Phase ǀ Study on Pancreatic Cancer Treated by CyberKnife

NCT02716207 | Completed

• 1 other identifier: ChanghaiH001
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 2

Brief Summary

The maximum tolerated dose on locally advanced unresectable pancreatic tumor treated with CyberKnife SBRT will be evaluated.

Conditions

Pancreatic Tumor

Keywords

Stereotactic Body Radiotherapy (SBRT); CyberKnife; Dose Escalation

Outcome Measures

Primary Outcomes (1)

• 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.

  2 years

Secondary Outcomes (3)

• The acute toxicities following SBRT will be determined.

  1 year

• The late toxicities following SBRT will be determined.

  1 year

• Pain intensity will be determined.

  1 year

Study Arms (1)

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.

Device: CyberKnife

Interventions

CyberKnife DEVICE

Radiation Therapy

Maximal tolerated dose with CyberKnife

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Changhai Hospital: lead

Study Sites (2)

Huojun Zhang

Shanghai, Shanghai Municipality, +86, China

Location

HuojunZhang

Shanghai, 200433, China

Location

Related Publications (22)

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• Schellenberg 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.

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• Bae 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.

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• Chuong 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.

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  PMID: 21658854 BACKGROUND

• Chang 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.

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• Hoyer 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.

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• Rwigema 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.

  PMID: 20308870 BACKGROUND

• Schellenberg 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.

  PMID: 18395362 BACKGROUND

• Goyal K, Einstein D, Ibarra RA, Yao M, Kunos C, Ellis R, Brindle J, Singh D, Hardacre J, Zhang Y, Fabians J, Funkhouser G, Machtay M, Sanabria JR. Stereotactic body radiation therapy for nonresectable tumors of the pancreas. J Surg Res. 2012 May 15;174(2):319-25. doi: 10.1016/j.jss.2011.07.044. Epub 2011 Sep 5.

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• Kavanagh BD, Schefter TE, Cardenes HR, Stieber VW, Raben D, Timmerman RD, McCarter MD, Burri S, Nedzi LA, Sawyer TE, Gaspar LE. Interim analysis of a prospective phase I/II trial of SBRT for liver metastases. Acta Oncol. 2006;45(7):848-55. doi: 10.1080/02841860600904870.

  PMID: 16982549 BACKGROUND

• Rusthoven KE, Kavanagh BD, Cardenes H, Stieber VW, Burri SH, Feigenberg SJ, Chidel MA, Pugh TJ, Franklin W, Kane M, Gaspar LE, Schefter TE. Multi-institutional phase I/II trial of stereotactic body radiation therapy for liver metastases. J Clin Oncol. 2009 Apr 1;27(10):1572-8. doi: 10.1200/JCO.2008.19.6329. Epub 2009 Mar 2.

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• Kavanagh BD, Pan CC, Dawson LA, Das SK, Li XA, Ten Haken RK, Miften M. Radiation dose-volume effects in the stomach and small bowel. Int J Radiat Oncol Biol Phys. 2010 Mar 1;76(3 Suppl):S101-7. doi: 10.1016/j.ijrobp.2009.05.071.

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• Qing S, Gu L, Zhang H. Phase I study of dose-escalated stereotactic body radiation therapy for locally advanced pancreatic head cancers: Initial clinical results. Cancer Med. 2021 Oct;10(19):6736-6743. doi: 10.1002/cam4.4214. Epub 2021 Aug 18.

  PMID: 34405577 DERIVED

• Qing SW, Ju XP, Cao YS, Zhang HJ. Dose escalation of Stereotactic Body Radiotherapy (SBRT) for locally advanced unresectable pancreatic cancer patients with CyberKnife: protocol of a phase I study. Radiat Oncol. 2017 Jan 9;12(1):6. doi: 10.1186/s13014-016-0760-1.

  PMID: 28069017 DERIVED

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Huo Jun Zhang, MD., PH.D

  Changhai Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Radiation Oncology Department

Study Record Dates

• First Submitted: January 6, 2016
• First Posted: March 23, 2016
• Study Start: March 1, 2016
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: May 14, 2021

Record last verified: 2021-05

Locations

CN (2)