A randomised phase II study of radio-chemotherapy with or without panitumumab (Vectibix®) in irresectable squamous cell carcinoma or adenocarcinoma of the oesophagus (Panoramic) - PANORAMIC

niversity Medical Centre Nijmegen0 sites124 target enrollmentApril 8, 2010

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: histology proven irresectable squamous cell or adenocarcinoma of the oesophagus
Sponsor: niversity Medical Centre Nijmegen
Enrollment: 124
Status: Active, not recruiting
Last Updated: 4 years ago

No summary available.

Registry

who.int

Start Date

April 8, 2010

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

niversity Medical Centre Nijmegen

•Patients (18\-70 yrs) with histology proven untreated irresectable squamous cell carcinoma or adenocarcinoma of the oesophagus, with a Karnofsky performance status \=70% without distant metastases. Patients should have no contra\-indications for cytotoxic therapy or panitumumab or other serious (mental) illnesses or medical conditions. Patients may not have prior exposure to any EGFR pathway targeting agents, participate in another interventional study and should be able to give informed consent.
•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

•Patients with prior treatment for oesophageal cancer or with prior treatment with radiation therapy at the tumour or other site that will interfere with proposed treatment, who are pregnant or breast feeding, or planning to become pregnant within 6 months after the end of treatment or subjects (male or female) not willing to use highly effective methods of contraception (per institutional standard) during treatment and for 6 months after the end of treatment are excluded. Patients with a history of other prior malignancy in past 5 years, other than basal cell carcinoma, squamous cell carcinoma of the skin, or cervical carcinoma in situ are excluded as well.