Combination of SBRT With Sequential S-1 for Treating Locally Advanced Pancreatic Cancer

NCT02704143 | Completed Results

• 1 other identifier: Changhai Hosp
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pancreatic Cancer

Keywords

stereotactic body radiation therapy; S-1; locally advanced pancreatic cancer; poor medical conditions

Outcome Measures

Primary Outcomes (1)

• 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.

  1 year

Secondary Outcomes (5)

• Number of Participants With Acute Toxicities Following SBRT

  Within 90 days after completion of SBRT

• Number of Participants With Late Toxicities Following SBRT

  90 days after SBRT

• The Median Progression Free Survival Time Will be Determined.

  3 years

• The Quality of Life Will be Analyzed.

  1 years

• Median Overall Survival Will be Determined.

  3 years

Study Arms (1)

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.

Other: combination of Cyberknife with S-1

Interventions

combination of Cyberknife with S-1 OTHER

Radiation therapy combined with chemotherapy

Combination of Cyberknife with S-1

Eligibility Criteria

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

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Changhai Hospital: lead

Study Sites (1)

Changhai hospital

Shanghai, Shanghai Municipality, 200433, China

Location

Related Publications (18)

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  BACKGROUND

• 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

  BACKGROUND

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• Zhu X, Cao Y, Lu M, Zhao X, Jiang L, Ye Y, Ju X, Zhang H. Stereotactic body radiation therapy with sequential S-1 for patients with locally advanced pancreatic cancer and poor performance status: An open-label, single-arm, phase 2 trial. Radiother Oncol. 2021 Sep;162:178-184. doi: 10.1016/j.radonc.2021.07.009. Epub 2021 Jul 16.

  PMID: 34274393 DERIVED

• Zhu X, Ju X, Cao F, Fang F, Qing S, Shen Y, Jia Z, Cao Y, Zhang H. Safety and efficacy of stereotactic body radiation therapy combined with S-1 simultaneously followed by sequential S-1 as an initial treatment for locally advanced pancreatic cancer (SILAPANC) trial: study design and rationale of a phase II clinical trial. BMJ Open. 2016 Dec 1;6(12):e013220. doi: 10.1136/bmjopen-2016-013220.

  PMID: 27909037 DERIVED

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

S 1 (combination)

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

Lacks of comparison of gemcitabine alone or palliative radiotherapy recommended in NCCN guideline.

Results Point of Contact

• Title: Dr. Huojun Zhang
• Organization: Changhai Hospital affiliated to Navy Medical University

chyyzhj@163.com

86-021-31162207

Study Officials

• Huo Jun Zhang, MD., PH.D

  Changhai Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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

Model Details: stereotactic bodt radiation therapy plus sequential S-1 for locally pancreatic cancer

Study Record Dates

• First Submitted: March 1, 2016
• First Posted: March 9, 2016
• Study Start: February 1, 2016
• Primary Completion: May 1, 2020
• Study Completion: May 1, 2020
• Last Updated: October 19, 2020
• Results First Posted: July 17, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)