Different Patterns of Target Delineation in SBRT for Locally Advanced Pancreatic Cancer

Sponsor

Changhai Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT04699539

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

2.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to compare the efficacy and safety of two target delineation methods in SBRT for LAPC, so as to determine whether the target delineation method based on recurrence pattern can obtain better survival benefits.

Condition or Disease	Intervention/Treatment	Phase
Treatment	Radiation: SBRT Drug: Chemotherapy	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

86 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

GTV Uniform Expansion to Form PTV vs. Non-uniform Expansion to Form PTV Based on Recurrence Pattern in SBRT of Locally Advanced Pancreatic Cancer: a Phase II Clinical Prospective Study

Actual Study Start Date :

Mar 31, 2021

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm A GTV uniform expansion to form PTV in SBRT combined with Gemcitabine + albumin-bound paclitaxel or S-1.	Radiation: SBRT SBRT: in 5-6fractions with Cyberknife. Drug: Chemotherapy Gemcitabine (1000mg/m2，d1, 8) + albumin-bound paclitaxel (125mg/m2，d1, 8) or single-agent oral S-1 (60-120 mg/ daily, d1-14) , repeat every 3 weeks.
Experimental: Arm B GTV non-uniform expansion to form PTV in SBRT combined with Gemcitabine + albumin-bound paclitaxel or S-1.	Radiation: SBRT SBRT: in 5-6fractions with Cyberknife. Drug: Chemotherapy Gemcitabine (1000mg/m2，d1, 8) + albumin-bound paclitaxel (125mg/m2，d1, 8) or single-agent oral S-1 (60-120 mg/ daily, d1-14) , repeat every 3 weeks.

Arm

Intervention/Treatment

Experimental: Arm A

GTV uniform expansion to form PTV in SBRT combined with Gemcitabine + albumin-bound paclitaxel or S-1.

Radiation: SBRT

SBRT: in 5-6fractions with Cyberknife.

Drug: Chemotherapy

Gemcitabine (1000mg/m2，d1, 8) + albumin-bound paclitaxel (125mg/m2，d1, 8) or single-agent oral S-1 (60-120 mg/ daily, d1-14) , repeat every 3 weeks.

Experimental: Arm B

GTV non-uniform expansion to form PTV in SBRT combined with Gemcitabine + albumin-bound paclitaxel or S-1.

Radiation: SBRT

SBRT: in 5-6fractions with Cyberknife.

Drug: Chemotherapy

Gemcitabine (1000mg/m2，d1, 8) + albumin-bound paclitaxel (125mg/m2，d1, 8) or single-agent oral S-1 (60-120 mg/ daily, d1-14) , repeat every 3 weeks.

Outcome Measures

Primary Outcome Measures

1-year Local Control Rate (1y-LCR) [1-year]
Local Control Rate

Secondary Outcome Measures

The Probability of gastrointestinal (GI) Toxicity [1-year]
gastrointestinal toxicity
1-year Disease Progression-Free-Survival (DPFS) [1-year]
Disease Progression-Free-Survival
Overall Survival(OS) [1-year]
Overall Survival

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age 18-75
Patients with a pathological diagnosis of pancreatic ductal adenocarcinoma or clinical diagnosis of pancreatic cancer after clinical multiple disciplinary team
Patients with a clinical staging of locally advanced pancreatic cancer
No anti-tumor treatment related to pancreas before SBRT
Performance status is acceptable, ECOG score is 0 or 1
Patients who voluntarily accepted the clinical trial program after informing the existing treatment plan

Exclusion Criteria:

Patients who have previously received relevant treatments in the pancreas and its surrounding areas, such as radiotherapy, chemotherapy, and local treatment
Severe liver and kidney dysfunction
Obstructive jaundice
Moderate or mass ascites
Patients with other malignant tumors, acute infection or other severe infection
Patients with gastrointestinal ulcers and incomplete recovery, or patients with acute peptic ulcer
Gastroscopy or imaging examination indicates that the tumor invaded the duodenum or stomach
Patients who have participated in other clinical trials for less than three months
Patients who are judged by researchers as unsuitable for this clinical trial

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Changhai hospital	Shanghai	Shanghai	China	200433

Sponsors and Collaborators

Changhai Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Zhang Huo Jun, Director, Changhai Hospital

ClinicalTrials.gov Identifier:

NCT04699539

Other Study ID Numbers:

Changhai Hospita

First Posted:

Jan 7, 2021

Last Update Posted:

Jul 12, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Zhang Huo Jun, Director, Changhai Hospital

SBRT

Locally Advanced Pancreatic Cancer

Target Delineation

Additional relevant MeSH terms:

Pancreatic Neoplasms

Study Results

No Results Posted as of Jul 12, 2022