Pancreatic TumorNCT02716207
Phase ǀ Study on Pancreatic Cancer Treated by CyberKnife
A study testing CyberKnife in people with Pancreatic Tumor, run by Changhai Hospital at 2 sites in China.
Trial summary
The maximum tolerated dose on locally advanced unresectable pancreatic tumor treated with CyberKnife SBRT will be evaluated. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pancreatic Tumor
- What is being tested?
- CyberKnife
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 2 sitesChina
- Study dates
- Mar 2016to Dec 2020
- Phase
- Interventional
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Unresectable pancreatic adenocarcinoma or unsuitable/unwilling for resection which is proved by biopsy.
- A life expectancy of >3months
- Eastern Cooperative Oncology Group (ECOG) status ≤2
- Tumor size < 5 cm
- Tumor location: Head of pancreas
- Patients must be able to undergo contrast enhanced CT for planning
Show all 19Show fewer
- Absolute neutrophil count (ANC) ≥ 1.5 ×109 cells/L
- Leukocyte count≥ 3.5 ×109cells/L
- Platelets ≥ 70×109cells/L
- Hemoglobin ≥ 8.0 g/dl
- Albumin > 2.5 g/dL
- Total bilirubin < 3 mg/dL
- Creatinine < 2.0 mg/dL
- INR < 2 (0.9-1.1)
- Aspartate transaminase (AST) <2.5 × Upper Limit of Normal (ULN )(0-64U/L)
- Alanine aminotransferase (ALT) <2.5 × ULN(0-64U/L)
- Both men and women and members of all races and ethnic groups are eligible for this study
- Ability of the research subject or authorized legal representative to understand and the willingness to sign a written informed consent document
- Tumor markers and lab test should be done less than 1 week before recruitment
Who cannot join
- Prior surgery, chemotherapy or radiation for the pancreatic tumor
- Prior radiotherapy to the upper abdomen, evidence of metastatic disease such as nodal or distant metastases by abdomen CT and chest CT or FDG PET-CT
- Contraindication to receiving radiotherapy
- Distance between gross tumor volume (GTV) (lesion) and luminal structures (including liver, stomach, duodenum, small or large bowel) is<5 mm
- Women who are pregnant
- Participation in another clinical treatment trial while on study
- Patients in whom fiducial implantation was not possible
Trial locations and contacts
2 sites in 1 country.
China2 sites
Huojun Zhang
Shanghai, Shanghai Municipality, +86
HuojunZhang
Shanghai, 200433
About this study
Official title: Mono-Center Phase ǀ Study on Dose Escalation of Stereotactic Body Radiotherapy (SBRT) Treating Pancreatic Cancer Patients With CyberKnife
The maximum tolerated dose on locally advanced unresectable pancreatic tumor treated with CyberKnife SBRT will be evaluated.
Read the detailed description
Pancreatic cancer is the fourth-leading cause of cancer-related death in the world. It is characterized by metastatic spread and local failure and seldom detected in its earlier stages. For locally advanced stage pancreatic cancer, the complete surgical removal is hard to achieve.
Stereotactic body radiotherapy (SBRT) with CyberKnife for unresectable pancreatic tumor is a relatively new treatment option made available because of significant improvements in diagnostic imaging and radiation delivery techniques. Different from the conventional radiotherapy, radiation dose is delivered in fewer fractions and higher fractional doses in SBRT. Gurka (1) reported that 14 patients received SBRT with prescription dose of 25 Gy in five fractions with biologically equivalent doses (BED) of α/β=10 in correspondence to 37.5Gy. Grade 1 to 2 gastrointestinal toxicity (no grade 3 or 4 radiation-related toxicities) was observed two weeks after treatment. Two patients had a partial response, and 12 patients were with stable diseases. In the previous dose escalation study, a single fraction up to15 Gy, 20 Gy, 25 Gy which is an equivalent BED10 to 37.5 Gy, 60 Gy, 87.5 Gy respectively is recommended by Koong AC (2) and his team. Even though the local control rate is 100%, the follow up is short and the sample size of 15 patients is relatively small. Moreover, the late toxicity is not investigated. And with single fraction scheme, higher late gastrointestinal (GI) toxicities were reported (2,3,4). In the meanwhile, investigators (5, 6) from South Korea examined that a Dmax of 35Gy and 38Gy in 3 fractions (BED10 to 75.8Gy and 86.1Gy) of SBRT correlated with a 5% and 10% rate of grade 3 of gastroduodenal toxicity for abdominal malignant tumor, respectively.
