search
Back to results

Borderline Resectable Pancreatic Cancer Neoadjuvant Chemoradiotherapy Clinicaltrial-1 (BRPCNCC-1)

Primary Purpose

Pancreatic Cancer

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Neoadjuvant gemcitabine plus nab-paclitaxel
Neoadjuvant gemcitabine plus nab-paclitaxel with SBRT
Neoadjuvant S-1 plus nab-paclitaxel with SBRT
Sponsored by
Changhai Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Cancer focused on measuring pancreatic cancer, neoadjuvant chemotherapy, SBRT

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age≥18 years old and ≤80 years old;
  • Histological proven pancreatic adenocarcinoma;
  • Borderline resectable pancreatic cancer proven by imaging examinations via multidisciplinary approaches according to NCCN guidelines;
  • No prior chemotherapy or radiotherapy;
  • ECOG of 0 or 1;
  • Routine blood test: absolute neutrophil count>1500/mm3, platelet>100000/mm3;
  • Normal liver function: serum total bilirubin≤2.0mg/dl, ALT and AST<2.5 times of the upper limit of normal value;
  • Normal kidney function: serum creatinine<1.5 times of the upper limit of normal value or creatinine clearance rate>45ml/min;
  • No severe comorbidities.

Exclusion Criteria:

  • Metastatic pancreatic cancer;
  • Patients who had surgeries, chemotherapy or other treatments before inclusion;
  • Impaired organ functions: heart failure (New York Heart Association III-IV), coronary heart disease, myocardial infarction within 6 months, severe cardiac arrhythmia and respiratory failure;
  • Confirmed other cancer within 5 years;
  • Pregnant women or lactating women;
  • Patients enrolled in other clinical trials or incompliant of regular follow up;
  • Patients who did not provide an informed consent.

Sites / Locations

  • Changhai HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Group A of neoadjuvant chemotherapy

Group B of neoadjuvant chemoradiotherapy

Group C of neoadjuvant chemoradiotherapy

Arm Description

Neoadjuvant gemcitabine plus nab-paclitaxel is used in this group. Intravenous administration of gemcitabine (1000mg/m2) and nab-paclitaxel (125 mg/m2) are initiated on day 1, 8 and 15 during each 4-week cycle, which will repeat for 3 cycles. And surgical resection is performed after completion of the whole chemotherapy.

Neoadjuvant gemcitabine plus nab-paclitaxel with SBRT is used in this group. Intravenous administration of gemcitabine (1000mg/m2) and nab-paclitaxel (125 mg/m2) are initiated on day 1, 8 and 15 during each 4-week cycle, which will repeat for 3 cycles. After completion of the whole chemotherapy, patients will first receive PET-CT to exclude distant metastases and then undergo SBRT. The prescribed dose is 7.5-8Gy/f for 5 fractions. Dose constraints of normal tissues are referred to the American Association of Physicists in Medicine guidelines in TG-101. And surgical resection is performed 3 weeks after SBRT.

Neoadjuvant S-1 plus nab-paclitaxel with SBRT is used in this group. Intravenous administration of nab-paclitaxel (125 mg/m2) is initiated on day 1, 8 and 15 during each 4-week cycle, which will repeat for 3 cycles. And S-1 is orally administrated at a dose of 80 mg/m2 for 18 days followed by a 10-day rest during each 4-week cycle, which aslo continues for 3 cycles. After completion of the whole chemotherapy, patients will first receive PET-CT to exclude distant metastases and then undergo SBRT. The prescribed dose is 7.5-8Gy/f for 5 fractions. Dose constraints of normal tissues are referred to the American Association of Physicists in Medicine guidelines in TG-101. And surgical resection is performed 3 weeks after SBRT.

