Pancreatic CancerNCT02704143
Combination of SBRT With Sequential S-1 for Treating Locally Advanced Pancreatic Cancer
A study testing combination of Cyberknife with S-1 in people with Pancreatic Cancer, run by Changhai Hospital at 1 site in China.
Trial summary
The safety and efficacy of combination of SBRT with sequential S-1 in treating patients with locally advanced pancreatic cancer and poor medical conditions will be evaluated. 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?
- combination of Cyberknife with S-1
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteChina
- Study dates
- Feb 2016to May 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Locally advanced pancreatic cancer proved by CT or MRI and biopsy
- Without any other treatment before SBRT
- A life expectancy of >3months
- ECOG: 2 or 3 points
- Age of more than 18 years old
- Blood routine examination: Absolute neutrophil count (ANC) ≥ 1.5 ×10^9 cells/L, leukocyte count≥ 3.5 ×10^9 cells/L, platelets ≥ 70×10^9 cells/L, hemoglobin ≥ 8.0 g/dl
Show all 9Show fewer
- Liver and kidney function tests: Albumin > 2.5 g/dL, total bilirubin < 3 mg/dL, creatinine < 2.0 mg/dL, AST<2.5 × ULN(Upper Limit of Normal)(0-64U/L), ALT<2.5 × ULN(0-64U/L)
- INR < 2 (0.9-1.1)
- Ability of the research subject or authorized legal representative to understand and the willingness to sign a written informed consent document.
Who cannot join
- Prior surgery, chemotherapy or radiation for the pancreatic cancer
- Evidences of metastatic disease such as nodal or distant metastases by abdomen CT and chest CT or FDG PET-CT
- Contraindication to receiving radiotherapy
- ECOG: 0-1 point
- Age<18
- Abnormal results of blood routine examinations and liver and kidney tests
Show all 13Show fewer
- Patients with active inflammatory bowel diseases or peptic ulcer
- Gastrointestinal bleeding or perforation within 6 months
- Heart failure: NYHA III-IV
- Women who are pregnant
- Participation in another clinical treatment trial while on study
- Patients in whom fiducial implantation was not possible
- Inability of the research subject or authorized legal representative to understand and the willingness to sign a written informed consent document.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Stereotactic Body Radiation Therapy With Sequential S-1 for Patients With Locally Advanced Pancreatic Cancer and Poor Medical Conditions --a Phase II Clinical Trial
The safety and efficacy of combination of SBRT with sequential S-1 in treating patients with locally advanced pancreatic cancer and poor medical conditions will be evaluated.
Read the detailed description
Although the incidence rate of pancreatic cancer is not as high as that of other gastrointestinal carcinoma in China, the cancer mortalities of males and females ranked the sixth and seventh respectively in 2013, with a surprising low 5-year survival rate (<5%). Only 15%-20% patients are suitable for surgeries among those first diagnosed with pancreatic cancer and the 5-year survival rate of patients with R0 resection is still less than 20%.
Therefore, better efficacy is not available via surgeries alone resulting in great emphasis on adjuvant chemoradiotherapy. In 1997, gemcitabine was confirmed to be the standard chemotherapy for pancreatic cancer. However, it has not been proved that gemcitabine significantly improved prognosis in long term follow-up while some patients are refractory to gemcitabine. Hence, development of more effective chemotherapy is urgent.
S-1 is the prodrug of 5-fluorouracil (5-FU), comprised of tegafur, gimeracil (dihydropyrimidine dehydrogenase inhibitor) and oteracil (the inhibitor of phosphorylation in gastrointestinal tract) with a ratio of 1:0.4:1. The first phase II clinical trials showed good clinical efficacy with S-1.Moreover, Ueno et al. identified better objective response rates with S-1 than those with gemcitabine. Besides, S-1 is not inferior to gemcitabine regarding to overall survival rates and progression free survival rates. And significant improvement of progression free survival rates can be achieved by combination of S-1 and gemcitabine. There was no difference between incidence rates of adverse effects of S-1 and gemcitabine, with more gastrointestinal toxicities with S-1 while more hematologic toxicities with gemcitabine. Therefore, S-1 is an alternative for treating locally advanced or metastatic pancreatic cancer, especially for those resistant to gemcitabine. Although there are no phase III studies on S-1, phase II studies have already shown better disease control rates (52%-58%), median overall survival time (4.5-6.3 months) and tolerable adverse effects in advanced pancreatic cancer resistant to gemcitabine treated with S-1.
