Clinical trial · Interventional
Radiochemotherapy Followed by Adjuvant Chemotherapy Based on Gemcitabine in Uterine Cervical Cancer
Stage IB2 to IVA Uterine Cervical Cancer: Phase 2 Study to Assess a New Therapeutic Sequence Associating a Radiochemotherapy Followed by Adjuvant Chemotherapy Based on Gemcitabine
NCT00421096CI-TRIAL-00105531GEMCOLterminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 18, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260918-000001
Why stopped (as posted): Problems of recruitment
Summary
Brief summary (as posted)
The scope of the trial is to assess the efficacy of the association gemcitabine-cisplatin + radiotherapy followed by an adjuvant chemotherapy
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Uterine Cervical Cancer | Cervical Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cisplatin | Drug | Cisplatin | ALIAS |
| Gemcitabine | Drug | Gemcitabine | ALIAS |
| Radiotherapy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- patient with cervix cancer
- description
- will receive gemcitabine + cisplatin + radiotherapy
- interventionNames
- Drug: Gemcitabine
- Procedure: Radiotherapy
- Drug: Cisplatin
Primary outcomes (1)
- measure
- Progression-free survival
- timeFrame
- 3 years after the end of study treament
Secondary outcomes (2)
- measure
- Global survival
- timeFrame
- 5 years after the end of study treatment
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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: * 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)
References
Publications (0)
Data not yet available
No reference posted for this study.