Pancreatic CancerPhase 2NCT00658840
Concurrent Chemo-radiotherapy With Capecitabine for Unresectable Locally Advanced Pancreatic Carcinoma
A Phase 2 study testing Capecitabine (Xeloda®) and Localization, simulation and immobilization 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?
- Capecitabine (Xeloda®) and Localization, simulation and immobilization
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2006to Jun 2013
- Phase
- Phase 2
- 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
- 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
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- performance status of 0 to 2 on the Eastern Cooperative Oncology Group (ECOG) score
- Required Entry Laboratory Parameters WBC count ≥ 2,000/mm3;(ANC>1,000), hemoglobin level ≥ 7.5 g/dL; platelet count ≥ 100,000/mm3; total bilirubin ≤ 3.0 mg/dL (Patients with elevated bilirubin due to obstruction should be stented and their bilirubin should be decreas ≤ 3.0 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 of uncontrolled other malignancies within 2 years
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
National Cancer Center Korea
Goyang-si, Gyeonggi-do, 410-769
Tae Hyun Kim, 82-31-920-0155, krog@ncc.re.kr
About this study
Official title: A Phase II Study of Concurrent Chemo-radiotherapy With Capecitabine for Unresectable Locally Advanced Pancreatic 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. The purpose of this trial is to improve the therapeutic effects by using proton therapy and chemotherapy concurrently.
- Conditions
- Pancreatic Cancer
- Being tested
- Capecitabine (Xeloda®), Localization, simulation and immobilization
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Capecitabine (Xeloda®)Drug
Capecitabine is administered orally at a dose of 800 mg/m2 twice daily (total daily dose 1600mg/ m2) continuous regimen regimen during RT (5 days of treatment followed by a 2 day rest: Saturday and Sunday). Capecitabine is given approximately 12 hours apart and taken orally with water within 30 minutes after ingestion of food (breakfast or dinner).
Localization, simulation and immobilizationRadiation
Radiation dose and planning
- Total dose 55.8Gy, 28 fractions, 6-7 weeks (1.8 Gy/day). A cone down after 45 Gy will be performed to emcompass GTV with a margin of 1-1.5cm.
- Dose prescription : 90% isodose volume of prescribed dose encompassed PTV
- The dose-volume histogram (DVH) of targets, such as GTV, CTV, and PTV, and the normal tissues, such as the liver, duodenum, stomach, the kidneys, spinal cord, etc., was calculated.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Primary objectives :
To evaluate the tumor response rate, local control rate and compliance (acute and late toxicity, esp. gastrointestinal tract toxicity) of concurrent chemo-radiotherapy with oral capecitabine in patients with unresectable locally advanced pancreatic carcinoma
Secondary objectives :
To evaluate the impact of concurrent chemo-radiotherapy with oral capecitabine in patients with unresectable locally advanced pancreatic carcinoma by analyzing the progression-free survival rate and overall survival rate. Receives: Drug: Capecitabine (Xeloda®); Radiation: Localization, simulation and immobilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
all cause mortality
Measured: two year
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 startJun 2006
- Primary completionJun 2013 (estimated)
- Study completionJun 2013 (estimated)
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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Center, Korea
- Sponsor type
- Other government
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00658840
- Sponsor's protocol ID
- NCCCTS-06-199
- Status last verified
- Apr 2012
- First submitted
- 24 Mar 2008
- Last updated
- 3 Apr 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Concurrent Chemo-radiotherapy With Capecitabine for Unresectable Locally Advanced Pancreatic Carcinoma
- ClinicalTrials.gov ID
- NCT00658840
- Acronym / sponsor ID
- NCCCTS-06-199
- Conditions
- Pancreatic Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- National Cancer Center, KoreaOther government
- Study start
- Jun 2006
- Primary completion
- Jun 2013 (estimated)
- Study completion
- Jun 2013 (estimated)
- 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. 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)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Capecitabine (Xeloda®), Radiation: Localization, simulation and immobilizationPrimary objectives : To evaluate the tumor response rate, local control rate and compliance (acute and late toxicity, esp. gastrointestinal tract toxicity) of concurrent chemo-radiotherapy with oral capecitabine in patients with unresectable locally advanced pancreatic carcinoma Secondary objectives : To evaluate the impact of concurrent chemo-radiotherapy with oral capecitabine in patients with unresectable locally advanced pancreatic carcinoma by analyzing the progression-free survival rate and overall survival rate. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
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 |
|---|---|---|
| Capecitabine (Xeloda®)Capecitabine is administered orally at a dose of 800 mg/m2 twice daily (total daily dose 1600mg/ m2) continuous regimen regimen during RT (5 days of treatment followed by a 2 day rest: Saturday and Sunday). Capecitabine is given approximately 12 hours apart and taken orally with water within 30 minutes after ingestion of food (breakfast or dinner). | Drug | 1 |
| Localization, simulation and immobilizationRadiation dose and planning 1. Total dose 55.8Gy, 28 fractions, 6-7 weeks (1.8 Gy/day). A cone down after 45 Gy will be performed to emcompass GTV with a margin of 1-1.5cm. 2. Dose prescription : 90% isodose volume of prescribed dose encompassed PTV 3. The dose-volume histogram (DVH) of targets, such as GTV, CTV, and PTV, and the normal tissues, such as the liver, duodenum, stomach, the kidneys, spinal cord, etc., was calculated. | Radiation | 1 |
Primary outcome
all cause mortality
Time frame: two year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2012.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Capecitabine (Xeloda®) and Localization, simulation and immobilization 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 9 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: status not confirmed, as of the sponsor's last update on 3 Apr 2012. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tae Hyun Kim (82-31-920-0155, krog@ncc.re.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
all cause mortality (time frame: two year). 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 3 Apr 2012.