Though S-1 is appropriate for advanced pancreatic cancer, it is not superior to gemcitabine with respect to clinical efficacy. In addition, fewer encouraging results are gained with combination of S-1 and other drug. As a result, S-1 combined with radiotherapy is gradually applied in treatment of pancreatic cancer.
5-FU was proved to be radiosensitive thus improving clinical efficacy. S-1 combined with radiotherapy has demonstrated better prognosis with the median overall survival time of 12.9-16.8 months. Furthermore, some patients can be operable after S-1 and radiotherapy.
Compared with conventional radiation, a single-fraction dose and total dose of target volume can be increased in stereotactic body radiation therapy (SBRT). In addition, doses of organs at risk would be reduced, thus effectively improving local control rates and reducing radiation related toxicity. Shorter courses of SBRT also enhance patients' compliance and render the initial of other treatment on schedule possible. Nevertheless, there are few studies focusing on S-1 combined with SBRT for locally advanced pancreatic cancer. Especially for patients with poor medical coonditions, though gemcitabine alone is recommended in the NCCN guideline, S-1 may be a better option due to more adverse effects induced by gemcitabine in Asian. Additionally, local ablative treatment combined with chemotherapy may provide more survival benefits for those patients. Hence, efficacy of combination of S-1 and SBRT needs to be further confirmed. Based on our experience in treating locally advanced pancreatic cancer, SBRT combined with sequential S-1 as the initial treatment for patients with locally advanced pancreatic cancer and poor medical conditions is proposed to evaluate its clinical efficacy.
Study Procedure:
- CyberKnife SBRT body fixation (vacuum-bag) will be used in immobilizing the body, the arms and the legs. Patients will undergo a plain CT as well as an enhanced pancreatic parenchymal CT for radiation treatment planning and target delineation.
- SBRT will be delivered on CyberKnife with Synchrony Respiratory Tracking system. The tumor will be tracked with implanted fiducial markers by Fiducial Tracking System. Treatment will be delivered in 5 fractions within 1 to 2 weeks at the discretion of the investigator.
- A body fixation (vacuum-bag) will be used in immobilizing the body, the arms (both arms are along the body) and the legs.
- The total doses depend on patients' medical conditions, ranging from 35Gy-40Gy/5Fx.
- Patients receive 80 mg of S-1 per square meter of body surface area twice a day for 4 weeks, followed by 2 weeks of rest as one course, which would repeat for six cycles.The initiation of S-1 is one month after SBRT.
- Conditions
- Pancreatic Cancer
- Being tested
- combination of Cyberknife with S-1
- Keywords
- stereotactic body radiation therapy, S-1, locally advanced pancreatic cancer, poor medical conditions
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
combination of Cyberknife with S-1Other
Radiation therapy combined with chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| Combination of Cyberknife with S-1 | Experimental | Patients with locally advanced pancreatic cancer meeting all inclusion criteria will receive combination of Cyberknife with S-1. Receives: Other: combination of Cyberknife with S-1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
One-year Overall Survival Rate
One-year overall survival rate is calculated by the ratio of number of patients surviving more than 1 year to the total number of patients enrolled.
Measured: 1 year
Secondary outcomes (5)
Number of Participants With Acute Toxicities Following SBRT
The acute toxicities are determined by RTOG Acute Radiation Morbidity Scoring Criteria.
