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
- 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.
- 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
- 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
- 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.
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Recurrence-free survival at 2 years
Susan Scholl, MD