Pancreatic CancerPhase 2NCT00149578
A Phase II Study of Combine Modality Therapy in Locally Advanced Pancreatic Cancer
A Phase 2 study testing Gemcitabine Oxaliplatin 5FU and Leucovorin in people with Pancreatic Cancer, run by National Health Research Institutes, Taiwan at 2 sites in Taiwan.
Trial summary
Induction chemotherapy will be administered every 2 weeks for 6 cycles (about 3 months). Patients who have radiological evidence of progressive disease will be shifted to salvage chemotherapy. Read more about this study
- Who is it for?
- Ages 20 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- Gemcitabine Oxaliplatin 5FU and Leucovorin
- How many people
- 45 participants
- Where
- 2 sitesTaiwan
- Study dates
- Oct 2004to Oct 2008
- 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 20 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients must have histologically or cytologically confirmed adenocarcinoma of pancreas.
- Patients must have locally advanced pancreatic cancer.
- Patients must have unresectable pancreatic cancer evaluated by radiologist and/or surgeon according to either abdominal CT or MRI, or intra-operative findings.
- Locally advanced unresectable disease was defined by CT or MRI images as low-density tumor (primary and/or lymphadenopathy) with
- extension to the celiac axis or superior mesenteric artery,
- occlusion of the superior mesenteric-portal venous confluence
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- aortic, inferior vena cava (IVC) invasion or encasement
- invasion of SMV below transverse mesocolon
- rib, vertebral invasion
- Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >20 mm with conventional techniques or as >10 mm with spiral CT scan. See section 8.2 for the evaluation of measurable disease.
- Age >20 years. Because no dosing or adverse event data are currently available on the use of study agents in patients <20 years of age, children are excluded from this study.
- ECOG performance status 0-2; see Appendix A.
- Patients must have normal organ and marrow function as defined below:
- absolute neutrophil count >1,500/mL
- platelets >100,000/mL
- total bilirubin <3X institutional upper limit of normal
- ALT(SGPT) <5 X institutional upper limit of normal
- creatinine within normal institutional limits or creatinine clearance >60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal
- Patients who present with jaundice, temporary or permanent internal / external drainage before enrollment will be allowed.
- The effects of study agents on the developing human fetus at the recommended therapeutic dose are unknown. Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- Ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- Patients with distant metastases are not eligible.
- Patients may not be receiving any other investigational agents.
- Patients who have had prior chemotherapy or radiotherapy are not eligible.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agents used in the study.
- Patients who have above grade II peripheral neuropathy.
- Patients who had non-curable second primary malignancy.
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- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Pregnant women are excluded from this study because the study agents has the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with study agents, breastfeeding should be discontinued if the mother is treated with the study agents.
- Because patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy, HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with study agent administered during the study. Appropriate studies will be undertaken in patients receiving combination anti-retroviral therapy when indicated.
Trial locations and contacts
2 sites in 1 country.
Taiwan2 sites, 2 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 333
Hsiu-Po Wang, M.D., 886-2-23123456, whp@ha.mc.ntu.edu.tw
Jen-Shi Chen, M.D.
- Recruiting
Chang Gung Memorial Hospital
Taoyuan
Jen-Shi Chen, M.D., 886-3-3286778, fong0301@ms18.hinet.net
Hue-Chang Tsai, M.D.
About this study
Official title: A Phase II Study of Induction Chemotherapy Followed by Concurrent Chemotherapy With Radiotherapy in Locally Advanced Pancreatic Cancer
Induction chemotherapy will be administered every 2 weeks for 6 cycles (about 3 months). Patients who have radiological evidence of progressive disease will be shifted to salvage chemotherapy. Patients who have responsive or stable disease after induction chemotherapy will receive concurrent chemoradiotherapy 3-4 weeks after the last dose of induction chemotherapy. Surgical evaluation will be performed 4-6 weeks after the completion of chemoradiotherapy. Patients who have resectable disease will undergo surgical resection. Postoperative adjuvant chemotherapy with GOFL for 6 cycles will be given for those who have curative resection. Patients who still have unresectable disease or non-curative resection will receive systemic chemotherapy of GOFL till disease progression or unacceptable toxicity.
Read the detailed description
Induction chemotherapy will be administered on a biweekly basis. Reported adverse events and potential risks for gemcitabine, oxaliplatin, 5-FU and leucovorin are described in Section 6. Appropriate dose modifications for are described in Section 5. No investigational or commercial agents or therapies other than those described below may be administered with the intent to treat the patient's malignancy.
