Radiochemotherapy Followed by Adjuvant Chemotherapy Based on Gemcitabine in Uterine Cervical Cancer (GEMCOL)
This study has been terminated.
(Problems of recruitment)
Sponsor:
Centre Oscar Lambret
Information provided by (Responsible Party):
Centre Oscar Lambret
ClinicalTrials.gov Identifier:
NCT00421096
First received: January 10, 2007
Last updated: July 23, 2012
Last verified: July 2012
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Purpose
The scope of the trial is to assess the efficacy of the association gemcitabine-cisplatin + radiotherapy followed by an adjuvant chemotherapy
| Condition | Intervention | Phase |
|---|---|---|
|
Uterine Cervical Cancer |
Drug: Gemcitabine Procedure: Radiotherapy Drug: Cisplatin |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Centre Oscar Lambret:
Primary Outcome Measures:
- Progression-free survival [ Time Frame: 3 years after the end of study treament ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Global survival [ Time Frame: 5 years after the end of study treatment ] [ Designated as safety issue: No ]
- safety [ Time Frame: untill 5 years after study treatment ] [ Designated as safety issue: Yes ]
| Enrollment: | 19 |
| Study Start Date: | May 2005 |
| Study Completion Date: | December 2011 |
| Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: patient with cervix cancer
will receive gemcitabine + cisplatin + radiotherapy
|
Drug: Gemcitabine
125 mg/m² at day 1, 8, 15, 21 and 28, 2 hours before radiotherapy.
Procedure: Radiotherapy
45Gy (5 x 1,8Gy/week) on pelvic area +/- boost (10 to 15Gy) +/- 45Gy (5 x 1,8Gy/week)on lumbo-aortic area 40 mg/m² at day 1, 8, 15, 21 and J28 before Gemcitabine and with a hyperhydration
|
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00421096
Locations
| France | |
| Centre Leonard de Vinci | |
| Dechy, France, 59187 | |
| Centre Oscar Lambret | |
| Lille, France, 59020 | |
Sponsors and Collaborators
Centre Oscar Lambret
Investigators
| Principal Investigator: | BELKACEMI Yazid, MD | Centre Oscar Lambret |
More Information
No publications provided
| Responsible Party: | Centre Oscar Lambret |
| ClinicalTrials.gov Identifier: | NCT00421096 History of Changes |
| Other Study ID Numbers: | GEMCOL 0401 |
| Study First Received: | January 10, 2007 |
| Last Updated: | July 23, 2012 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by Centre Oscar Lambret:
|
uterine cervical cancer |
Additional relevant MeSH terms:
|
Uterine Cervical Neoplasms Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site Neoplasms Uterine Cervical Diseases Uterine Diseases Genital Diseases, Female Gemcitabine Cisplatin Antineoplastic Agents |
Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors |
ClinicalTrials.gov processed this record on May 16, 2013