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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


Phase 2
18 Years
70 Years
Not Enrolling
Female
Uterine Cervical Cancer

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Trial Information

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


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)

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Progression-free survival

Outcome Time Frame:

3 years after the end of study treament

Safety Issue:

No

Principal Investigator

BELKACEMI Yazid, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Centre Oscar Lambret

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

GEMCOL 0401

NCT ID:

NCT00421096

Start Date:

May 2005

Completion Date:

December 2011

Related Keywords:

  • Uterine Cervical Cancer
  • uterine cervical cancer
  • Uterine Cervical Neoplasms

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