Chuong (7) used 5 fractions to potentially decrease the risk of late normal tissue injury compared with 1 to 3 fractions commonly used in other institutions. Assuming α/β=3, the BED3 delivered to normal tissue in this study (using a mean 36.4 Gy in 5 fractions to the high dose PTV) was 125 Gy, which is lower than the mean BED3 from other series, the corresponding values from Boston and Stanford were 153.7 Gy (mean, 32.96 Gy in 3 fractions) and 233.3 Gy (mean, 25Gy in 1 fraction), respectively (8, 9). And a relatively lower incidence of grade ≥3 late adverse effects (5.3% VS 9%) was observed.
Since the treatment modality and dose are still under exploratory stage, we propose to conduct a Phase I study determining the maximum tolerated dose of CyberKnife SBRT on dose escalation for the treatment of locally advanced pancreatic tumor based on a 5 fractions treatment regimen. A prescription dose of 35-47.5 Gy in five fractions was chosen, with an equivalent to the traditional dose of 2 Gy in 25-39 fractions of BED10. And this is assumed to be the safe and effective dose for unresectable pancreatic cancer patients.
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.
- Conditions
- Pancreatic Tumor
- Being tested
- CyberKnife
- Keywords
- Stereotactic Body Radiotherapy (SBRT), CyberKnife, Dose Escalation
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CyberKnifeDevice
Radiation Therapy
| Study group | Role | What they receive |
|---|---|---|
| Maximal tolerated dose with CyberKnife | Experimental | SBRT will be delivered in 5 fractions within 1 to 2 weeks by the following schedule: Doses of 7 Gy, 7.5 Gy, 8 Gy, 8.5 Gy, 9 Gy, 9.5 Gy x 5 with BED10 in correspondence to 59.5 Gy, 65.6 Gy, 72 Gy, 78.6 Gy, 85.5 Gy, 92.6 Gy respectively while meeting with normal tissue constraints. A minimum of three patients will be included for each dosage level. And an interval is four weeks between each dose level. In case patient presents III/IV GI toxicity, three additional patients will be included at the same dose level. The Maximal Tolerated Dose will be defined as the dose for which at least 2 patients in 3, or at least 3 patients in 9, will present with a limiting toxicity. Receives: Device: CyberKnife |
What is being measured
The primary outcome is the main question the study is designed to answer.
The maximum tolerated dose will be determined
The maximal tolerated dose will be defined as the dose for which at least 2 patients in 3, or at least 3 patients in 9, will present with a limiting toxicity.
Measured: 2 years
Secondary outcomes (3)
The acute toxicities following SBRT will be determined.
The acute toxicities are determined by RTOG Acute Radiation Morbidity Scoring Criteria.
Measured: 1 year
The late toxicities following SBRT will be determined.
The late toxicities are determined by RTOG/EORTC Late Radiation Morbidity
Measured: 1 year
Pain intensity will be determined.
Pain intensity is assessed by the numeric rating scales 0-10
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2016 (estimated)
- Study startMar 2016
- Primary completionDec 2020
- Study completionDec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Pancreatic TumorStudies 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
- Masking
- None (open label)
- Enrolment
- 16 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
- NCT02716207
- Sponsor's protocol ID
- ChanghaiH001
- Status last verified
- May 2021
- First submitted
- 6 Jan 2016
- Last updated
- 14 May 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Gurka MK, Collins SP, Slack R, Tse G, Charabaty A, Ley L, Berzcel L, Lei S, Suy S, Haddad N, Jha R, Johnson CD, Jackson P, Marshall JL, Pishvaian MJ. Stereotactic body radiation therapy with concurrent full-dose gemcitabine for locally advanced pancreatic cancer: a pilot trial demonstrating safety. Radiat Oncol. 2013 Mar 1;8:44. doi: 10.1186/1748-717X-8-44.
PubMed 23452509Koong AC, Le QT, Ho A, Fong B, Fisher G, Cho C, Ford J, Poen J, Gibbs IC, Mehta VK, Kee S, Trueblood W, Yang G, Bastidas JA. Phase I study of stereotactic radiosurgery in patients with locally advanced pancreatic cancer. Int J Radiat Oncol Biol Phys. 2004 Mar 15;58(4):1017-21. doi: 10.1016/j.ijrobp.2003.11.004.
