Study of Respiratory Gated Proton Beam Radiotherapy for Inoperable Pancreas Carcinoma

National Cancer Center (NCC)

Status and phase

Terminated

Phase 1

Conditions

Pancreatic Cancer

Treatments

Radiation: Respiratory gated proton beam radiotherapy

Study type

Interventional

Funder types

Other

Identifiers

NCT00658801

NCCCTS-07-226

Details and patient eligibility

About

The only curative option for pancreatic cancer patients is surgery, but the patients within 20% of them are possible for a radical surgery. Accordingly, concurrent chemo-radiation therapy is generally used for palliation of unresectable pancreatic cancer patients. So far, the use of 5-fluorouracil (5-FU) was the traditional method of chemotherapy. However, these days, oral anti-cancer medicine, capecitabine(Xeloda®), was developed and considered as an alternative medicine of 5-fluorouracil (5-FU). Furthermore, according to the recent results of clinical trials, the clinical use of capecitabine(Xeloda®) with radiation therapy was proved to be very effective and safe. Proton therapy is a new radiation therapy which remaining energy is released when they reach the tumor, delivering the most effective dose of radiation and which can minimize the exposure to normal tissues. The purpose of this trial is to improve the therapeutic effects by using proton therapy and chemotherapy concurrently.

Enrollment

4 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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) score
Pregnant or breast feeding status
Previous history uncontrolled other malignancies within 2 years