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

Uterine Cervical Cancer Clinical Trial

— GEMCOL  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00421096
• Other study ID #: GEMCOL 0401
• Status: Terminated
• Phase: Phase 2
• First received: January 10, 2007
• Last updated: July 23, 2012
• Start date: May 2005
• Est. completion date: December 2011

Study information

• Verified date: July 2012
• Source: Centre Oscar Lambret
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 19
• Est. completion date: December 2011
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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)

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Uterine Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

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

Locations

Country	Name	City	State
France	Centre Leonard de Vinci	Dechy
France	Centre Oscar Lambret	Lille

Sponsors (1)

Lead Sponsor	Collaborator
Centre Oscar Lambret

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival		3 years after the end of study treament	No
Secondary	Global survival		5 years after the end of study treatment	No
Secondary	safety		untill 5 years after study treatment	Yes