Clinical trial · Interventional
Phase ǀ Study on Pancreatic Cancer Treated by CyberKnife
Mono-Center Phase ǀ Study on Dose Escalation of Stereotactic Body Radiotherapy (SBRT) Treating Pancreatic Cancer Patients With CyberKnife
NCT02716207CI-TRIAL-00051806completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The maximum tolerated dose on locally advanced unresectable pancreatic tumor treated with CyberKnife SBRT will be evaluated.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Tumor | Pancreatic Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CyberKnife | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Maximal tolerated dose with CyberKnife
- description
- 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.
- interventionNames
- Device: CyberKnife
Primary outcomes (1)
- measure
- The maximum tolerated dose will be determined
- timeFrame
- 2 years
- description
- 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.
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * 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 * 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 Exclusion Criteria: * 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
References
Publications (22)
- BACKGROUNDGurka 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. PMID 23452509
- BACKGROUNDKoong 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. PMID 15001240
- BACKGROUNDKoong 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. PMID 16168826
- BACKGROUNDSchellenberg 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. PMID 21549517
- BACKGROUNDBae 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. PMID 23078899
- BACKGROUNDBae 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.