4.1.1 Treatment schedule of induction chemotherapy
For each dose of GOFL chemotherapy, intravenous infusion of gemcitabine at a fixed rate of 10 mg/m2/min will be immediately followed by a 2-hour intravenous infusion of oxaliplatin and then a 48-hour intravenous infusion of 5-FU and leucovorin.
4.1.2 Premedication before chemotherapy
Patients will receive 4mg of dexamethasone and anti-histamine and appropriate anti-emetics (serotonin antagonists) before each dose of chemotherapy.
4.2 Supportive Care Guidelines
Prophylactic G-CSF or GM-CSF will not be routinely used in this study. In case of febrile neutropenia, patients should be treated with appropriate antibiotics. Therapeutic G-CSF may be used at the discretion of attending physicians
4.3 Duration of Induction Chemotherapy
In the absence of treatment delays due to adverse events, treatment may continue for 6 cycles or until one of the following criteria applies:
C Disease progression, C Intercurrent illness that prevents further administration of treatment, C Unacceptable adverse events(s), C Patient decides to withdraw from the study, or C General or specific changes in the patient's condition render the patient unacceptable for further treatment in the judgment of the investigator.
4.4 Agents and Radiation Administration during Concurrent Chemoradiotherapy
4.4.1 Treatment schedule during concurrent chemoradiotherapy
4.4.1.1 Patient selection
Patients were evaluated after 6 cycles of induction chemotherapy. Patients who have progressive disease either due to distant metastasis or locoregional progression will be given salvage systemic chemotherapy and will not be enrolled into concurrent chemoradiotherapy. Patients who achieve complete remission, partial remission or stable disease will be enrolled into 2nd phase of the study, concurrent chemoradiotherapy, 3-4 weeks after the last dose of induction chemotherapy.
4.4.2 Study Agents
Gemcitabine 400mg/m2 will be dissolved in 250ml normal saline and infused intravenously at a fixed rate of 10mg/m2/min for 40 mins.
4.4.1.2 Treatment schedule
Gemcitabine 400mg/m2 in 250ml normal saline will be iv infused for 40mins, 2hrs before RT on day 1, 8, 15, 22, 29, 36. Radiation will be given 180cGy per day, 5 days a week for 28 fractions to totally 5040cGy.
4.4.1.3 Premedication for concurrent chemoradiotherapy
Patients were given dexamethasone 2mg orally three times a day (tid) from the morning of their first radiotherapy fraction. The prophylactic dexamethasone will be continued until after they had received their fifth radiation treatment. Therefore, depending on the day of the week the patients started treatment, dexamethasone will be taken for 5 to 7 days. All patients will be issued with rescue medication, prochlorperazine 10mg every 6 hours orally if they develop nausea and vomiting. If patients still have nausea and/or vomiting during treatment of dexamethasone and prochlorperazine or after the fifth day of radiotherapy, ondansetron 8mg orally or iv one to three times per day or granisetron 1mg per os or iv once everyday 30mins before radiotherapy should be given.
4.4.3 Radiation
4.4.3.1 Radiation technique
Radiation should be performed by high-energy linear accelerators. Three-dimensional radiation treatment planning was used in all cases. Patients will be immobilized in a foam cradle in a supine position, and the treatment planning CT was obtained. Tumor mapping should be performed according to treatment planning CT and the diagnostic CT before induction chemotherapy. Treatment planning was performed with the isocenter calculated at 100% and the 95% line encompassing the planning target volume. The spinal cord was limited to 4600cGy. If one kidney was to receive more than 20Gy then more than 90% of the remaining kidney was excluded from the primary beam. Generally, a three-field no-axial beam arrangement (opposed lateral with an anterior-inferior oblique) was used.
4.4.3.2 Radiation volume
The gross tumor volume is the primary tumor identifiable on CT scan before induction chemotherapy. The clinical target volume was defined as the gross tumor volume plus 0.5cm. The planning target volume was the clinical target volume plus 0.5cm for daily patient set-up variation. No prophylactic nodal irradiation will be given.
4.4.3.3 Radiation dosage
A total dose of 5040cGy in 28 fractions, 180cGy per fraction, one fraction per day, 5 days per week, will be given.
4.5 Surgery
4.5.1 Surgical evaluation
Patients completed induction chemotherapy and concurrent chemoradiotherapy will be evaluated for surgical resection. If there is evidence of distant metastasis, surgery will not be arranged. The feasibility of surgical resection will be evaluated by qualified surgeon according to contrast-enhanced abdominal CT or MRI. Laparoscope is optional for pre-surgical evaluation.
