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

Treatment Clinical Trial

Official title:

A Prospective Phase Ⅱ Clinical Study of Stereotactic Radiotherapy Combined With Chemotherapy With Different Biological Effective Doses (60-70gy vs. >70Gy) in Locally Advanced Pancreatic Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04603586
• Other study ID #: Changhai Hospit
• Status: Recruiting
• Phase: N/A
• Start date: October 20, 2020
• Est. completion date: October 1, 2023

Study information

• Verified date: October 2020
• Source: Changhai Hospital
• Contact: Huojun Zhang, M.D.
• Phone: 021-31162222
• Email: chyyzhj[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 138
• Est. completion date: October 1, 2023
• Est. primary completion date: October 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Pancreatic Neoplasms
• Treatment

Intervention

Radiation:
• SBRT
SBRT: in 5-6 fractions with CyberKnife

Drug:
• Chemotherapy
1000 mg of Gemcitabine + albumin-bound paclitaxel per square meter of body surface area on days 1, 8 for 2 weeks, followed by 1 weeks of rest as one course

Locations

Country	Name	City	State
China	Changhai hospital	Shanghai	Shanghai
China	Shanghai Changhai Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Changhai Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	1-year Disease Progression-Free-Survival (DPFS)	Disease Progression-Free-Survival (DPFS)	1-year
Secondary	The Probability of gastrointestinal (GI) Toxicity	gastrointestinal (GI) toxicity	1-year
Secondary	1-year Local Control Rate	Local Control Rate	1-year
Secondary	Overall Survival	Overall Survival	1-year