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

This study has been terminated.
(Problems of recruitment)
Information provided by (Responsible Party):
Centre Oscar Lambret Identifier:
First received: January 10, 2007
Last updated: July 23, 2012
Last verified: July 2012

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


Ages Eligible for Study:   18 Years to 70 Years
Genders 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)
  Contacts and Locations
Please refer to this study by its identifier: 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
  More Information

No publications provided

Responsible Party: Centre Oscar Lambret 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
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors processed this record on April 17, 2014