Phase II Randomized Assessing Pelvic Irradiation Combined With Cisplatin Alone or Cisplatin Plus Cetuximab in Patients With Carcinoma of the Cervix Stage IB2, II and III
18 Years
N/A
Female
Cervical Cancer
Trial Information
Phase II Randomized Assessing Pelvic Irradiation Combined With Cisplatin Alone or Cisplatin Plus Cetuximab in Patients With Carcinoma of the Cervix Stage IB2, II and III
OBJECTIVES:
Primary
- Evaluate the efficacy of treatment with cetuximab and a standard radiochemotherapy
regimen (pelvic radiotherapy and cisplatin) in patients with stage IB2, II, and IIIB
cervical cancer by evaluating the number of patients without recurrence at 2 years.
Secondary
- Analyze the tumor response by MRI after external radiotherapy.
- Assess the tolerance of cetuximab and standard radiochemotherapy in patients not
previously treated and in generally good condition.
- Study the correlation between treatment response and analysis of EGFR mutations (exons
18-21 of the tyrosine kinase domain including the two hot spots L858R and E746-A750).
- Study the correlation between treatment response and evaluation of number of copies of
the EGFR gene.
- Study the correlation between treatment response and analysis of mutations of codons 12
and 13 of KRAS2 by direct sequencing.
- Study the correlation between treatment response and research of DNA sequences of human
papillomavirus.
- Study the correlation between treatment response and overexpression of EGFR and COX2
(centralized) by IHC.
- Study the correlation between treatment response and characterization of a genomic
signature (genome, transcriptome, and Affymetrix chips from samples frozen in liquid
nitrogen).
- Collect tumor samples for molecular analysis.
OUTLINE: This is a multicenter study. Patients are stratified according to planned surgery
(yes vs no) and are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive cisplatin IV over 1 hour once weekly during weeks 1-6. Patients
also undergo pelvic radiotherapy 5 days a week during weeks 2-5 or 2-6.
- Arm II: Patients receive cisplatin and undergo radiotherapy as in arm I. Patients also
receive cetuximab IV over 1 hour once weekly during weeks 1-6.
After 6-8 weeks of study treatment, patients continue treatment as recommended by their
center (i.e., utero-vaginal brachytherapy, additional radiotherapy, or surgery).
Tumor tissue and blood samples are collected for further analysis.
After completion of study treatment, patients are followed at 3-4 weeks and then every 4
months for 2 years.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Diagnosis of cervical cancer
- Squamous cell carcinoma or adenocarcinoma
- Stage IB2-IIIB disease
- Not immediately operable
- Origin of the tumor and presence of measurable target lesion according to RECIST
criteria confirmed by T2-weighted MRI
- Data imaging scan and PET scan (optional) confirmed absence of lumbo-aortic
adenopathy
- No other associated pathology that would preclude study treatment
PATIENT CHARACTERISTICS:
- WHO performance status 0-1
- Hemoglobin > 10 g/dL
- ANC > 1,500/mm^3
- Platelet count > 100,000/mm^3
- Alkaline phosphatase < 2 times normal
- Total bilirubin < 1.5 times normal
- Creatinine < 130 μmol/L
- Creatinine clearance ≥ 60 mL/min
- Normal vital functions
- Not pregnant
- Fertile patients must use effective contraception
- Able to provide the imaging exams on CD ROM (DICOM 3.0 or higher) for centralized
review
- No history of another cancer that recurred within the past 5 years except for basal
cell carcinoma of the skin or carcinoma in situ of the cervix
- No absolute contraindication to MRI (i.e., claustrophobia, pacemaker, or cochlear
implant)
- No geographical, social, or psychological situations that preclude study follow up
- Not deprived of liberty or under guardianship
- Receiving benefits from a social security system
PRIOR CONCURRENT THERAPY:
- No prior treatment (i.e., chemotherapy, radiotherapy, immunotherapy, hormonal
therapy, or, especially, therapy with an investigational agent) for this cancer
- No concurrent participation in a clinical trial with an experimental agent
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Recurrence-free survival at 2 years
Safety Issue:
No
Principal Investigator
Susan Scholl, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Institut Curie
Authority:
Unspecified
Study ID:
CDR0000651250
NCT ID:
NCT00957411
Start Date:
March 2009
Completion Date:
Related Keywords:
- Cervical Cancer
- stage IB cervical cancer
- stage IIA cervical cancer
- stage IIB cervical cancer
- stage III cervical cancer
- cervical adenocarcinoma
- cervical squamous cell carcinoma
- Uterine Cervical Neoplasms
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