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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00421096
• Date of registration: 10/01/2007
• Prospective Registration: No
• Primary sponsor: Centre Oscar Lambret
• Public title: Radiochemotherapy Followed by Adjuvant Chemotherapy Based on Gemcitabine in Uterine Cervical Cancer GEMCOL
• Scientific 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
• Date of first enrolment: May 2005
• Target sample size: 19
• Recruitment status: Terminated
• URL: http://clinicaltrials.gov/show/NCT00421096
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

France

Contacts

• Name: BELKACEMI Yazid, MD
• Affiliation: Centre Oscar Lambret

Key inclusion & exclusion 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)



Age minimum: 18 Years
Age maximum: 70 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Uterine Cervical Cancer

Intervention(s)

Drug: Cisplatin

Drug: Gemcitabine

Procedure: Radiotherapy

Primary Outcome(s)

Progression-free survival [Time Frame: 3 years after the end of study treament]

Secondary Outcome(s)

Global survival [Time Frame: 5 years after the end of study treatment]

safety [Time Frame: untill 5 years after study treatment]

Secondary ID(s)

GEMCOL 0401

Source(s) of Monetary Support

Please refer to primary and secondary sponsors