Pancreatic CancerPhase 1NCT00658801
Study of Respiratory Gated Proton Beam Radiotherapy for Inoperable Pancreas Carcinoma
A Phase 1 study testing Respiratory gated proton beam radiotherapy in people with Pancreatic Cancer, run by National Cancer Center, Korea at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- Respiratory gated proton beam radiotherapy
- Type of treatment
- Surgery or procedure
- How many people
- 4 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2007to Feb 2010
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
National Cancer Center Korea
Goyang-si, Gyeonggi-do, 410-769
About this study
Official title: 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.
- Conditions
- Pancreatic Cancer
- Being tested
- Respiratory gated proton beam radiotherapy
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Respiratory gated proton beam radiotherapyRadiation
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
all cause mortality
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2008 (estimated)
- Study startJan 2007
- Primary completionFeb 2010
- Study completionFeb 2010
Why it stopped: difficult to register
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Center, Korea
- Sponsor type
- Other government
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00658801
- Sponsor's protocol ID
- NCCCTS-07-226
- Status last verified
- Jul 2011
- First submitted
- 24 Mar 2008
- Last updated
- 8 Jul 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Respiratory Gated Proton Beam Radiotherapy for Inoperable Pancreas Carcinoma
- ClinicalTrials.gov ID
- NCT00658801
- Acronym / sponsor ID
- NCCCTS-07-226
- Conditions
- Pancreatic Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: difficult to register
- Enrolment
- 4 participants (actual)
- Lead sponsor
- National Cancer Center, KoreaOther government
- Study start
- Jan 2007
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 15 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Respiratory gated proton beam radiotherapyPrescription 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. | Radiation | – |
Primary outcome
all cause mortality
Time frame: two years
Results and safety
The study was stopped early (reason given: difficult to register). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Respiratory gated proton beam radiotherapy in people with Pancreatic Cancer, run by National Cancer Center, Korea at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: difficult to register). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
all cause mortality (time frame: two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2011.