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A Multicentre Randomised Phase II Clinical Study of UFT/Leucovorin, Radiotherapy With or Without Cetuximab Following Induction Gemcitabine Plus Capecitabine in Patients With Locally Advanced Pancreatic Cancer (PERU)


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Pancreatic Cancer

Thank you

Trial Information

A Multicentre Randomised Phase II Clinical Study of UFT/Leucovorin, Radiotherapy With or Without Cetuximab Following Induction Gemcitabine Plus Capecitabine in Patients With Locally Advanced Pancreatic Cancer (PERU)


Locally advanced pancreatic cancer carries a poor prognosis with no survival advantage of
CRT over chemotherapy alone. 4 Phase II- III studies patients without disease progression
after 3 months of systemic chemotherapy and CRT had a longer survival than those continuing
on chemotherapy. Therefore chemotherapy followed by CRT may be a better approach. Also the
effect of blocking EGFR will be evaluated in locally advanced pancreatic cancer.
Gemcitabine and capecitabine combination will be used as neo-adjuvant chemotherapy.


Inclusion Criteria:



- Age >18

- Histological or cytological diagnosis of adeno- or undifferentiated non-small cell
carcinoma of pancreas.

- Considered to be unresectable based on following: extensive peri-pancreatic lymph
node involvement, encasement or occlusion of the SMV or SMV/portal vein confluence,
direct involvement of SMA, coeliac axis, inferior vena cava or aorta.

- Performance status 0-2

- No evidence of metastatic disease as determined by CT scan/ other investigations

- Adequate bone marrow function with platelets>100^9/l; WBC>3x10^9/l;neutrophils>
1.5x10^9/l

- Serum bilirubin ,1.5 x ULN and transaminases < 2.5 x ULN

- Calculated/measured GFR >50ml/min

- No concurrent uncontrolled medical condition

- No active malignant disease other than non-melanotic skin cancer or carcinoma in situ
of the uterine cervix over the last 10 years

- Life expectancy > 3months

- Adequate contraceptive precautions

- Informed written consent

Exclusion Criteria:

- medical or psychiatric conditions that compromise the patient's ability to give
informed consent

- Presence of met. disease

- Concurrent uncontrolled medical conditions

- Any previous chemo/RT or any investigational treatment for advanced pancreatic
cancer.

- Adjuvant chemo + fluoropyrimidine or gemcitabine within 12months of trial entry

- Adjuvant RT with/without chemo for pancreatic cancer.

- Pregnancy/breast feeding

- Patients with known malabsorption syndromes ro a lack of physical treatment of the
upper GI tract.

- Patients with a known hypersensitivity to 5-FU or with a DPD deficiency.

- Clinically significant CVD

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

One year overall survival, measured from the date of registration.

Outcome Time Frame:

one year

Safety Issue:

No

Principal Investigator

Ian Chau

Investigator Role:

Principal Investigator

Investigator Affiliation:

The Royal Marsden NHS Trust

Authority:

United Kingdom: Research Ethics Committee

Study ID:

3065

NCT ID:

NCT01050426

Start Date:

March 2009

Completion Date:

September 2015

Related Keywords:

  • Pancreatic Cancer
  • Pancreatic Neoplasms

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