A two-stage multicenter phase II trial of concurrent panitumumab immunotherapy, cisplatin chemotherapy and pelvic radiotherapy for primary cancer of the uterine cervix stage Ib-IIIb - AGO 20

• Conditions: primary cancer of the uterine cervix stage Ib-IIIb

• Registration Number: EUCTR2009-012453-38-AT
• Lead Sponsor: Studienzentrale AGO Austria

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07-20
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: Not specified

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

Not provided

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified