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OpenTrials
Terminated

NCT Number: NCT00421096

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

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

Why the study stopped: Problems of recruitment
Terminated

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Key information

Conditions

Uterine Cervical Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Centre Leonard de Vinci, Dechy, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Gemcitabine

Drug

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

Radiotherapy

Procedure

45Gy (5 x 1,8Gy/week) on pelvic area +/- boost (10 to 15Gy)

+/- 45Gy (5 x 1,8Gy/week)on lumbo-aortic area

Cisplatin

Drug

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

Primary outcomes

  1. Progression-free survival

    Time frame: 3 years after the end of study treament

Secondary outcomes

  1. Global survival

    Time frame: 5 years after the end of study treatment

  2. safety

    Time frame: untill 5 years after study treatment

Sponsors and collaborators

Lead sponsor

Centre Oscar Lambret

Other

Registry information

Official study 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

Acronym: GEMCOL

Important dates

Study start
2005
Primary completion
2008
Study completion
2011
First posted
Jan 11, 2007
Registry last updated
Sep 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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