Study of Respiratory Gated Proton Beam Radiotherapy for Inoperable Pancreas Carcinoma

This study has been terminated.
(difficult to register)
Sponsor:
Information provided by:
National Cancer Center, Korea
ClinicalTrials.gov Identifier:
NCT00658801
First received: March 24, 2008
Last updated: July 7, 2011
Last verified: July 2011

March 24, 2008
July 7, 2011
January 2007
February 2010   (final data collection date for primary outcome measure)
all cause mortality [ Time Frame: two years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00658801 on ClinicalTrials.gov Archive Site
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Study of Respiratory Gated Proton Beam Radiotherapy for Inoperable Pancreas Carcinoma
A Phase II Study of Respiratory Gated Proton Beam Radiotherapy for Inoperable Pancreas Carcinoma

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.

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Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Pancreatic Cancer
Radiation: Respiratory gated proton beam radiotherapy

Prescription dose to PTV as according to the following dose escalation schema:

  1. 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.
  2. 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.
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
4
February 2010
February 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT00658801
NCCCTS-07-226
Not Provided
Tae Hyun Kim, National Cancer Center Korea
National Cancer Center, Korea
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National Cancer Center, Korea
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP