TerminatedPhase 2

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

Stopped: Problems of recruitment

France19 participantsStarted 2005-05

Plain-language summary

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

Who can participate

Age range

18 Years – 70 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Progression-free survival

Timeframe: 3 years after the end of study treament

Trial details

NCT IDNCT00421096

SponsorCentre Oscar Lambret

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2008-04

View on ClinicalTrials.gov More Uterine Cervical Cancer trials