Measured: Within 90 days after completion of SBRT
Number of Participants With Late Toxicities Following SBRT
The late toxicities are determined by RTOG/EORTC Late Radiation Morbidity Scoring Criteria.
Measured: 90 days after SBRT
The Median Progression Free Survival Time Will be Determined.
Progression-free survival is the time from the date of enrollment to the confirmation of disease progression at any sites, including local progression or metastasis, or death from any causes, if this occurred before disease progression. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Measured: 3 years
The Quality of Life Will be Analyzed.
The analysis of quality of life is based on The European Organization for Reasearch and Treatment of Cancer (EORTC): Quality of Life Questionnare-Core 30 (QLQ-C30). Higher scores in function domains and global health status indicate better quality of life, while higher scores in symptom domains imply worse quality of life. The scale range of all domains of QLQ-C30 is 0-100 (the minimum and maximum score is 0 and 100 points, respectively).
Measured: 1 years
Median Overall Survival Will be Determined.
Median overall survival is calculated by Kaplan-Meier method.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2016 (estimated)
- Study startFeb 2016
- Primary completionMay 2020
- Study completionMay 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Changhai HospitalThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- stereotactic bodt radiation therapy plus sequential S-1 for locally pancreatic cancer
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhang Huo Jun, Changhai Hospital
- Investigators
- Huo Jun Zhang, MD., PH.D, Principal investigator, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02704143
- Sponsor's protocol ID
- Changhai Hosp
- Status last verified
- Aug 2020
- First submitted
- 1 Mar 2016
- Last updated
- 19 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Siegel R, Naishadham D, Jemal A. Cancer statistics, 2012. CA Cancer J Clin. 2012 Jan-Feb;62(1):10-29. doi: 10.3322/caac.20138. Epub 2012 Jan 4.
PubMed 22237781Sener SF, Fremgen A, Menck HR, Winchester DP. Pancreatic cancer: a report of treatment and survival trends for 100,313 patients diagnosed from 1985-1995, using the National Cancer Database. J Am Coll Surg. 1999 Jul;189(1):1-7. doi: 10.1016/s1072-7515(99)00075-7.
PubMed 10401733Richter A, Niedergethmann M, Sturm JW, Lorenz D, Post S, Trede M. Long-term results of partial pancreaticoduodenectomy for ductal adenocarcinoma of the pancreatic head: 25-year experience. World J Surg. 2003 Mar;27(3):324-9. doi: 10.1007/s00268-002-6659-z. Epub 2003 Feb 27.
PubMed 12607060Tseng JF, Raut CP, Lee JE, Pisters PW, Vauthey JN, Abdalla EK, Gomez HF, Sun CC, Crane CH, Wolff RA, Evans DB. Pancreaticoduodenectomy with vascular resection: margin status and survival duration. J Gastrointest Surg. 2004 Dec;8(8):935-49; discussion 949-50. doi: 10.1016/j.gassur.2004.09.046.
PubMed 15585381Hoyer M, Roed H, Sengelov L, Traberg A, Ohlhuis L, Pedersen J, Nellemann H, Kiil Berthelsen A, Eberholst F, Engelholm SA, von der Maase H. Phase-II study on stereotactic radiotherapy of locally advanced pancreatic carcinoma. Radiother Oncol. 2005 Jul;76(1):48-53. doi: 10.1016/j.radonc.2004.12.022.
PubMed 15990186Burris HA 3rd, Moore MJ, Andersen J, Green MR, Rothenberg ML, Modiano MR, Cripps MC, Portenoy RK, Storniolo AM, Tarassoff P, Nelson R, Dorr FA, Stephens CD, Von Hoff DD. Improvements in survival and clinical benefit with gemcitabine as first-line therapy for patients with advanced pancreas cancer: a randomized trial. J Clin Oncol. 1997 Jun;15(6):2403-13. doi: 10.1200/JCO.1997.15.6.2403.