PubMed 15001240Koong AC, Christofferson E, Le QT, Goodman KA, Ho A, Kuo T, Ford JM, Fisher GA, Greco R, Norton J, Yang GP. Phase II study to assess the efficacy of conventionally fractionated radiotherapy followed by a stereotactic radiosurgery boost in patients with locally advanced pancreatic cancer. Int J Radiat Oncol Biol Phys. 2005 Oct 1;63(2):320-3. doi: 10.1016/j.ijrobp.2005.07.002.
PubMed 16168826Schellenberg D, Kim J, Christman-Skieller C, Chun CL, Columbo LA, Ford JM, Fisher GA, Kunz PL, Van Dam J, Quon A, Desser TS, Norton J, Hsu A, Maxim PG, Xing L, Goodman KA, Chang DT, Koong AC. Single-fraction stereotactic body radiation therapy and sequential gemcitabine for the treatment of locally advanced pancreatic cancer. Int J Radiat Oncol Biol Phys. 2011 Sep 1;81(1):181-8. doi: 10.1016/j.ijrobp.2010.05.006. Epub 2011 May 5.
PubMed 21549517Bae SH, Kim MS, Cho CK, Kang JK, Lee SY, Lee KN, Lee DH, Han CJ, Yang KY, Kim SB. Predictor of severe gastroduodenal toxicity after stereotactic body radiotherapy for abdominopelvic malignancies. Int J Radiat Oncol Biol Phys. 2012 Nov 15;84(4):e469-74. doi: 10.1016/j.ijrobp.2012.06.005.
PubMed 23078899Bae SH, Kim MS, Kim SY, Jang WI, Cho CK, Yoo HJ, Kim KB, Lee DH, Han CJ, Yang KY, Kim SB. Severe intestinal toxicity after stereotactic ablative radiotherapy for abdominopelvic malignancies. Int J Colorectal Dis. 2013 Dec;28(12):1707-13. doi: 10.1007/s00384-013-1717-6. Epub 2013 Jun 18.
PubMed 23775098Chuong MD, Springett GM, Freilich JM, Park CK, Weber JM, Mellon EA, Hodul PJ, Malafa MP, Meredith KL, Hoffe SE, Shridhar R. Stereotactic body radiation therapy for locally advanced and borderline resectable pancreatic cancer is effective and well tolerated. Int J Radiat Oncol Biol Phys. 2013 Jul 1;86(3):516-22. doi: 10.1016/j.ijrobp.2013.02.022. Epub 2013 Apr 5.
PubMed 23562768Mahadevan A, Miksad R, Goldstein M, Sullivan R, Bullock A, Buchbinder E, Pleskow D, Sawhney M, Kent T, Vollmer C, Callery M. Induction gemcitabine and stereotactic body radiotherapy for locally advanced nonmetastatic pancreas cancer. Int J Radiat Oncol Biol Phys. 2011 Nov 15;81(4):e615-22. doi: 10.1016/j.ijrobp.2011.04.045. Epub 2011 Jun 12.
PubMed 21658854Chang DT, Schellenberg D, Shen J, Kim J, Goodman KA, Fisher GA, Ford JM, Desser T, Quon A, Koong AC. Stereotactic radiotherapy for unresectable adenocarcinoma of the pancreas. Cancer. 2009 Feb 1;115(3):665-72. doi: 10.1002/cncr.24059.
PubMed 19117351Hoyer 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 15990186Didolkar MS, Coleman CW, Brenner MJ, Chu KU, Olexa N, Stanwyck E, Yu A, Neerchal N, Rabinowitz S. Image-guided stereotactic radiosurgery for locally advanced pancreatic adenocarcinoma results of first 85 patients. J Gastrointest Surg. 2010 Oct;14(10):1547-59. doi: 10.1007/s11605-010-1323-7. Epub 2010 Sep 14.
PubMed 20839073Mahadevan A, Jain S, Goldstein M, Miksad R, Pleskow D, Sawhney M, Brennan D, Callery M, Vollmer C. Stereotactic body radiotherapy and gemcitabine for locally advanced pancreatic cancer. Int J Radiat Oncol Biol Phys. 2010 Nov 1;78(3):735-42. doi: 10.1016/j.ijrobp.2009.08.046. Epub 2010 Feb 18.
