None listed
Conditions
Interventions
All patients enrolled in the study will receive the same treatment consisting of all of the following:
a) 1 cycle of chemotherapy: the cycle is 28 days (gemcitabine on days 1 and 15 and oxaliplatin on days 2 and 16, followed by:
b)radiotherpay plus continuous 5FU infusion: 5FU is given continuously (7 days a week for 6 weeks), radiotherpay is given 5 days a week (Mon-Fri) for 6 weeks followed by:
c) 3 cycles of chemotherapy: each cycle is 28 days (gemcitabine on days 1 and 15 and oxaliplatin on
All patients enrolled in the study will receive the same treatment consisting of all of the following: a) 1 cycle of chemotherapy: the cycle is 28 days (gemcitabine on days 1 and 15 and oxaliplatin on days 2 and 16, followed by: b)radiotherpay plus continuous 5FU infusion: 5FU is given continuously (7 days a week for 6 weeks), radiotherpay is given 5 days a week (Mon-Fri) for 6 weeks followed by: c) 3 cycles of chemotherapy: each cycle is 28 days (gemcitabine on days 1 and 15 and oxaliplatin on days 2 and 16
Sponsors
AGITG
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
0 to No maximum
Healthy volunteers
No
Inclusion criteria
Patient must have histologically/cytologically proven adenocarcinoma of the pancreas located in the head or the body of the pancreas (primary) or in the pancreatic bed (locally recurrent).Locoregional disease must be confirmed by dual phase CT (arterial and portal phases) without distant metastases (confirmed by CT of the chest, abdomen and pelvis).Patients must be assessed by a surgeon and considered inoperable.Performance status must be ECOG grade 0, 1 or 2.
Exclusion criteria
1.Histological types other than pancreatic ductal adenocarcinoma 2. Metastatic disease. 3. Tumours of the tail of pancreas 4. Major co-morbid illnesses that, in the opinion of the investigator, would jeopardise the likely completion of the treatment program 5. Patients with peripheral sensory neuropathy with functional impairment. 6. Derangement of LFTs consistent with hepatic cellular dysfunction (ALT and/or AST >3 times upper limit of normal), or a bilirubin >3 times upper limit of normal. Patients with LFTs consistent with hepatic obstruction that is relieved (eg. by stenting, bypass) are eligible, provided the bilirubin has fallen to <3 times upper limit of normal. 7. Patients with significant loss of bodyweight, who, at the investigator’s discretion, is deemed not suitable for this study (eg.>15% weight loss since surgery or diagnosis) 8. Treatment with a drug within the last 30 days that has not received regulatory approval at the time of study entry. 9. Treatment with any previous cytotoxic chemotherapy for this malignancy. Previous hormonal manipulation (including HRT) is allowed. 10. Previous abdominal radiotherapy 11. A previous history of malignancy other than non-melanomatous skin cancers, in –situ carcinoma, or patients who are disease–free from non-pancreatic tumours treated definitively more than 5 years ago. 12. Pregnant or lactating women, or women of childbearing potential not using adequate contraception.
Outcome results
None listed