PubMed 9196156Ueno H, Okusaka T, Ikeda M, Takezako Y, Morizane C. An early phase II study of S-1 in patients with metastatic pancreatic cancer. Oncology. 2005;68(2-3):171-8. doi: 10.1159/000086771. Epub 2005 Jul 4.
PubMed 16006754Ueno H, Ioka T, Ikeda M, Ohkawa S, Yanagimoto H, Boku N, Fukutomi A, Sugimori K, Baba H, Yamao K, Shimamura T, Sho M, Kitano M, Cheng AL, Mizumoto K, Chen JS, Furuse J, Funakoshi A, Hatori T, Yamaguchi T, Egawa S, Sato A, Ohashi Y, Okusaka T, Tanaka M. Randomized phase III study of gemcitabine plus S-1, S-1 alone, or gemcitabine alone in patients with locally advanced and metastatic pancreatic cancer in Japan and Taiwan: GEST study. J Clin Oncol. 2013 May 1;31(13):1640-8. doi: 10.1200/JCO.2012.43.3680. Epub 2013 Apr 1.
PubMed 23547081Morizane C, Okusaka T, Furuse J, Ishii H, Ueno H, Ikeda M, Nakachi K, Najima M, Ogura T, Suzuki E. A phase II study of S-1 in gemcitabine-refractory metastatic pancreatic cancer. Cancer Chemother Pharmacol. 2009 Jan;63(2):313-9. doi: 10.1007/s00280-008-0741-7. Epub 2008 Apr 9.
PubMed 18398614Sudo K, Yamaguchi T, Nakamura K, Denda T, Hara T, Ishihara T, Yokosuka O. Phase II study of S-1 in patients with gemcitabine-resistant advanced pancreatic cancer. Cancer Chemother Pharmacol. 2011 Feb;67(2):249-54. doi: 10.1007/s00280-010-1311-3. Epub 2010 Mar 30.
PubMed 20352216Mizuno N, Yamao K, Komatsu Y, et al. Randomized phase II trial of S-1 versus S-1 plus irinotecan (IRIS) in patients with gemcitabinerefractory pancreatic cancer. J Clin Oncol, 2012, 30 (suppl 34): abstr 263
Okusaka T, Ohkawa S, Isayama H, et al. Randomized phase II trial of S-1 versus S-1 plus oxaliplatin (SOX) in patients with GEM refractory pancreatic cancer. ESMO, 2012, abstract 1437
Ge F, Xu N, Bai Y, Ba Y, Zhang Y, Li F, Xu H, Jia R, Wang Y, Lin L, Xu J. S-1 as monotherapy or in combination with leucovorin as second-line treatment in gemcitabine-refractory advanced pancreatic cancer: a randomized, open-label, multicenter, phase II study. Oncologist. 2014 Nov;19(11):1133-4. doi: 10.1634/theoncologist.2014-0223. Epub 2014 Oct 1.
PubMed 25273077Rich TA, Shepard RC, Mosley ST. Four decades of continuing innovation with fluorouracil: current and future approaches to fluorouracil chemoradiation therapy. J Clin Oncol. 2004 Jun 1;22(11):2214-32. doi: 10.1200/JCO.2004.08.009.
PubMed 15169811Moningi S, Marciscano AE, Rosati LM, Ng SK, Teboh Forbang R, Jackson J, Chang DT, Koong AC, Herman JM. Stereotactic body radiation therapy in pancreatic cancer: the new frontier. Expert Rev Anticancer Ther. 2014 Dec;14(12):1461-75. doi: 10.1586/14737140.2014.952286. Epub 2014 Sep 3.
PubMed 25183386
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stereotactic Body Radiation Therapy With Sequential S-1 for Patients With Locally Advanced Pancreatic Cancer and Poor Medical Conditions --a Phase II Clinical Trial
- ClinicalTrials.gov ID
- NCT02704143
- Acronym / sponsor ID
- Changhai Hosp
- Conditions
- Pancreatic Cancer
- Keywords
- stereotactic body radiation therapy, S-1, locally advanced pancreatic cancer, poor medical conditions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Study start
- Feb 2016 (actual)
- Primary completion
- May 2020 (actual)
- Study completion
- May 2020 (actual)
- First posted
- 9 Mar 2016 (estimated)
- Results
- Posted 17 Jul 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The safety and efficacy of combination of SBRT with sequential S-1 in treating patients with locally advanced pancreatic cancer and poor medical conditions will be evaluated.