PubMed 20171803Polistina F, Costantin G, Casamassima F, Francescon P, Guglielmi R, Panizzoni G, Febbraro A, Ambrosino G. Unresectable locally advanced pancreatic cancer: a multimodal treatment using neoadjuvant chemoradiotherapy (gemcitabine plus stereotactic radiosurgery) and subsequent surgical exploration. Ann Surg Oncol. 2010 Aug;17(8):2092-101. doi: 10.1245/s10434-010-1019-y. Epub 2010 Mar 12.
PubMed 20224860Rwigema JC, Parikh SD, Heron DE, Howell M, Zeh H, Moser AJ, Bahary N, Quinn A, Burton SA. Stereotactic body radiotherapy in the treatment of advanced adenocarcinoma of the pancreas. Am J Clin Oncol. 2011 Feb;34(1):63-9. doi: 10.1097/COC.0b013e3181d270b4.
PubMed 20308870Schellenberg D, Goodman KA, Lee F, Chang S, Kuo T, Ford JM, Fisher GA, Quon A, Desser TS, Norton J, Greco R, Yang GP, Koong AC. Gemcitabine chemotherapy and single-fraction stereotactic body radiotherapy for locally advanced pancreatic cancer. Int J Radiat Oncol Biol Phys. 2008 Nov 1;72(3):678-86. doi: 10.1016/j.ijrobp.2008.01.051. Epub 2008 Apr 18.
PubMed 18395362
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mono-Center Phase ǀ Study on Dose Escalation of Stereotactic Body Radiotherapy (SBRT) Treating Pancreatic Cancer Patients With CyberKnife
- ClinicalTrials.gov ID
- NCT02716207
- Acronym / sponsor ID
- ChanghaiH001
- Conditions
- Pancreatic Tumor
- Keywords
- Stereotactic Body Radiotherapy (SBRT), CyberKnife, Dose Escalation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Dec 2020 (actual)
- Study completion
- Dec 2020 (actual)
- First posted
- 23 Mar 2016 (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 maximum tolerated dose on locally advanced unresectable pancreatic tumor treated with CyberKnife SBRT will be evaluated.
Detailed description
Pancreatic cancer is the fourth-leading cause of cancer-related death in the world. It is characterized by metastatic spread and local failure and seldom detected in its earlier stages. For locally advanced stage pancreatic cancer, the complete surgical removal is hard to achieve.
Stereotactic body radiotherapy (SBRT) with CyberKnife for unresectable pancreatic tumor is a relatively new treatment option made available because of significant improvements in diagnostic imaging and radiation delivery techniques. Different from the conventional radiotherapy, radiation dose is delivered in fewer fractions and higher fractional doses in SBRT. Gurka (1) reported that 14 patients received SBRT with prescription dose of 25 Gy in five fractions with biologically equivalent doses (BED) of α/β=10 in correspondence to 37.5Gy. Grade 1 to 2 gastrointestinal toxicity (no grade 3 or 4 radiation-related toxicities) was observed two weeks after treatment. Two patients had a partial response, and 12 patients were with stable diseases. In the previous dose escalation study, a single fraction up to15 Gy, 20 Gy, 25 Gy which is an equivalent BED10 to 37.5 Gy, 60 Gy, 87.5 Gy respectively is recommended by Koong AC (2) and his team. Even though the local control rate is 100%, the follow up is short and the sample size of 15 patients is relatively small. Moreover, the late toxicity is not investigated. And with single fraction scheme, higher late gastrointestinal (GI) toxicities were reported (2,3,4). In the meanwhile, investigators (5, 6) from South Korea examined that a Dmax of 35Gy and 38Gy in 3 fractions (BED10 to 75.8Gy and 86.1Gy) of SBRT correlated with a 5% and 10% rate of grade 3 of gastroduodenal toxicity for abdominal malignant tumor, respectively.
