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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00421096
Recruitment Status : Terminated (Problems of recruitment)
First Posted : January 11, 2007
Last Update Posted : July 24, 2012
Information provided by (Responsible Party):
Centre Oscar Lambret

Brief Summary:
The scope of the trial is to assess the efficacy of the association gemcitabine-cisplatin + radiotherapy followed by an adjuvant chemotherapy

Condition or disease Intervention/treatment Phase
Uterine Cervical Cancer Drug: Gemcitabine Procedure: Radiotherapy Drug: Cisplatin Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : May 2005
Actual Primary Completion Date : April 2008
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer
U.S. FDA Resources

Arm Intervention/treatment
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

Drug: Cisplatin
40 mg/m² at day 1, 8, 15, 21 and J28 before Gemcitabine and with a hyperhydration

Primary Outcome Measures :
  1. Progression-free survival [ Time Frame: 3 years after the end of study treament ]

Secondary Outcome Measures :
  1. Global survival [ Time Frame: 5 years after the end of study treatment ]
  2. safety [ Time Frame: untill 5 years after study treatment ]

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00421096

Centre Leonard de Vinci
Dechy, France, 59187
Centre Oscar Lambret
Lille, France, 59020
Sponsors and Collaborators
Centre Oscar Lambret
Principal Investigator: BELKACEMI Yazid, MD Centre Oscar Lambret

Responsible Party: Centre Oscar Lambret Identifier: NCT00421096     History of Changes
Other Study ID Numbers: GEMCOL 0401
First Posted: January 11, 2007    Key Record Dates
Last Update Posted: July 24, 2012
Last Verified: July 2012

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