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

This study has been terminated.
(Problems of recruitment)
Sponsor:
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
  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

Drug: Cisplatin
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Genital Diseases, Female
Genital Neoplasms, Female
Neoplasms
Neoplasms by Site
Urogenital Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Uterine Neoplasms
Cisplatin
Gemcitabine
Anti-Infective Agents
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antiviral Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014