVE COMPARATOR

Concurrent chemoradiation therapy with weekly cisplatin

Radiation: Radiation therapyDrug: Cisplatin

Interventions

Radiation therapyRADIATION

pelvic radiation therapy (Extended filed radiation therapy and addition of brachytherapy is allowed)

CCRT weekly carboplatinCCRT weekly cisplatin
CarboplatinDRUG

carboplatin 130mg/m2BSA on day 1,8,15,22,29,and 36

CCRT weekly carboplatin
CisplatinDRUG

Cisplatin 40mg/m2BSA on day 1,8,15,22,29,and 36

CCRT weekly cisplatin

Eligibility Criteria

Age20 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Previously untreated, histologically confirmed cervical cancer
  • One of following histologic types Squamous carcinoma, adenocarcinoma, adenosquamous carcinoma
  • Age: 20-75 years
  • GOG performance status: 0-2
  • Adequate organ function Bone marrow: WBC ≥ 3,000/mm3, ANC ≥ 1,500/mm3, Platelet ≥ 100X103/mm3, Hb ≥ 10.0 g/dl Kidney: Creatinine \< 1.25 × UNL, Liver : AST, ALT \< 3 × UNL, T- bilirubin \< 1.5 mg/ mm3
  • Contraception during study treatment
  • Informed consent

You may not qualify if:

  • Previous chemotherapy or pelvic radiation therapy
  • Hormone therapy within 4 weeks
  • Concomitant malignancy within 5 years except cured basal cell carcinoma of skin
  • Uncontrolled medical disease
  • Pregnant or lactating woman
  • Etc.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center

Seoul, 138-736, South Korea

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

RadiotherapyCarboplatinCisplatin

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)

TherapeuticsCoordination ComplexesOrganic ChemicalsChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum Compounds

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
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 26, 2011

First Posted

October 28, 2011

Study Start

December 1, 2009

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

May 31, 2017

Record last verified: 2017-05

Locations

KR(1)