Chuong (7) used 5 fractions to potentially decrease the risk of late normal tissue injury compared with 1 to 3 fractions commonly used in other institutions. Assuming α/β=3, the BED3 delivered to normal tissue in this study (using a mean 36.4 Gy in 5 fractions to the high dose PTV) was 125 Gy, which is lower than the mean BED3 from other series, the corresponding values from Boston and Stanford were 153.7 Gy (mean, 32.96 Gy in 3 fractions) and 233.3 Gy (mean, 25Gy in 1 fraction), respectively (8, 9). And a relatively lower incidence of grade ≥3 late adverse effects (5.3% VS 9%) was observed.
Since the treatment modality and dose are still under exploratory stage, we propose to conduct a Phase I study determining the maximum tolerated dose of CyberKnife SBRT on dose escalation for the treatment of locally advanced pancreatic tumor based on a 5 fractions treatment regimen. A prescription dose of 35-47.5 Gy in five fractions was chosen, with an equivalent to the traditional dose of 2 Gy in 25-39 fractions of BED10. And this is assumed to be the safe and effective dose for unresectable pancreatic cancer patients.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Maximal tolerated dose with CyberKnife | Experimental | Device: CyberKnifeSBRT will be delivered in 5 fractions within 1 to 2 weeks by the following schedule: Doses of 7 Gy, 7.5 Gy, 8 Gy, 8.5 Gy, 9 Gy, 9.5 Gy x 5 with BED10 in correspondence to 59.5 Gy, 65.6 Gy, 72 Gy, 78.6 Gy, 85.5 Gy, 92.6 Gy respectively while meeting with normal tissue constraints. A minimum of three patients will be included for each dosage level. And an interval is four weeks between each dose level. In case patient presents III/IV GI toxicity, three additional patients will be included at the same dose level. The Maximal Tolerated Dose will be defined as the dose for which at least 2 patients in 3, or at least 3 patients in 9, will present with a limiting toxicity. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Unresectable pancreatic adenocarcinoma or unsuitable/unwilling for resection which is proved by biopsy.
- A life expectancy of >3months
- Eastern Cooperative Oncology Group (ECOG) status ≤2
- Tumor size < 5 cm
- Tumor location: Head of pancreas
Key exclusion criteria (7 listed)
- Prior surgery, chemotherapy or radiation for the pancreatic tumor
- Prior radiotherapy to the upper abdomen, evidence of metastatic disease such as nodal or distant metastases by abdomen CT and chest CT or FDG PET-CT
- Contraindication to receiving radiotherapy
- Distance between gross tumor volume (GTV) (lesion) and luminal structures (including liver, stomach, duodenum, small or large bowel) is<5 mm
- Women who are pregnant
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 |
|---|---|---|
| CyberKnifeRadiation Therapy | Device | Maximal tolerated dose with CyberKnife |
Primary outcome
The maximum tolerated dose will be determined
Time frame: 2 years
The maximal tolerated dose will be defined as the dose for which at least 2 patients in 3, or at least 3 patients in 9, will present with a limiting toxicity.
3 secondary outcomes
The acute toxicities following SBRT will be determined.
Time frame: 1 year
The late toxicities following SBRT will be determined.
Time frame: 1 year
Pain intensity will be determined.
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2021.
- Background: PubMed 23452509Gurka MK, Collins SP, Slack R, Tse G, Charabaty A, Ley L, Berzcel L, Lei S, Suy S, Haddad N, Jha R, Johnson CD, Jackson P, Marshall JL, Pishvaian MJ. Stereotactic body radiation therapy with concurrent full-dose gemcitabine for locally advanced pancreatic cancer: a pilot trial demonstrating safety. Radiat Oncol. 2013 Mar 1;8:44. doi: 10.1186/1748-717X-8-44.
- Background: PubMed 15001240Koong AC, Le QT, Ho A, Fong B, Fisher G, Cho C, Ford J, Poen J, Gibbs IC, Mehta VK, Kee S, Trueblood W, Yang G, Bastidas JA. Phase I study of stereotactic radiosurgery in patients with locally advanced pancreatic cancer. Int J Radiat Oncol Biol Phys. 2004 Mar 15;58(4):1017-21. doi: 10.1016/j.ijrobp.2003.11.004.
- Background: PubMed 16168826Koong AC, Christofferson E, Le QT, Goodman KA, Ho A, Kuo T, Ford JM, Fisher GA, Greco R, Norton J, Yang GP. Phase II study to assess the efficacy of conventionally fractionated radiotherapy followed by a stereotactic radiosurgery boost in patients with locally advanced pancreatic cancer. Int J Radiat Oncol Biol Phys. 2005 Oct 1;63(2):320-3. doi: 10.1016/j.ijrobp.2005.07.002.
