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

NCT04699539 | Completed Results

• 1 other identifier: Changhai Hospita
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare the efficacy and safety of a recurrence-pattern-based-volume versus conventional-volume stereotactic body radiation therapy for locally advanced pancreatic cancer, so as to determine whether the target delineation method based on recurrence pattern can obtain better survival benefits.

Conditions

Treatment

Keywords

SBRT; Locally Advanced Pancreatic Cancer; Target Delineation

Outcome Measures

Primary Outcomes (1)

• 1-year Progression Free Survival Rate

  The proportion of patients without disease progression at one year

  1 year

Secondary Outcomes (3)

• Treatment-related Adverse Events

  4 years

• Progression Free Survival

  4 years

• Overall Survival

  4 years

Study Arms (2)

Arm A

ACTIVE COMPARATOR

A conventional-volume stereotactic body radiation therapy following gemcitabine and nab-paclitaxel

Radiation: SBRT; Drug: Chemotherapy

Arm B

EXPERIMENTAL

A recurrence-pattern-based-volume stereotactic body radiation therapy following gemcitabine and nab-paclitaxel

Radiation: SBRT; Drug: Chemotherapy

Interventions

SBRT RADIATION

A conventional-volume stereotactic body radiation therapy: planning target volume should include gross tumor volume with a uniform 3mm margin in all directions. A recurrence-pattern-based volume stereotactic body radiation therapy: planning target volume should include gross tumor volume with a 3mm margin in the anterior and lateral directions, 10mm margin in the cranial and caudal directions that should cover the full circumstance of celiac artery and superior mesenteric artery, 15mm in the posterior direction that should cover the retroperitoneal space. The prescribed dose of PTV varies from 30-50Gy/5-6f.

Arm A; Arm B

Chemotherapy DRUG

Gemcitabine (1000mg/m2，d1, 8) + albumin-bound paclitaxel (125mg/m2，d1, 8) , repeat every 3 weeks for 6 cycles

Arm A; Arm B

Eligibility Criteria

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

You may qualify if:

• Cytologically or histologically verified pancreatic adenocarcinoma
• Imaging examinations confirmed locally advanced pancreatic cancer
• No previous radiotherapy, chemotherapy, immunotherapy or targeted therapy
• ECOG of 0 to1
• Age of 18 years or older
• Adequate bone marrow function, defined as: 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
• Adequate liver and renal, defined as: 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)
• Adequate blood clotting function, defined as: international normalized ratio (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:

• Previously receiving radiotherapy, chemotherapy, immunotherapy or targeted therapy
• Evidences of metastatic disease confirmed by chest CT or PET-CT
• ECOG ≥2
• Age \<18 years
• Secondary malignancy
• Abnormal results of blood routine examinations and liver and kidney and coagulation tests
• Patients with active inflammatory bowel diseases or peptic ulcer
• Gastrointestinal bleeding or perforation within 6 months
• Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals
• Medical history of symptomatic congestive heart failure: New York Heart Association Class III to IV
• Medical history of respiratory insufficiency
• Women who are pregnant or breastfeeding
• Participation in another clinical treatment trial
• 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

MeSH Terms

Interventions

Drug Therapy

Intervention Hierarchy (Ancestors)

Therapeutics

Results Point of Contact

• Title: Xiaofei Zhu
• Organization: Changhai Hos

zhuxiaofei_zxf@163.com

86-021-31162222

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: November 9, 2020
• First Posted: January 7, 2021
• Study Start: December 1, 2020
• Primary Completion: August 16, 2025
• Study Completion: August 16, 2025
• Last Updated: December 10, 2025
• Results First Posted: December 10, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)