4.5.1.1 Resectable l No distant metastases l Clear fat plane around celiac and superior mesenteric arteries (SMA) l Patent superior mesenteric vein (SMV)/portal vein 4.5.1.2 Borderline resectable l Severe unilateral SMV/portal impingement l Tumor abutment on SMA l Gastroduodenal artery (GDA) encasement up to origin at hepatic artery l Colon or mesocolon invasion l Adrenal, colon or mesocolon, or kidney invasion 4.5.1.3 Unresectable l Distant metastases l SMA, celiac encasement l SMV/portal occlusion l Aortic, inferior vena cava (IVC) invasion or encasement l Invasion of SMV below transverse mesocolon l Rib, vertebral invasion
4.5.2 Treatment schedule of surgery
Surgery will be performed within 4-6 weeks after chemoradiotherapy complete.
4.5.3 Surgical technique
Patients whose tumor are considered to be resectable will undergo laparotomy. If complete surgical resection is feasible, optimal surgery will be performed. If complete surgical resection is impossible, biopsy with or without palliative surgery (eg. bypass surgery) may be performed. 4.6 Adjuvant/Maintenance Chemotherapy
4.6.1 Treatment schedule
Patients who have curative surgical resection will receive 6 cycles of adjuvant GOFL chemotherapy within 4 weeks after surgery and then followed up until tumor progression. Patients who are not feasible for curative resection, will receive continued chemotherapy of GOFL 3-4 weeks after chemoradiotherapy complete. The regimen will continue till disease progression. Patients who develop progressive disease during GOFL will shift to salvage chemotherapy.
- Conditions
- Pancreatic Cancer
- Being tested
- Gemcitabine Oxaliplatin 5FU and Leucovorin
- Keywords
- pancreatic cancer, gemcitabine, oxaliplatin, 5-Fluorouracil, radiation
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gemcitabine Oxaliplatin 5FU and LeucovorinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary end point is to evaluate the local response rate after induction chemotherapy and concurrent chemoradiotherapy in locally advanced pancreatic cancer.
chemotherapy and concurrent chemoradiotherapy in locally advanced pancreatic cancer. .
Secondary outcomes (1)
The secondary end points are to evaluate the distant metastasis rate and time to tumor progression, overall survival time and quality of life after induction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2005 (estimated)
- Study startOct 2004
- Study completionOct 2008 (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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Health Research Institutes, Taiwan
- Sponsor type
- University, hospital or other
- Collaborators
- Chang Gung Memorial Hospital, National Taiwan University Hospital, Mackay Memorial Hospital, China Medical University Hospital, National Cheng-Kung University Hospital
- Investigators
- Hui-Ju Ch'ang, M.D., Study chair, Pancreatic Cancer Disease Committee of Taiwan Cooperative Oncology GroupLi-Tzong Chen, Ph.D., Study chair, Pancreatic Cancer Disease Committee of Taiwan Cooperative Oncology Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00149578
- Sponsor's protocol ID
- T1204
- Status last verified
- May 2007
- First submitted
- 7 Sep 2005
- Last updated
- 17 May 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Induction Chemotherapy Followed by Concurrent Chemotherapy With Radiotherapy in Locally Advanced Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT00149578
- Acronym / sponsor ID
- T1204
- Conditions
- Pancreatic Cancer
- Keywords
- pancreatic cancer, gemcitabine, oxaliplatin, 5-Fluorouracil, radiation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- National Health Research Institutes, TaiwanUniversity, hospital or other
- Collaborators
- Chang Gung Memorial Hospital, National Taiwan University Hospital, Mackay Memorial Hospital, China Medical University Hospital, National Cheng-Kung University Hospital
- Study start
- Oct 2004
- Study completion
- Oct 2008 (estimated)
- First posted
- 8 Sep 2005 (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.
Induction chemotherapy will be administered every 2 weeks for 6 cycles (about 3 months). Patients who have radiological evidence of progressive disease will be shifted to salvage chemotherapy. Patients who have responsive or stable disease after induction chemotherapy will receive concurrent chemoradiotherapy 3-4 weeks after the last dose of induction chemotherapy. Surgical evaluation will be performed 4-6 weeks after the completion of chemoradiotherapy. Patients who have resectable disease will undergo surgical resection. Postoperative adjuvant chemotherapy with GOFL for 6 cycles will be given for those who have curative resection. Patients who still have unresectable disease or non-curative resection will receive systemic chemotherapy of GOFL till disease progression or unacceptable toxicity.