Detailed description
Although the incidence rate of pancreatic cancer is not as high as that of other gastrointestinal carcinoma in China, the cancer mortalities of males and females ranked the sixth and seventh respectively in 2013, with a surprising low 5-year survival rate (<5%). Only 15%-20% patients are suitable for surgeries among those first diagnosed with pancreatic cancer and the 5-year survival rate of patients with R0 resection is still less than 20%.
Therefore, better efficacy is not available via surgeries alone resulting in great emphasis on adjuvant chemoradiotherapy. In 1997, gemcitabine was confirmed to be the standard chemotherapy for pancreatic cancer. However, it has not been proved that gemcitabine significantly improved prognosis in long term follow-up while some patients are refractory to gemcitabine. Hence, development of more effective chemotherapy is urgent.
S-1 is the prodrug of 5-fluorouracil (5-FU), comprised of tegafur, gimeracil (dihydropyrimidine dehydrogenase inhibitor) and oteracil (the inhibitor of phosphorylation in gastrointestinal tract) with a ratio of 1:0.4:1. The first phase II clinical trials showed good clinical efficacy with S-1.Moreover, Ueno et al. identified better objective response rates with S-1 than those with gemcitabine. Besides, S-1 is not inferior to gemcitabine regarding to overall survival rates and progression free survival rates. And significant improvement of progression free survival rates can be achieved by combination of S-1 and gemcitabine. There was no difference between incidence rates of adverse effects of S-1 and gemcitabine, with more gastrointestinal toxicities with S-1 while more hematologic toxicities with gemcitabine. Therefore, S-1 is an alternative for treating locally advanced or metastatic pancreatic cancer, especially for those resistant to gemcitabine. Although there are no phase III studies on S-1, phase II studies have already shown better disease control rates (52%-58%), median overall survival time (4.5-6.3 months) and tolerable adverse effects in advanced pancreatic cancer resistant to gemcitabine treated with S-1.
Though S-1 is appropriate for advanced pancreatic cancer, it is not superior to gemcitabine with respect to clinical efficacy. In addition, fewer encouraging results are gained with combination of S-1 and other drug. As a result, S-1 combined with radiotherapy is gradually applied in treatment of pancreatic cancer.
5-FU was proved to be radiosensitive thus improving clinical efficacy. S-1 combined with radiotherapy has demonstrated better prognosis with the median overall survival time of 12.9-16.8 months. Furthermore, some patients can be operable after S-1 and radiotherapy.
Compared with conventional radiation, a single-fraction dose and total dose of target volume can be increased in stereotactic body radiation therapy (SBRT). In addition, doses of organs at risk would be reduced, thus effectively improving local control rates and reducing radiation related toxicity. Shorter courses of SBRT also enhance patients' compliance and render the initial of other treatment on schedule possible. Nevertheless, there are few studies focusing on S-1 combined with SBRT for locally advanced pancreatic cancer. Especially for patients with poor medical coonditions, though gemcitabine alone is recommended in the NCCN guideline, S-1 may be a better option due to more adverse effects induced by gemcitabine in Asian. Additionally, local ablative treatment combined with chemotherapy may provide more survival benefits for those patients. Hence, efficacy of combination of S-1 and SBRT needs to be further confirmed. Based on our experience in treating locally advanced pancreatic cancer, SBRT combined with sequential S-1 as the initial treatment for patients with locally advanced pancreatic cancer and poor medical conditions is proposed to evaluate its clinical efficacy.
