NL-OMON34246
Not yet recruiting
Phase 2
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
niversitair Medisch Centrum Sint Radboud0 sites124 target enrollmentTBD
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- niversitair Medisch Centrum Sint Radboud
- Enrollment
- 124
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\-Age 18 \- 70 years
- •\-Histologically proven SCC or adenocarcinoma of the oesophagus
- •\-No proven (distant) metastases (ultrasonography, CT or MRI)
- •\-No prior treatment for carcinoma of the oesophagus
- •\-Karnofsky performance status \>\=70% (appendix A)
- •\-Irresectable disease as assessed by the multidisciplinary tumour board
- •\-All patients (male and female) must use effective contraception methods according to CPMP/ICH/286/95 if of reproductive potential (e.g. implants, injectables, combined oral contraceptives, IUDs, sexual abstinence or vasectomised partner), for the whole duration of the study and until six months after they received the last treatment dose
- •\-No contraindications for cytotoxic therapy or panitumumab:
- •\-No known hypersensitivity/allergy to any of the compounds used
- •\-Haematology:
Exclusion Criteria
- •\-Prior treatment for this tumour
- •\-Prior treatment with radiation therapy in the area of the oesophagus or other site that will interfere with proposed treatment
- •\-Subject pregnant or breast feeding, or planning to become pregnant within 6 months after the end of treatment.
- •\-Subject (male or female) is not willing to use highly effective methods of contraception (per institutional standard) during treatment and for 6 months (male or female) after the end of treatment.
- •\-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;Exclusion criteria for the PET\-scan
- •\-Severe claustrophobia
- •\-Diabetes mellitus (type I and II)
- •\-Serum glucose level \>11 mmol/L
Outcomes
Primary Outcomes
Not specified
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