Know Cancer

forgot password

A Phase II Study of Respiratory Gated Proton Beam Radiotherapy for Inoperable Pancreas Carcinoma

Phase 1
18 Years
Not Enrolling
Pancreatic Cancer

Thank you

Trial Information

A Phase II Study of Respiratory Gated Proton Beam Radiotherapy for Inoperable Pancreas Carcinoma

Inclusion Criteria:

- Pathologically confirmed adenocarcinoma of the pancreas or a serum CA19-9 level
higher than normal limits and an pancreas cancer-compatible radiological features in
one or more in CT/MRI/PET scans

- Unresectable disease base on institutional standard criteria of unresectability or
recurrent disease following radical surgery. There is no evidence of metastatic
disease in the major viscera and no peritoneal seeding

- Patients with biliary or gastroduodenal obstruction must have drainage prior to
starting chemoradiation

- All malignant disease must be encompassable within a single irradiation field
(15x15cm maximum)

- All patients must have radiographically assessable disease

- No previous irradiation to the planned field

- Age of ≥ 18 years

- Performance status of 0 to 2 on the Eastern Cooperative Oncology Group (ECOG) score

- Required Entry Labortory Parameters:

- WBC count ≥ 2,000/mm3

- hemoglobin level ≥ 7.5 g/dL

- platelet count ≥ 100,000/mm3

- total bilirubin ≤ 2.0 mg/dL (Patients with elevated bilirubin due to obstruction
should be stented and their bilirubin should be decreased ≤ 2.0 mg/dL prior to
study entry)

- creatinine ≤ 3.0 mg/dL

- Oral intake (including J-tube feeding) of ≥ 1,500 calories/day should be maintained.

Exclusion Criteria:

- There is evidence of metastasis in the major viscera or peritoneal seeding.

- Age of < 18 years

- Previous history of RT adjacent to planned field

- Poor performance status of 3 to 4 on the Eastern Cooperative Oncology Group (ECOG)

- Pregnant or breast feeding status

- Previous history uncontrolled other malignancies within 2 years

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

all cause mortality

Outcome Time Frame:

two years

Safety Issue:



Korea: Food and Drug Administration

Study ID:




Start Date:

January 2007

Completion Date:

February 2010

Related Keywords:

  • Pancreatic Cancer
  • Carcinoma
  • Pancreatic Neoplasms