Study Procedure:
- CyberKnife SBRT body fixation (vacuum-bag) will be used in immobilizing the body, the arms and the legs. Patients will undergo a plain CT as well as an enhanced pancreatic parenchymal CT for radiation treatment planning and target delineation.
- SBRT will be delivered on CyberKnife with Synchrony Respiratory Tracking system. The tumor will be tracked with implanted fiducial markers by Fiducial Tracking System. Treatment will be delivered in 5 fractions within 1 to 2 weeks at the discretion of the investigator.
- A body fixation (vacuum-bag) will be used in immobilizing the body, the arms (both arms are along the body) and the legs.
- The total doses depend on patients' medical conditions, ranging from 35Gy-40Gy/5Fx.
- Patients receive 80 mg of S-1 per square meter of body surface area twice a day for 4 weeks, followed by 2 weeks of rest as one course, which would repeat for six cycles.The initiation of S-1 is one month after SBRT.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- stereotactic bodt radiation therapy plus sequential S-1 for locally pancreatic cancer
| Arm | Type | Receives |
|---|---|---|
| Combination of Cyberknife with S-1 | Experimental | Other: combination of Cyberknife with S-1Patients with locally advanced pancreatic cancer meeting all inclusion criteria will receive combination of Cyberknife with S-1. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Locally advanced pancreatic cancer proved by CT or MRI and biopsy
- Without any other treatment before SBRT
- A life expectancy of >3months
- ECOG: 2 or 3 points
- Age of more than 18 years old
Key exclusion criteria (13 listed)
- Prior surgery, chemotherapy or radiation for the pancreatic cancer
- Evidences of metastatic disease such as nodal or distant metastases by abdomen CT and chest CT or FDG PET-CT
- Contraindication to receiving radiotherapy
- ECOG: 0-1 point
- Age<18
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 |
|---|---|---|
| combination of Cyberknife with S-1Radiation therapy combined with chemotherapy | Other | Combination of Cyberknife with S-1 |
Primary outcome
One-year Overall Survival Rate
Time frame: 1 year
One-year overall survival rate is calculated by the ratio of number of patients surviving more than 1 year to the total number of patients enrolled.
5 secondary outcomes
Number of Participants With Acute Toxicities Following SBRT
Time frame: Within 90 days after completion of SBRT
Number of Participants With Late Toxicities Following SBRT
Time frame: 90 days after SBRT
The Median Progression Free Survival Time Will be Determined.
Time frame: 3 years
The Quality of Life Will be Analyzed.
Time frame: 1 years
Median Overall Survival Will be Determined.
Time frame: 3 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 22237781Siegel R, Naishadham D, Jemal A. Cancer statistics, 2012. CA Cancer J Clin. 2012 Jan-Feb;62(1):10-29. doi: 10.3322/caac.20138. Epub 2012 Jan 4.
- Background: PubMed 10401733Sener SF, Fremgen A, Menck HR, Winchester DP. Pancreatic cancer: a report of treatment and survival trends for 100,313 patients diagnosed from 1985-1995, using the National Cancer Database. J Am Coll Surg. 1999 Jul;189(1):1-7. doi: 10.1016/s1072-7515(99)00075-7.
- Background: PubMed 12607060Richter A, Niedergethmann M, Sturm JW, Lorenz D, Post S, Trede M. Long-term results of partial pancreaticoduodenectomy for ductal adenocarcinoma of the pancreatic head: 25-year experience. World J Surg. 2003 Mar;27(3):324-9. doi: 10.1007/s00268-002-6659-z. Epub 2003 Feb 27.
- Background: PubMed 15585381Tseng JF, Raut CP, Lee JE, Pisters PW, Vauthey JN, Abdalla EK, Gomez HF, Sun CC, Crane CH, Wolff RA, Evans DB. Pancreaticoduodenectomy with vascular resection: margin status and survival duration. J Gastrointest Surg. 2004 Dec;8(8):935-49; discussion 949-50. doi: 10.1016/j.gassur.2004.09.046.
