Know Cancer

or
forgot password

Multicenter Prospective Randomized Phase II/III Study of Neoadjuvant Chemoradiation With Gemcitabine in Patients With Borderline Resectable Pancreatic Cancer


Phase 2/Phase 3
18 Years
75 Years
Open (Enrolling)
Both
Pancreatic Cancer

Thank you

Trial Information

Multicenter Prospective Randomized Phase II/III Study of Neoadjuvant Chemoradiation With Gemcitabine in Patients With Borderline Resectable Pancreatic Cancer


Inclusion Criteria:



- >18 years old or <75 years old

- ECOG 0-2

- biopsy proven adenocarcinoma of the pancreas

- no history of previous chemotherapy

- borderline resectable pancreas cancer

- no distant metastasis

- WBC at least 3,000/mm3 or absolute neutrophil count at least 1,500/mm3, Platelet
count at least 125,000/mm3

- Bilirubin less than 2.5 mg/dL AST less than 5 times upper limit of normal

- Creatinine no greater than 1.5 times upper limit of normal

- informed consent

Exclusion Criteria:

- history of previous chemotherapy

- history of radiation at >25% area of bone marrow

- stage unspecified, with distant metastasis, recurrent pancreas cancer

- history of malignant neoplasm (except stage 0 cancer, skin in situ cancer except
malignant melanoma). Patients who are NED after 5 years after treatment of malignant
neoplasm can be candidate of this study

- pregnant, breast-feeding patient

- uncontrolled or active infection

- uncontrolled cardiopulmonary disease

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

2-year survival rate

Outcome Time Frame:

2-year actual survival outcome

Safety Issue:

No

Principal Investigator

Jin-Young Jang, M.D., Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Seoul National University College of Medicine

Authority:

Korea: Institutional Review Board

Study ID:

BorderlinePancreas

NCT ID:

NCT01458717

Start Date:

November 2011

Completion Date:

December 2016

Related Keywords:

  • Pancreatic Cancer
  • pancreas
  • cancer
  • borderline resectable
  • locally advanced
  • resectability
  • chemotherapy
  • radiation
  • chemoradiation
  • neoadjuvant
  • survival
  • prognosis
  • recurrence
  • response rate
  • Pancreatic Neoplasms

Name

Location