Detailed description
Induction chemotherapy will be administered on a biweekly basis. Reported adverse events and potential risks for gemcitabine, oxaliplatin, 5-FU and leucovorin are described in Section 6. Appropriate dose modifications for are described in Section 5. No investigational or commercial agents or therapies other than those described below may be administered with the intent to treat the patient's malignancy.
4.1.1 Treatment schedule of induction chemotherapy
For each dose of GOFL chemotherapy, intravenous infusion of gemcitabine at a fixed rate of 10 mg/m2/min will be immediately followed by a 2-hour intravenous infusion of oxaliplatin and then a 48-hour intravenous infusion of 5-FU and leucovorin.
4.1.2 Premedication before chemotherapy
Patients will receive 4mg of dexamethasone and anti-histamine and appropriate anti-emetics (serotonin antagonists) before each dose of chemotherapy.
4.2 Supportive Care Guidelines
Prophylactic G-CSF or GM-CSF will not be routinely used in this study. In case of febrile neutropenia, patients should be treated with appropriate antibiotics. Therapeutic G-CSF may be used at the discretion of attending physicians
4.3 Duration of Induction Chemotherapy
In the absence of treatment delays due to adverse events, treatment may continue for 6 cycles or until one of the following criteria applies:
C Disease progression, C Intercurrent illness that prevents further administration of treatment, C Unacceptable adverse events(s), C Patient decides to withdraw from the study, or C General or specific changes in the patient's condition render the patient unacceptable for further treatment in the judgment of the investigator.
4.4 Agents and Radiation Administration during Concurrent Chemoradiotherapy
4.4.1 Treatment schedule during concurrent chemoradiotherapy
4.4.1.1 Patient selection
Patients were evaluated after 6 cycles of induction chemotherapy. Patients who have progressive disease either due to distant metastasis or locoregional progression will be given salvage systemic chemotherapy and will not be enrolled into concurrent chemoradiotherapy. Patients who achieve complete remission, partial remission or stable disease will be enrolled into 2nd phase of the study, concurrent chemoradiotherapy, 3-4 weeks after the last dose of induction chemotherapy.
4.4.2 Study Agents
Gemcitabine 400mg/m2 will be dissolved in 250ml normal saline and infused intravenously at a fixed rate of 10mg/m2/min for 40 mins.
4.4.1.2 Treatment schedule
Gemcitabine 400mg/m2 in 250ml normal saline will be iv infused for 40mins, 2hrs before RT on day 1, 8, 15, 22, 29, 36. Radiation will be given 180cGy per day, 5 days a week for 28 fractions to totally 5040cGy.
4.4.1.3 Premedication for concurrent chemoradiotherapy
Patients were given dexamethasone 2mg orally three times a day (tid) from the morning of their first radiotherapy fraction. The prophylactic dexamethasone will be continued until after they had received their fifth radiation treatment. Therefore, depending on the day of the week the patients started treatment, dexamethasone will be taken for 5 to 7 days. All patients will be issued with rescue medication, prochlorperazine 10mg every 6 hours orally if they develop nausea and vomiting. If patients still have nausea and/or vomiting during treatment of dexamethasone and prochlorperazine or after the fifth day of radiotherapy, ondansetron 8mg orally or iv one to three times per day or granisetron 1mg per os or iv once everyday 30mins before radiotherapy should be given.
4.4.3 Radiation
4.4.3.1 Radiation technique
Radiation should be performed by high-energy linear accelerators. Three-dimensional radiation treatment planning was used in all cases. Patients will be immobilized in a foam cradle in a supine position, and the treatment planning CT was obtained. Tumor mapping should be performed according to treatment planning CT and the diagnostic CT before induction chemotherapy. Treatment planning was performed with the isocenter calculated at 100% and the 95% line encompassing the planning target volume. The spinal cord was limited to 4600cGy. If one kidney was to receive more than 20Gy then more than 90% of the remaining kidney was excluded from the primary beam. Generally, a three-field no-axial beam arrangement (opposed lateral with an anterior-inferior oblique) was used.
4.4.3.2 Radiation volume
The gross tumor volume is the primary tumor identifiable on CT scan before induction chemotherapy. The clinical target volume was defined as the gross tumor volume plus 0.5cm. The planning target volume was the clinical target volume plus 0.5cm for daily patient set-up variation. No prophylactic nodal irradiation will be given.
