Study of Respiratory Gated Proton Beam Radiotherapy for Inoperable Pancreas Carcinoma

Pancreatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00658801
• Other study ID #: NCCCTS-07-226
• Status: Terminated
• Phase: Phase 1
• First received: March 24, 2008
• Last updated: July 7, 2011
• Start date: January 2007
• Est. completion date: February 2010

Study information

• Verified date: July 2011
• Source: National Cancer Center, Korea
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: February 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Radiation:
• Respiratory gated proton beam radiotherapy
Prescription dose to PTV as according to the following dose escalation schema: Group 1: Tumor size =5cm Dose level 1: 60 GyE /20 fx, 3GyE fraction dose, 5 days/week. Dose level 2: 66 GyE /22 fx, 3GyE fraction dose, 5 days/week. Dose level 3: 72 GyE /24 fx, 3GyE fraction dose, 5 days/week. Group 2: 5cm <Tumor size =10cm Dose level 1: 54 GyE /18 fx, 3GyE fraction dose, 5 days/week. Dose level 2: 60 GyE /20 fx, 3GyE fraction dose, 5 days/week. Dose level 3: 66 GyE /22 fx, 3GyE fraction dose, 5 days/week.

Locations

Country	Name	City	State
Korea, Republic of	National Cancer Center Korea	Goyang	Gyeonggi

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Center, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	all cause mortality		two years	No