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TerminatedNCT00421096GEMCOLUpdated Sep 17, 2026

Radiochemotherapy Followed by Adjuvant Chemotherapy Based on Gemcitabine in Uterine Cervical Cancer

A Phase 2 interventional study of Gemcitabine and Radiotherapy in Uterine Cervical Cancer, sponsored by Centre Oscar Lambret. Terminated at 2 sites in France. Open to female participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-09-17.

Sponsored by Centre Oscar Lambret · Phase 2, Interventional, and Treatment

Why this study was terminated
Problems of recruitment

From the registry’s dates

  • Registered 1 year 8 months after the study started (first participant enrolled May 2005, registered Jan 2007).
Phase
Phase 2
Study type
Interventional
Enrollment
19
Allocation
Non-randomized
Ages
18 Years to 70 Years
Sex
Female
01

Study summary

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

02

Conditions studied

  • Uterine Cervical Cancer

Keywords

  • uterine cervical cancer
03

In context

Uterine Cervical Neoplasms

1,881 studies on the registry are indexed under Uterine Cervical Neoplasms; 567 are open to participants now.

This study's enrollment of 19 is below the median of 100 across 1,377 interventional studies indexed under Uterine Cervical Neoplasms.

Browse Uterine Cervical Neoplasms studies →

Lead sponsor

Centre Oscar Lambret is the lead sponsor of 127 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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)
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
19 participants (actual)

Study arms

  • Experimental
    patient with cervix cancer

    will receive gemcitabine + cisplatin + radiotherapy

    Drug: Gemcitabine · Procedure: Radiotherapy · Drug: Cisplatin

Interventions

  • DrugGemcitabine

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

  • ProcedureRadiotherapy

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

  • DrugCisplatin

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

06

What researchers measure

Primary outcomes

  1. Progression-free survival

    Time frame: 3 years after the end of study treament

Secondary outcomes

  1. Global survival

    Time frame: 5 years after the end of study treatment

  2. safety

    Time frame: untill 5 years after study treatment

07

Study locations

2 sites
  • Centre Leonard de Vinci
    Dechy, 59187, France
  • Centre Oscar Lambret
    Lille, 59020, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00421096
Lead sponsor
Centre Oscar Lambret
Responsible party
Sponsor
First posted
Jan 11, 2007
Start date
May 2005
Primary completion
Apr 2008
Completion
Dec 2011
Last update
Sep 17, 2026

Study contacts

BELKACEMI Yazid, MD
principal investigator · Centre Oscar Lambret

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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