Back to resultsRadiochemotherapy Followed by Adjuvant Chemotherapy Based on Gemcitabine in Uterine Cervical Cancer (GEMCOL)
Primary Purpose
Uterine Cervical Cancer
Status
Terminated
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Gemcitabine
Radiotherapy
Cisplatin
Sponsored by
About this trial
This is an interventional treatment trial for Uterine Cervical Cancer focused on measuring uterine cervical cancer
Eligibility Criteria
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)
Sites / Locations
- Centre Leonard de Vinci
- Centre Oscar Lambret
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
patient with cervix cancer
Arm Description
will receive gemcitabine + cisplatin + radiotherapy
Outcomes
Primary Outcome Measures
Progression-free survival
Secondary Outcome Measures
Global survival
safety
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00421096
Brief Title
Radiochemotherapy Followed by Adjuvant Chemotherapy Based on Gemcitabine in Uterine Cervical Cancer
Acronym
GEMCOL
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2012
Overall Recruitment Status
Terminated
Why Stopped
Problems of recruitment
Study Start Date
May 2005 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Oscar Lambret
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The scope of the trial is to assess the efficacy of the association gemcitabine-cisplatin + radiotherapy followed by an adjuvant chemotherapy
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uterine Cervical Cancer
Keywords
uterine cervical cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
patient with cervix cancer
Arm Type
Experimental
Arm Description
will receive gemcitabine + cisplatin + radiotherapy
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Intervention Description
125 mg/m² at day 1, 8, 15, 21 and 28, 2 hours before radiotherapy.
Intervention Type
Procedure
Intervention Name(s)
Radiotherapy
Intervention Description
45Gy (5 x 1,8Gy/week) on pelvic area +/- boost (10 to 15Gy)
+/- 45Gy (5 x 1,8Gy/week)on lumbo-aortic area
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
40 mg/m² at day 1, 8, 15, 21 and J28 before Gemcitabine and with a hyperhydration
Primary Outcome Measure Information:
Title
Progression-free survival
Time Frame
3 years after the end of study treament
Secondary Outcome Measure Information:
Title
Global survival
Time Frame
5 years after the end of study treatment
Title
safety
Time Frame
untill 5 years after study treatment
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
BELKACEMI Yazid, MD
Organizational Affiliation
Centre Oscar Lambret
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Leonard de Vinci
City
Dechy
ZIP/Postal Code
59187
Country
France
Facility Name
Centre Oscar Lambret
City
Lille
ZIP/Postal Code
59020
Country
France
12. IPD Sharing Statement
Learn more about this trial
Radiochemotherapy Followed by Adjuvant Chemotherapy Based on Gemcitabine in Uterine Cervical Cancer
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