Uterine Cervical CancerPhase 2GEMCOLNCT00421096
Radiochemotherapy Followed by Adjuvant Chemotherapy Based on Gemcitabine in Uterine Cervical Cancer
A Phase 2 study testing Gemcitabine, Radiotherapy and Cisplatin in people with Uterine Cervical Cancer, run by Centre Oscar Lambret at 2 sites in France.
Trial summary
The scope of the trial is to assess the efficacy of the association gemcitabine-cisplatin + radiotherapy followed by an adjuvant chemotherapy Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Uterine Cervical Cancer
- What is being tested?
- Gemcitabine, Radiotherapy and Cisplatin
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 2 sitesFrance
- Study dates
- May 2005to Dec 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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)
Trial locations and contacts
2 sites in 1 country.
France2 sites
Centre Leonard de Vinci
Dechy, 59187
Centre Oscar Lambret
Lille, 59020
About this study
Official title: 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
The scope of the trial is to assess the efficacy of the association gemcitabine-cisplatin + radiotherapy followed by an adjuvant chemotherapy
- Conditions
- Uterine Cervical Cancer
- Being tested
- Gemcitabine, Radiotherapy, Cisplatin
- Keywords
- uterine cervical cancer
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GemcitabineDrug
125 mg/m² at day 1, 8, 15, 21 and 28, 2 hours before radiotherapy.
RadiotherapyProcedure or surgery
45Gy (5 x 1,8Gy/week) on pelvic area +/- boost (10 to 15Gy)
+/- 45Gy (5 x 1,8Gy/week)on lumbo-aortic area
CisplatinDrug
40 mg/m² at day 1, 8, 15, 21 and J28 before Gemcitabine and with a hyperhydration
| Study group | Role | What they receive |
|---|---|---|
| patient with cervix cancer | Experimental | will receive gemcitabine + cisplatin + radiotherapy Receives: Drug: Gemcitabine; Procedure: Radiotherapy; Drug: Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
Measured: 3 years after the end of study treament
Secondary outcomes (2)
Global survival
Measured: 5 years after the end of study treatment
safety
Measured: untill 5 years after study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2007 (estimated)
- Study startMay 2005
- Primary completionApr 2008
- Study completionDec 2011
Why it stopped: Problems of recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine Cervical CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Oscar Lambret
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- BELKACEMI Yazid, MD, Principal investigator, Centre Oscar Lambret
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00421096
- Sponsor's protocol ID
- GEMCOL-0401
- Other IDs
- 2005-003476-38, 2005
- Acronym
- GEMCOL
- Status last verified
- Sep 2026
- First submitted
- 10 Jan 2007
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00421096
- Acronym / sponsor ID
- GEMCOL / GEMCOL-0401
- Conditions
- Uterine Cervical Cancer
- Keywords
- uterine cervical cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Problems of recruitment
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Centre Oscar LambretUniversity, hospital or other
- Study start
- May 2005 (actual)
- Primary completion
- Apr 2008 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 11 Jan 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The scope of the trial is to assess the efficacy of the association gemcitabine-cisplatin + radiotherapy followed by an adjuvant chemotherapy
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patient with cervix cancer | Experimental | Drug: Gemcitabine, Procedure: Radiotherapy, Drug: Cisplatinwill receive gemcitabine + cisplatin + radiotherapy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gemcitabine125 mg/m² at day 1, 8, 15, 21 and 28, 2 hours before radiotherapy. | Drug | patient with cervix cancer |
| Radiotherapy45Gy (5 x 1,8Gy/week) on pelvic area +/- boost (10 to 15Gy) +/- 45Gy (5 x 1,8Gy/week)on lumbo-aortic area | Procedure or surgery | patient with cervix cancer |
| Cisplatin40 mg/m² at day 1, 8, 15, 21 and J28 before Gemcitabine and with a hyperhydration | Drug | patient with cervix cancer |
Primary outcome
Progression-free survival
Time frame: 3 years after the end of study treament
2 secondary outcomes
Global survival
Time frame: 5 years after the end of study treatment
safety
Time frame: untill 5 years after study treatment
Results and safety
The study was stopped early (reason given: Problems of recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
BELKACEMI Yazid, MD principal investigator
Centre Oscar Lambret
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Gemcitabine, Radiotherapy and Cisplatin in people with Uterine Cervical Cancer, run by Centre Oscar Lambret at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Problems of recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (time frame: 3 years after the end of study treament). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.