Outcomes

Primary Outcome Measures

Overall time
The time between operation and the death of patients

Secondary Outcome Measures

Disease free time
The time between operation and the relapse or metastasis of tumors

Full Information

First Posted
December 14, 2018
Last Updated
August 31, 2023
Sponsor
Changhai Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT03777462
Brief Title
Borderline Resectable Pancreatic Cancer Neoadjuvant Chemoradiotherapy Clinicaltrial-1
Acronym
BRPCNCC-1
Official Title
Comparisons of Different Neoadjuvant Chemotherapy Regimens With or Without Stereotactic Body Radiation Therapy for Borderline Resectable Pancreatic Cancer: Study Protocol of a Prospective, Randomized Phase II Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2019 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Changhai Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study is to investigate whether neoadjuvant chemotherapy plus SBRT results in better outcomes compared with neoadjuvant chemotherapy alone and also compare the efficacy of gemcitabine plus nab-paclitaxel with SBRT and S-1 plus nab-paclitaxel with SBRT.
Detailed Description
This research study is a Phase II clinical trial that investigate whether neoadjuvant chemotherapy plus SBRT results in better outcomes compared with neoadjuvant chemotherapy alone and also compare the efficacy of gemcitabine plus nab-paclitaxel with SBRT and S-1 plus nab-paclitaxel with SBRT. It is known that neoadjuvant therapy is vital for improved survival, which has been confirmed in previous studies that neoadjuvant chemotherapy with or without radiotherapy provides superior overall compared with upfront surgery. However, question of whether the addition of radiotherapy to neoadjuvant chemotherapy can improve prognosis compared with chemotherapy alone is a challenging matter. Also, no studies have evaluated the efficacy of S-1 as the neoadjuvant chemotherapy regimen for BRPC albeit similar prognosis has been found between S-1 and gemcitabine in advanced pancreatic cancer. In this trial, patients with biopsy and radiographically confirmed BRPC will be randomly allocated into three groups: neoadjuvant gemcitabine plus nab-paclitaxel, neoadjuvant gemcitabine plus nab-paclitaxel with SBRT and neoadjuvant S-1 plus nab-paclitaxel with SBRT. Surgical resection will be performed 3 weeks after SBRT. The primary endpoint is overall survival. The secondary outcomes are progression free survival, pathological complete response rate, R0 resection rate and incidence of adverse effects. If results show the survival benefits of neoadjuvant chemotherapy plus SBRT and similar outcomes between S-1 and gemcitabine, it may provide evidence of clinical practice of this modality for BRPC.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
Keywords
pancreatic cancer, neoadjuvant chemotherapy, SBRT

