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

Sponsor
Centre Oscar Lambret (Other)
Overall Status
Terminated
CT.gov ID
NCT00421096
Collaborator
(none)
19
Enrollment
2
Locations
1
Arm
79
Duration (Months)
9.5
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
19 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (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
Study Start Date :
May 1, 2005
Actual Primary Completion Date :
Apr 1, 2008
Actual Study Completion Date :
Dec 1, 2011

Arms and Interventions

Arm Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

  1. Progression-free survival [3 years after the end of study treament]

Secondary Outcome Measures

  1. Global survival [5 years after the end of study treatment]

  2. safety [untill 5 years after study treatment]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes 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

Locations

Site City State Country Postal Code
1 Centre Leonard de Vinci Dechy France 59187
2 Centre Oscar Lambret Lille France 59020

Sponsors and Collaborators

  • Centre Oscar Lambret

Investigators

  • Principal Investigator: BELKACEMI Yazid, MD, Centre Oscar Lambret

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Oscar Lambret
ClinicalTrials.gov Identifier:
NCT00421096
Other Study ID Numbers:
  • GEMCOL 0401
First Posted:
Jan 11, 2007
Last Update Posted:
Jul 24, 2012
Last Verified:
Jul 1, 2012
Keywords provided by Centre Oscar Lambret
uterine cervical cancer
Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Gemcitabine

Study Results

No Results Posted as of Jul 24, 2012