- Background: PubMed 21549517Schellenberg D, Kim J, Christman-Skieller C, Chun CL, Columbo LA, Ford JM, Fisher GA, Kunz PL, Van Dam J, Quon A, Desser TS, Norton J, Hsu A, Maxim PG, Xing L, Goodman KA, Chang DT, Koong AC. Single-fraction stereotactic body radiation therapy and sequential gemcitabine for the treatment of locally advanced pancreatic cancer. Int J Radiat Oncol Biol Phys. 2011 Sep 1;81(1):181-8. doi: 10.1016/j.ijrobp.2010.05.006. Epub 2011 May 5.
- Background: PubMed 23078899Bae SH, Kim MS, Cho CK, Kang JK, Lee SY, Lee KN, Lee DH, Han CJ, Yang KY, Kim SB. Predictor of severe gastroduodenal toxicity after stereotactic body radiotherapy for abdominopelvic malignancies. Int J Radiat Oncol Biol Phys. 2012 Nov 15;84(4):e469-74. doi: 10.1016/j.ijrobp.2012.06.005.
- Background: PubMed 23775098Bae SH, Kim MS, Kim SY, Jang WI, Cho CK, Yoo HJ, Kim KB, Lee DH, Han CJ, Yang KY, Kim SB. Severe intestinal toxicity after stereotactic ablative radiotherapy for abdominopelvic malignancies. Int J Colorectal Dis. 2013 Dec;28(12):1707-13. doi: 10.1007/s00384-013-1717-6. Epub 2013 Jun 18.
- Background: PubMed 23562768Chuong MD, Springett GM, Freilich JM, Park CK, Weber JM, Mellon EA, Hodul PJ, Malafa MP, Meredith KL, Hoffe SE, Shridhar R. Stereotactic body radiation therapy for locally advanced and borderline resectable pancreatic cancer is effective and well tolerated. Int J Radiat Oncol Biol Phys. 2013 Jul 1;86(3):516-22. doi: 10.1016/j.ijrobp.2013.02.022. Epub 2013 Apr 5.
- Background: PubMed 21658854Mahadevan A, Miksad R, Goldstein M, Sullivan R, Bullock A, Buchbinder E, Pleskow D, Sawhney M, Kent T, Vollmer C, Callery M. Induction gemcitabine and stereotactic body radiotherapy for locally advanced nonmetastatic pancreas cancer. Int J Radiat Oncol Biol Phys. 2011 Nov 15;81(4):e615-22. doi: 10.1016/j.ijrobp.2011.04.045. Epub 2011 Jun 12.
- Background: PubMed 19117351Chang DT, Schellenberg D, Shen J, Kim J, Goodman KA, Fisher GA, Ford JM, Desser T, Quon A, Koong AC. Stereotactic radiotherapy for unresectable adenocarcinoma of the pancreas. Cancer. 2009 Feb 1;115(3):665-72. doi: 10.1002/cncr.24059.
- 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 20839073Didolkar MS, Coleman CW, Brenner MJ, Chu KU, Olexa N, Stanwyck E, Yu A, Neerchal N, Rabinowitz S. Image-guided stereotactic radiosurgery for locally advanced pancreatic adenocarcinoma results of first 85 patients. J Gastrointest Surg. 2010 Oct;14(10):1547-59. doi: 10.1007/s11605-010-1323-7. Epub 2010 Sep 14.
- Background: PubMed 20171803Mahadevan A, Jain S, Goldstein M, Miksad R, Pleskow D, Sawhney M, Brennan D, Callery M, Vollmer C. Stereotactic body radiotherapy and gemcitabine for locally advanced pancreatic cancer. Int J Radiat Oncol Biol Phys. 2010 Nov 1;78(3):735-42. doi: 10.1016/j.ijrobp.2009.08.046. Epub 2010 Feb 18.
- Individual participant dataSharing planned: Undecided
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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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CyberKnife in people with Pancreatic Tumor, run by Changhai Hospital at 2 sites 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 19 inclusion and 7 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 14 May 2021. 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The maximum tolerated dose will be determined (time frame: 2 years). 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 NCT02716207, which also lists 22 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 14 May 2021.