NCT00421096

Brief Summary

The scope of the trial is to assess the efficacy of the association gemcitabine-cisplatin + radiotherapy followed by an adjuvant chemotherapy

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
19

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started May 2005

Longer than P75 for phase_2

Geographic Reach
1 country

2 active sites

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

May 1, 2005

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

January 10, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 11, 2007

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
3.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

September 17, 2026

Status Verified

September 1, 2026

Enrollment Period

2.9 years

First QC Date

January 10, 2007

Last Update Submit

September 15, 2026

Conditions

Uterine Cervical Cancer

Keywords

uterine cervical cancer

Outcome Measures

Primary Outcomes (1)

  • Progression-free survival

    3 years after the end of study treament

Secondary Outcomes (2)

  • Global survival

    5 years after the end of study treatment

  • safety

    untill 5 years after study treatment

Study Arms (1)

patient with cervix cancer

EXPERIMENTAL

will receive gemcitabine + cisplatin + radiotherapy

Drug: GemcitabineProcedure: RadiotherapyDrug: Cisplatin

Interventions

GemcitabineDRUG

125 mg/m² at day 1, 8, 15, 21 and 28, 2 hours before radiotherapy.

patient with cervix cancer
RadiotherapyPROCEDURE

45Gy (5 x 1,8Gy/week) on pelvic area +/- boost (10 to 15Gy) +/- 45Gy (5 x 1,8Gy/week)on lumbo-aortic area

patient with cervix cancer
CisplatinDRUG

40 mg/m² at day 1, 8, 15, 21 and J28 before Gemcitabine and with a hyperhydration

patient with cervix cancer

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 18 and 70 years old
  • Cervical uterine cancer (epidermoid or adenocarcinoma, stage:from IB\> or = 4 cm to IV, according to FIGO classification) histologically proven
  • Measurable lesions,clinically and by MRI assessed
  • PS-WHO \< or = 2 ou Karnofsky Index \>70 per cent
  • Life expectancy \> 3 months
  • Hematologic function: leukocytes \< or = 3 G/l, polynuclear neutrophil leukocytes \> or = 1.5 G/l, platelets \> or = 100 G/l, hemoglobin \> or = 10 g/dl
  • Hepatic function: ASAT and ALAT \< 2.5 ULN
  • Renal function: creatininemia \< 1.5 ULN, clearance \> 60 ml/min
  • No prior chemotherapy or radiotherapy
  • Contraception
  • Written informed consent signed

You may not qualify if:

  • Stage IB \< 4 cm or IVB
  • Other histology than epidermoid or adenocarcinoma
  • Distant metastases, including sus-clavicular adenopathy
  • Contraindication to MRI
  • Pregnant or lactating woman
  • Auto-immune disease
  • Peripheric neuropathy, autograft or homograft, psychiatric disease
  • Prior cancer (except cutaneous basocellular carcinoma and uterine cervical carcinoma in situ)
  • Active infection
  • Other clinical trial with an experimental drug
  • Known positive serology (HIV, HbC, HbS)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Centre Leonard de Vinci

Dechy, 59187, France

Location

Centre Oscar Lambret

Lille, 59020, France

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

GemcitabineRadiotherapyCisplatin

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)

Heterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingTherapeuticsChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum Compounds

Study Officials

  • BELKACEMI Yazid, MD

    Centre Oscar Lambret

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

January 10, 2007

First Posted

January 11, 2007

Study Start

May 1, 2005

Primary Completion

April 1, 2008

Study Completion

December 1, 2011

Last Updated

September 17, 2026

Record last verified: 2026-09

Locations

FR(2)