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A of neoadjuvant chemotherapy
Arm Type
Active Comparator
Arm Description
Neoadjuvant gemcitabine plus nab-paclitaxel is used in this group. Intravenous administration of gemcitabine (1000mg/m2) and nab-paclitaxel (125 mg/m2) are initiated on day 1, 8 and 15 during each 4-week cycle, which will repeat for 3 cycles. And surgical resection is performed after completion of the whole chemotherapy.
Arm Title
Group B of neoadjuvant chemoradiotherapy
Arm Type
Experimental
Arm Description
Neoadjuvant gemcitabine plus nab-paclitaxel with SBRT is used in this group. Intravenous administration of gemcitabine (1000mg/m2) and nab-paclitaxel (125 mg/m2) are initiated on day 1, 8 and 15 during each 4-week cycle, which will repeat for 3 cycles. After completion of the whole chemotherapy, patients will first receive PET-CT to exclude distant metastases and then undergo SBRT. The prescribed dose is 7.5-8Gy/f for 5 fractions. Dose constraints of normal tissues are referred to the American Association of Physicists in Medicine guidelines in TG-101. And surgical resection is performed 3 weeks after SBRT.
Arm Title
Group C of neoadjuvant chemoradiotherapy
Arm Type
Experimental
Arm Description
Neoadjuvant S-1 plus nab-paclitaxel with SBRT is used in this group. Intravenous administration of nab-paclitaxel (125 mg/m2) is initiated on day 1, 8 and 15 during each 4-week cycle, which will repeat for 3 cycles. And S-1 is orally administrated at a dose of 80 mg/m2 for 18 days followed by a 10-day rest during each 4-week cycle, which aslo continues for 3 cycles. After completion of the whole chemotherapy, patients will first receive PET-CT to exclude distant metastases and then undergo SBRT. The prescribed dose is 7.5-8Gy/f for 5 fractions. Dose constraints of normal tissues are referred to the American Association of Physicists in Medicine guidelines in TG-101. And surgical resection is performed 3 weeks after SBRT.
Intervention Type
Drug
Intervention Name(s)
Neoadjuvant gemcitabine plus nab-paclitaxel
Intervention Description
Neoadjuvant gemcitabine plus nab-paclitaxel is used in the intervention group for 3 cycles. Standard doses of gemcitabine and nab-paclitaxel are adopted. Surgical resection will be performed after neoadjuvant chemotherapy.
Intervention Type
Drug
Intervention Name(s)
Neoadjuvant gemcitabine plus nab-paclitaxel with SBRT
Intervention Description
Neoadjuvant gemcitabine plus nab-paclitaxel with SBRT is used in the intervention group for 3 cycles. Standard doses of gemcitabine and nab-paclitaxel are adopted. The radiation dose of SBRT is 7.5-8Gy/f for 5 fractions. Surgical resection will be performed 3 weeks after SBRT.
Intervention Type
Drug
Intervention Name(s)
Neoadjuvant S-1 plus nab-paclitaxel with SBRT
Intervention Description
Neoadjuvant S-1 plus nab-paclitaxel with SBRT is used in the intervention group for 3 cycles. Standard doses of gemcitabine and nab-paclitaxel are adopted. The radiation dose of SBRT is 7.5-8Gy/f for 5 fractions. Surgical resection will be performed 3 weeks after SBRT.
Primary Outcome Measure Information:
Title
Overall time
Description
The time between operation and the death of patients
Time Frame
From date of randomization until the date of death from any cause, whichever came first, assessed up to 24 months
Secondary Outcome Measure Information:
Title
Disease free time
Description
The time between operation and the relapse or metastasis of tumors
Time Frame
From date of randomization until the date of first documented progression or metastasis, assessed up to 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age≥18 years old and ≤80 years old; Histological proven pancreatic adenocarcinoma; Borderline resectable pancreatic cancer proven by imaging examinations via multidisciplinary approaches according to NCCN guidelines; No prior chemotherapy or radiotherapy; ECOG of 0 or 1; Routine blood test: absolute neutrophil count>1500/mm3, platelet>100000/mm3; Normal liver function: serum total bilirubin≤2.0mg/dl, ALT and AST<2.5 times of the upper limit of normal value; Normal kidney function: serum creatinine<1.5 times of the upper limit of normal value or creatinine clearance rate>45ml/min; No severe comorbidities. Exclusion Criteria: Metastatic pancreatic cancer; Patients who had surgeries, chemotherapy or other treatments before inclusion; Impaired organ functions: heart failure (New York Heart Association III-IV), coronary heart disease, myocardial infarction within 6 months, severe cardiac arrhythmia and respiratory failure; Confirmed other cancer within 5 years; Pregnant women or lactating women; Patients enrolled in other clinical trials or incompliant of regular follow up; Patients who did not provide an informed consent.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shiwei Guo, Doctor
Phone
+8618621500666
Email
gestwa@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Suizhi Gao, Master
Phone
+8613167137990
Email
gaosuizhi@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gang Jin, Doctor
Organizational Affiliation
Changhai Hospital, Shanghai, China
Official's Role
Principal Investigator
Facility Information:
Facility Name
Changhai Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200433
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shiwei Guo, Doctor
Phone
+8618621500666
Email
gestwa@163.com
First Name & Middle Initial & Last Name & Degree
Suizhi Gao, Master
Phone
+8613167137990
Email
gaosuizhi@163.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
30917842
Citation
Gao S, Zhu X, Shi X, Cao K, Bian Y, Jiang H, Wang K, Guo S, Zhang H, Jin G. Comparisons of different neoadjuvant chemotherapy regimens with or without stereotactic body radiation therapy for borderline resectable pancreatic cancer: study protocol of a prospective, randomized phase II trial (BRPCNCC-1). Radiat Oncol. 2019 Mar 27;14(1):52. doi: 10.1186/s13014-019-1254-8.
Results Reference
derived

Learn more about this trial

Borderline Resectable Pancreatic Cancer Neoadjuvant Chemoradiotherapy Clinicaltrial-1

We'll reach out to this number within 24 hrs