- Background: PubMed 15990186Hoyer M, Roed H, Sengelov L, Traberg A, Ohlhuis L, Pedersen J, Nellemann H, Kiil Berthelsen A, Eberholst F, Engelholm SA, von der Maase H. Phase-II study on stereotactic radiotherapy of locally advanced pancreatic carcinoma. Radiother Oncol. 2005 Jul;76(1):48-53. doi: 10.1016/j.radonc.2004.12.022.
- Background: PubMed 9196156Burris HA 3rd, Moore MJ, Andersen J, Green MR, Rothenberg ML, Modiano MR, Cripps MC, Portenoy RK, Storniolo AM, Tarassoff P, Nelson R, Dorr FA, Stephens CD, Von Hoff DD. Improvements in survival and clinical benefit with gemcitabine as first-line therapy for patients with advanced pancreas cancer: a randomized trial. J Clin Oncol. 1997 Jun;15(6):2403-13. doi: 10.1200/JCO.1997.15.6.2403.
- Background: PubMed 16006754Ueno H, Okusaka T, Ikeda M, Takezako Y, Morizane C. An early phase II study of S-1 in patients with metastatic pancreatic cancer. Oncology. 2005;68(2-3):171-8. doi: 10.1159/000086771. Epub 2005 Jul 4.
- Background: PubMed 23547081Ueno H, Ioka T, Ikeda M, Ohkawa S, Yanagimoto H, Boku N, Fukutomi A, Sugimori K, Baba H, Yamao K, Shimamura T, Sho M, Kitano M, Cheng AL, Mizumoto K, Chen JS, Furuse J, Funakoshi A, Hatori T, Yamaguchi T, Egawa S, Sato A, Ohashi Y, Okusaka T, Tanaka M. Randomized phase III study of gemcitabine plus S-1, S-1 alone, or gemcitabine alone in patients with locally advanced and metastatic pancreatic cancer in Japan and Taiwan: GEST study. J Clin Oncol. 2013 May 1;31(13):1640-8. doi: 10.1200/JCO.2012.43.3680. Epub 2013 Apr 1.
- Background: PubMed 18398614Morizane C, Okusaka T, Furuse J, Ishii H, Ueno H, Ikeda M, Nakachi K, Najima M, Ogura T, Suzuki E. A phase II study of S-1 in gemcitabine-refractory metastatic pancreatic cancer. Cancer Chemother Pharmacol. 2009 Jan;63(2):313-9. doi: 10.1007/s00280-008-0741-7. Epub 2008 Apr 9.
- Background: PubMed 20352216Sudo K, Yamaguchi T, Nakamura K, Denda T, Hara T, Ishihara T, Yokosuka O. Phase II study of S-1 in patients with gemcitabine-resistant advanced pancreatic cancer. Cancer Chemother Pharmacol. 2011 Feb;67(2):249-54. doi: 10.1007/s00280-010-1311-3. Epub 2010 Mar 30.
- BackgroundMizuno N, Yamao K, Komatsu Y, et al. Randomized phase II trial of S-1 versus S-1 plus irinotecan (IRIS) in patients with gemcitabinerefractory pancreatic cancer. J Clin Oncol, 2012, 30 (suppl 34): abstr 263
- BackgroundOkusaka T, Ohkawa S, Isayama H, et al. Randomized phase II trial of S-1 versus S-1 plus oxaliplatin (SOX) in patients with GEM refractory pancreatic cancer. ESMO, 2012, abstract 1437
- Individual participant dataSharing planned: No
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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.
Huo Jun Zhang, MD., PH.D principal investigator
Changhai Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing combination of Cyberknife with S-1 in people with Pancreatic Cancer, run by Changhai Hospital at 1 site in China.
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 13 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: finished, as of the sponsor's last update on 19 Oct 2020. 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 China. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Jul 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
One-year Overall Survival Rate (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02704143, which also lists 18 linked publications.
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 19 Oct 2020.