primary cancer of the uterine cervix stage Ib-IIIb
Conditions
Sponsors
Studienzentrale AGO Austria
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Primary diagnosis of either adenocarcinoma or squamous small-cell or large-cell, keratinizing or non-keratinizing carcinoma of the uterine cervix • Indication for primary chemoradiotherapy (both neoadjuvant and definitive treatment concepts are comprised) in patients with stage FIGO Ib-IIIb without paraaortic lymph node metastases, or with documented clinical indication for primary chemoradiotherapy • Absence of predominant and clinically effective neuroendocrine tumor cell differentiation • Absence of acute life-threatening vaginal hemorrhage (e.g. requiring emergency irradiation, RBC packs transfusion) • Absence of clinical indication for paraaortic field irradiation because of (preferably) histologically confirmed or unambiguous radiologic evidence of paraaortic lymph node metastasis • WHO performance status 0, 1 or 2 • No current or prior malignancy within previous 5 years (other than current ovarian cancer or adequately treated non melanoma skin cancer or in-situ carcinoma of the cervix) Version 1.0 / AGO20 June 18, 2009 Page 11 of 78 • Serum creatinine clearance >50 ml/min (measured or calculated) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the activity of concurrent Pmab-CRT in KRASwt patients (measured by 4-month rate of progression-free survival of target lesion [i.e. uterine tumor] MRI measures according to RECIST To assess the rate of photosensitivity, acneiform rash and dermatitis and/or gastrointestinal perforations of Pmab-CRT in KRASwt patients (measured by CTCAE grades at 4 months);Primary end point(s): Responserate and safety;Secondary Objective: • To assess the activity of study treatment in KRASwt positive and negative patients (measured by 4-month ORR according to RECIST) • To assess the activity of concurrent Pmab-CRT in KRASwt positive and negative patients (measured by 12-month and 24-month rate of progression-free survival of target lesion measures according to RECIST) • To assess the activity of concurrent Pmab-CRT in KRASwt positive and negative patients (measured by 12-month and 24-month rate of overall survival) • To assess the rate of (severe) adverse events during Pmab-CRT in KRASwt and KRASmt patients (measured by CTCAE grades 4 months after treatment initiation) • To assess the rate of post-treatment (severe) adverse events (measured by CTCAE grades 12 months and 24-months after treatment initiation) • To assess the rate of (severe) adverse events of Pmab monotherapy (measured by CTCAE grades after Pmab monotherapy [at d14]) | — |
Countries
Austria
Outcome results
None listed