4.4.3.3 Radiation dosage
A total dose of 5040cGy in 28 fractions, 180cGy per fraction, one fraction per day, 5 days per week, will be given.
4.5 Surgery
4.5.1 Surgical evaluation
Patients completed induction chemotherapy and concurrent chemoradiotherapy will be evaluated for surgical resection. If there is evidence of distant metastasis, surgery will not be arranged. The feasibility of surgical resection will be evaluated by qualified surgeon according to contrast-enhanced abdominal CT or MRI. Laparoscope is optional for pre-surgical evaluation.
4.5.1.1 Resectable l No distant metastases l Clear fat plane around celiac and superior mesenteric arteries (SMA) l Patent superior mesenteric vein (SMV)/portal vein 4.5.1.2 Borderline resectable l Severe unilateral SMV/portal impingement l Tumor abutment on SMA l Gastroduodenal artery (GDA) encasement up to origin at hepatic artery l Colon or mesocolon invasion l Adrenal, colon or mesocolon, or kidney invasion 4.5.1.3 Unresectable l Distant metastases l SMA, celiac encasement l SMV/portal occlusion l Aortic, inferior vena cava (IVC) invasion or encasement l Invasion of SMV below transverse mesocolon l Rib, vertebral invasion
4.5.2 Treatment schedule of surgery
Surgery will be performed within 4-6 weeks after chemoradiotherapy complete.
4.5.3 Surgical technique
Patients whose tumor are considered to be resectable will undergo laparotomy. If complete surgical resection is feasible, optimal surgery will be performed. If complete surgical resection is impossible, biopsy with or without palliative surgery (eg. bypass surgery) may be performed. 4.6 Adjuvant/Maintenance Chemotherapy
4.6.1 Treatment schedule
Patients who have curative surgical resection will receive 6 cycles of adjuvant GOFL chemotherapy within 4 weeks after surgery and then followed up until tumor progression. Patients who are not feasible for curative resection, will receive continued chemotherapy of GOFL 3-4 weeks after chemoradiotherapy complete. The regimen will continue till disease progression. Patients who develop progressive disease during GOFL will shift to salvage chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Patients must have histologically or cytologically confirmed adenocarcinoma of pancreas.
- Patients must have locally advanced pancreatic cancer.
- Patients must have unresectable pancreatic cancer evaluated by radiologist and/or surgeon according to either abdominal CT or MRI, or intra-operative findings.
- Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >20 mm with conventional techniques or as >10 mm with spiral CT scan. See section 8.2 for the evaluation of measurable disease.
- Age >20 years. Because no dosing or adverse event data are currently available on the use of study agents in patients <20 years of age, children are excluded from this study.
Key exclusion criteria (9 listed)
- Patients with distant metastases are not eligible.
- Patients may not be receiving any other investigational agents.
- Patients who have had prior chemotherapy or radiotherapy are not eligible.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agents used in the study.
- Patients who have above grade II peripheral neuropathy.
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 |
|---|---|---|
| Gemcitabine Oxaliplatin 5FU and Leucovorin | Drug | – |
Primary outcome
The primary end point is to evaluate the local response rate after induction chemotherapy and concurrent chemoradiotherapy in locally advanced pancreatic cancer.
chemotherapy and concurrent chemoradiotherapy in locally advanced pancreatic cancer. .
1 secondary outcome
The secondary end points are to evaluate the distant metastasis rate and time to tumor progression, overall survival time and quality of life after induction
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2007.
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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.
Hui-Ju Ch'ang, M.D. study chair
Pancreatic Cancer Disease Committee of Taiwan Cooperative Oncology Group
Li-Tzong Chen, Ph.D. study chair
Pancreatic Cancer Disease Committee of Taiwan Cooperative Oncology Group
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Gemcitabine Oxaliplatin 5FU and Leucovorin in people with Pancreatic Cancer, run by National Health Research Institutes, Taiwan at 2 sites in Taiwan.
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 21 inclusion and 9 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 17 May 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Taiwan. 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 Yueh-Ling Ho, RN (886-2-26534401 ext. 25155, ylho@nhri.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary end point is to evaluate the local response rate after induction chemotherapy and concurrent chemoradiotherapy in locally advanced pancreatic cancer.. The study lists 2 primary outcomes in all. 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 17 May 2007.