A multicentre randomised phase II clinical study of UFT/leucovorin (LV), radiotherapy with or without cetuximab following induction gemcitabine plus capecitabine in patients with locally advanced pancreatic cancer - PER

Phase 1

• Conditions: ocally-advanced (unresectable) pancreatic adenocarcinoma, undifferentiated carcinoma or non-small cell carcinoma.; MedDRA version: 9.1 Level: LLT Classification code 10033606 Term: Pancreatic cancer non-resectable

• Registration Number: EUCTR2008-000517-30-GB
• Lead Sponsor: The Royal Marsden Hospital NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-11-25
• Study Completion: 2015-07-20
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 17

Inclusion Criteria

a) Age >18 years.
b) Histological or cytological diagnosis of adeno- or undifferentiated non-small cell carcinoma of pancreas.
c) Considered to be unresectable
d)In patient with a histological diagnosis, paraffin embedded blocks and slides of tumour tissue should be available for centralised EGFR staining and K-ras testing.
e) WHO performance status 0-2.
f) No evidence of metastatic disease as determined by CT scan (chest, abdomen and pelvis) or other investigations such as PET scan or biopsy if required.
g) Adequate bone marrow function with platelets =100 x 109/l; WBC =3 x 109/l; neutrophils =1.5 x 109/l.
h) Serum bilirubin =1.5 × upper limit of institutional normal range (ULN) and transaminases =2.5? ULN.
i) Calculated/measured glomerular filtration rate =50ml/min
f) No concurrent uncontrolled medical condition.
j) No active malignant disease other than non-melanotic skin cancer or carcinoma in situ of the uterine cervix in the last 10 years.
k) Life expectancy > 3 months.
l) Adequate contraceptive precautions if relevant.
m) Informed written 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

Exclusion Criteria

a) Medical or psychiatric conditions that compromise the patient’s ability to give informed consent.
b) Presence of metastatic disease.
c) Concurrent uncontrolled medical conditions.
d) Any previous chemotherapy or radiotherapy, and any investigational treatment for advanced pancreatic cancer.
e) Adjuvant chemotherapy with fluoropyrimidine or gemcitabine within 12 months of trial entry.
f) Adjuvant radiotherapy with or without chemotherapy for pancreatic cancer
g) Pregnancy or breast feeding.
h) Patients with known malabsorption syndromes or a lack of physical integrity of the upper gastrointestinal tract.
i) Patients with a known hypersensitivity to 5-FU or with a dihydropyrimidine dehydrogenase (DPD) deficiency
j) Clinically significant (i.e. active) cardiovascular disease.

Study & Design

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