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

This study is currently recruiting participants.

Verified by Centre Oscar Lambret, January 2007

Sponsored by:	Centre Oscar Lambret
Information provided by:	Centre Oscar Lambret
ClinicalTrials.gov Identifier:	NCT00421096

Purpose

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

Condition	Intervention	Phase
Uterine Cervical Cancer	Drug: Gemcitabine Procedure: Radiotherapy Drug: Cisplatine	Phase II

MedlinePlus related topics: Cancer

Drug Information available for: Gemcitabine hydrochloride Gemcitabine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy 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

Further study details as provided by Centre Oscar Lambret:

Primary Outcome Measures:

Progression-free survival

Secondary Outcome Measures:

Global survival

Estimated Enrollment:	73
Study Start Date:	May 2005
Estimated Study Completion Date:	May 2013

Detailed Description:

Further study details as provided by Centre Oscar Lambret

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 assesssed
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

Contacts

Contact: BELKACEMI Yazid, MD	+33 3 20 29 59 35	y-belkacemi@o-lambret.fr
Contact: VENDEL Yvette, CRA	+33 3 20 29 59 35	y-vendel@o-lambret.fr

Locations

France
Centre Oscar Lambret	Recruiting
Lille, France, 59020
Contact: BELKACEMI Yazid, MD +33 3 20 29 59 35 y-belkacemi@o-lambret.fr
Principal Investigator: CASTELAIN Bernard, MD
Sub-Investigator: BELKACEMI Yazid, MD
Sub-Investigator: LEBLANC Eric, MD
Sub-Investigator: NARDUCCI Fabrice, MD
Sub-Investigator: CHEVALIER-PLACE Annick, MD
Sub-Investigator: LEGRAND Edith, MD
Sub-Investigator: LESOIN Anne, MD
Centre Leonard de Vinci	Recruiting
Dechy, France, 59187
Contact: DARLOY Franck, MD +33 3 27 08 60 62 Fdarloy@clinique-psv-douai.fr
Principal Investigator: DARLOY Franck, MD

Sponsors and Collaborators

Centre Oscar Lambret

Investigators

Principal Investigator:

BELKACEMI Yazid, MD

Centre Oscar Lambret

More Information

Study ID Numbers:	2004-01
Study First Received:	January 10, 2007
Last Updated:	January 10, 2007
ClinicalTrials.gov Identifier:	NCT00421096
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by Centre Oscar Lambret:

uterine cervical cancer

Study placed in the following topic categories:

Genital Diseases, Female
Uterine Cervical Neoplasms
Uterine Cervical Diseases
Genital Neoplasms, Female

Uterine Diseases
Uterine Neoplasms
Urogenital Neoplasms
Gemcitabine

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Enzyme Inhibitors

Antiviral Agents
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on January 14, 2009