Promising combo for cervical cancer hits roadblock: trial ends early
NCT ID NCT00421096
First seen Jun 25, 2026 · Last updated Sep 18, 2026 · Updated 3 times
Summary
This phase 2 trial tested a new treatment sequence for stage IB2 to IVA cervical cancer. Patients received a combination of gemcitabine and cisplatin chemotherapy along with radiation, followed by more gemcitabine. The goal was to see if this approach could improve progression-free survival. Only 19 people enrolled before the study was terminated, so the findings are limited.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Gemcitabine and cisplatin chemotherapy plus radiotherapy
- What this could lead to
- If successful, this could point toward a more effective treatment sequence for advanced cervical cancer.
- What could go wrong
- This was a small, early-phase trial that was terminated, so results are limited and may not be reliable. The combination also carries risks like low blood cell counts and organ toxicity.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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19 people
The number who actually took part.
- Started
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May 2005
- Finished
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Dec 2011
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 70 years
- Sex
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Female participants only
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Centre Leonard de Vinci
Dechy, 59187, France
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Centre Oscar Lambret
Lille, 59020, France
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Other studies related to the condition(s) this trial covers.
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