Stereotactic Radiotherapy in Locally Advanced Pancreatic Cancer With Different Biological Effective Doses

Not Applicable

• Conditions: Treatment
• Interventions: Radiation: SBRT; Drug: Chemotherapy

• Registration Number: NCT04603586
• Lead Sponsor: Changhai Hospital

Brief Summary

The aim of this study is to compare the safety and efficacy of SBRT in LAPC with different biological effective dose (BED) (60-70Gy Vs.\>70Gy ) , to identify a dose range that could achieve better survival benefit and minimize the toxicity of radiotherapy.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-10
• Study First Submitted: 2020-10-15
• Study Start: 2020-10-20
• Study First Submitted QC: 2020-10-20
• Study First Posted: 2020-10-27
• Last Update Submitted: 2020-10-27
• Last Update Posted: 2020-10-29
• Primary Completion: 2022-10-01
• Study Completion: 2023-10-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 138

Inclusion Criteria

• 18≤Age≤75 years
• Cytologically or histologically verified pancreatic adenocarcinoma or clinically diagnosed as pancreatic cancer by multidisciplinary consultation
• locally advanced pancreatic cancer (LAPC)
• SBRT was not preceded by any targeted antitumor therapy
• ECOG 0-1
• Written informed consent according to ICH/GCP regulations before registration and prior to any trial specific procedures

Exclusion Criteria

• Patients who have previously received related treatment because of pancreatic adenocarcinoma, such as radiotherapy, chemotherapy or focal treatment
• Patients with severe liver or kidney dysfunction
• Patients with obstructive jaundice
• Patients with mass ascites
• Patients participated in other clinical trials for less than three months
• Patients with other malignancies, or acute or other severe infections, with ulcerative colitis, inflammatory bowel disease, ect
• Unsuitable to participate in this clinical trial judged by the investigator

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm A	Chemotherapy	SBRT with BED 60-70Gy combined with Gemcitabine + albumin-bound paclitaxel
Arm A	SBRT	SBRT with BED 60-70Gy combined with Gemcitabine + albumin-bound paclitaxel
Arm B	SBRT	SBRT with BED \>70Gy combined with Gemcitabine + albumin-bound paclitaxel
Arm B	Chemotherapy	SBRT with BED \>70Gy combined with Gemcitabine + albumin-bound paclitaxel

Primary Outcome Measures

Name	Time	Method
1-year Disease Progression-Free-Survival (DPFS)	1-year	Disease Progression-Free-Survival (DPFS)

Secondary Outcome Measures

Name	Time	Method
The Probability of gastrointestinal (GI) Toxicity	1-year	gastrointestinal (GI) toxicity
1-year Local Control Rate	1-year	Local Control Rate
Overall Survival	1-year	Overall Survival

Trial Locations

Locations (2)

Changhai hospital; 🇨🇳 Shanghai, Shanghai, China

Shanghai Changhai Hospital; 🇨🇳 Shanghai, Shanghai, China