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

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00421096

Acronym

GEMCOL

Enrollment

Registered

2007-01-11

Start date

2005-05-01

Completion date

2011-12-01

Last updated

2026-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Uterine Cervical Cancer

Keywords

uterine cervical cancer

Brief summary

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

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 70 Years

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame
Progression-free survival	3 years after the end of study treament

Secondary

Measure	Time frame
Global survival	5 years after the end of study treatment
safety	untill 5 years after study treatment

Countries

France

Contacts

PRINCIPAL_INVESTIGATORBELKACEMI Yazid, MD

Centre Oscar Lambret

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 18, 2026