Radiochemotherapy Followed by Adjuvant Chemotherapy Based on Gemcitabine in Uterine Cervical Cancer - Full Text View

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

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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Radiation Therapy

Drug Information available for: Gemcitabine Gemcitabine hydrochloride

U.S. FDA Resources

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
Estimated Study Completion Date:	December 2011
Primary Completion Date:	April 2008 (Final data collection date for primary outcome measure)

Intervention Details:

125 mg/m² at day 1, 8, 15, 21 and 28, 2 hours before 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 an hyperhydratation

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

Locations

France
Centre Oscar Lambret
Lille, France, 59020
Centre Leonard de Vinci
Dechy, France, 59187

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 - LILLE (France) ( LECLERCQ Bernard, Director )
Study ID Numbers:	2004-01
Study First Received:	January 10, 2007
Last Updated:	May 18, 2009
ClinicalTrials.gov Identifier:	NCT00421096 History of Changes
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:

Antimetabolites
Anti-Infective Agents
Immunologic Factors
Genital Neoplasms, Female
Adjuvants, Immunologic
Uterine Diseases
Urogenital Neoplasms
Antiviral Agents

Immunosuppressive Agents
Uterine Cervical Neoplasms
Genital Diseases, Female
Uterine Cervical Diseases
Radiation-Sensitizing Agents
Uterine Neoplasms
Gemcitabine

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Genital Neoplasms, Female
Uterine Diseases
Enzyme Inhibitors
Urogenital Neoplasms
Immunosuppressive Agents

Antiviral Agents
Pharmacologic Actions
Uterine Cervical Neoplasms
Genital Diseases, Female
Neoplasms
Uterine Cervical Diseases
Neoplasms by Site
Radiation-Sensitizing Agents
Therapeutic Uses
Uterine Neoplasms
Gemcitabine

ClinicalTrials.gov processed this record on September 09, 2009