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Study of Stereotactic Body Radiation Therapy for Patients After Radical Resection of Pancreatic Cancer With Advanced Stages (T3 or N1)

Primary Purpose

Pancreatic Cancer

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Gemcitabine

SBRT

About this trial

This is an interventional treatment trial for Pancreatic Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Male/Female subjects, age ≥ 18 years and ≤ 75 years old at the time informed consent is signed
Pathologically confirmed pancreatic adenocarcinoma or mixed-type pancreatic carcinoma (adenocarcinoma predominantly)
The operation must be radical resection (R0), with all margins negative.
Eastern Cooperative Oncology Group (ECOG) score: 0-2
Without large volume ascites or pleural effusion
Lab tests:
a Complete blood cell count: HGB≥100g/L, WBC≥4×109/L, PLT≥100×109/L b Liver function: Total bilirubin≤3 x upper limit of normal range (ULN) with direct bilirubin within normal range, alanine aminotransferase (ALT) / aspartate aminotransferase (AST)≤3 c Renal function: Creatine≤1.5 x ULN or creatine clearance≥60 ml/min
Heart and lung function well (Eject function>55%)
Females of child-bearing potential must demonstrate a negative serum pregnancy test result at screening confirmed by local negative urine pregnancy dipstick within 72 hours prior to the first dose of Gemcitabine.
At least 30 days from major surgery before randomization, with full recovery
Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures are conducted
Able to adhere to the study visit schedule and other protocol requirements

Exclusion Criteria:

Margin positive resections (R1 or R2)
Resection of recurrence pancreatic cancer
Other types of pancreatic cancer (non-adenocarcinoma)
Subjects with severe complications, can't tolerate chemotherapy in 4-12 weeks after surgery
Subjects with severe bone marrow suppression
Subjects with a history of severe lung diseases (interstitial lung disease, sarcoidosis, silicosis, idiopathic pulmonary fibrosis, pulmonary hypersensitivity pneumonitis), severe liver diseases (active hepatitis, liver cirrhosis), renal dysfunction, uncontrolled diabetes and hypertension, or multiple and severe allergies which may lead to serious complications
Subjects with severe heart diseases (congested heart failure, systematic coronary disease, uncontrolled arrhythmia, or myocardial infarction in 6 months)
Under treatment with steroids for a long time
Subjects with early recurrence of pancreatic cancer before initiation of chemotherapy
Subjects with diarrhea and infection (body temperature >38.5℃)
Subjects who was enrolled into another clinical study or finished another clinical study within the previous 4 weeks prior to randomization
Pregnant or nursing women
Subjects with other type of malignancies, except of curated basal cell carcinoma and carcinoma in situ of cervix which finished treatments more than half one year ago
Subjects having any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent them from participating in the study
Any condition that confounds interpreting data from the study

Sites / Locations

the second affiliated hospital of Zhejiang UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Chemo

Chemo+SBRT

Arm Description

adjuvant chemotherapy using Gemcitabine for 6 rounds

SBRT is delivered prior to adjuvant chemotherapy with Gemcitabine for 6 rounds

Outcomes

Primary Outcome Measures

disease-free survival (DFS)

Secondary Outcome Measures

overall survival (OS)

quality of life (QOL) as assessed by the EORTC (European Organisation for Research and Treatment of Cancer) QLQ-PAN26 score

safety as assessed according to NCI-CTCAE (Common Toxicity Criteria for Adverse Effects) Ver. 4

according to NCI-CTCAE (Common Toxicity Criteria for Adverse Effects) Ver. 4

Full Information

NCT ID

NCT02461836

First Posted

May 28, 2015

Last Updated

April 4, 2017

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

1. Study Identification

Unique Protocol Identification Number

NCT02461836

Brief Title

Study of Stereotactic Body Radiation Therapy for Patients After Radical Resection of Pancreatic Cancer With Advanced Stages (T3 or N1)

Official Title

An Open-Labeled, Randomized Phase II Trial of Adjuvant Chemotherapy in Combination With Stereotactic Body Radiation Therapy (SBRT) Versus Adjuvant Chemotherapy Alone for Patients After Radical Resection of Pancreatic Cancer With Advanced Stages (T3 or N1)

Study Type

Interventional

2. Study Status

Record Verification Date

April 2017

Overall Recruitment Status

Unknown status

Study Start Date

August 2015 (undefined)

Primary Completion Date

June 2020 (Anticipated)

Study Completion Date

June 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Pancreatic cancer is one of the deadliest tumor types of the alimentary system. Resection is the only curable method to treat pancreatic cancer. However, even if radical resection is achieved, the 5-year survival rate is still low because of tumor recurrence. It's reported adjuvant radiation can prolong survival and improve quality of life after surgery. For R0 (microscopic negative margin) resection patients with advanced stages (T3 or N1), the value of adjuvant radiation is still in debate. It's warranted to explore the role of adjuvant radiation for patients after radical resection of pancreatic cancer with advanced stages (T3 or N1) in large, prospective, and randomized cohorts. The application of Stereotactic Body Radiation Therapy (SBRT) makes radiation less harmful and more flexible. It is hoped that adjuvant SBRT may benefit post-operative patients with advanced stages and one day adjuvant SBRT combined with chemotherapy become the standard of care for pancreatic cancer patients.

Detailed Description

Pancreatic cancer is one of the deadliest tumor types of the alimentary system. Despite of the dramatic progress of diagnostic methods and surgical technics, the overall 5-year survival is still around 5%. Resection is the only curable method to treat pancreatic cancer, although only a small proportion of patients are eligible for operation. However, even if radical resection is achieved, the 5-year survival rate is only 15-20%. The main cause of death is tumor recurrence, which is as high as 50-70% in 3 years after operation. By now, it is widely accepted that pancreatic cancer is a systemic disease. Systemic treatments are recommended in neoadjuvant and adjuvant manners. It's reported adjuvant radiation can prolong survival and improve quality of life after surgery, especially for patients who undergo a R1 (microscopic positive margin) and R2 (macroscopic positive margin) resection. For R0 (microscopic negative margin) resection patients with advanced stages (T3 or N1), the value of adjuvant radiation is still in debate. Some argues adjuvant radiation after radical resection makes no effect on preventing local recurrence and metastasis but may impair patients' quality of life and overall survival. On the contrary, some other researchers draw the conclusion that adjuvant radiation may facilitate the local control of tumor recurrence in small cohorts. It's warranted to explore the role of adjuvant radiation for patients after radical resection of pancreatic cancer with advanced stages (T3 or N1) in large, prospective, and randomized cohorts. Traditionally, radiation may take more than one month to deliver and the dosage is restricted to prevent damage to surrounding tissues. The size effects and duration impair patients' compliance. Recently, the application of Stereotactic Body Radiation Therapy (SBRT) makes radiation less harmful and more flexible. The advantages of SBRT are higher dosage of radiation, less damage to surrounding organs, and significant reduce of duration. To our knowledge, there is no big randomized clinical trial to evaluate the value of SBRT for patients after radical resection of pancreatic cancer with advanced stages (T3 or N1). It is hoped that adjuvant SBRT may benefit post-operative patients with advanced stages and one day adjuvant SBRT combined with chemotherapy become the standard of care for pancreatic cancer patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pancreatic Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

513 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Chemo

Arm Type

Experimental

Arm Description

adjuvant chemotherapy using Gemcitabine for 6 rounds

Arm Title

Chemo+SBRT

Arm Type

Experimental

Arm Description

SBRT is delivered prior to adjuvant chemotherapy with Gemcitabine for 6 rounds

Intervention Type

Drug

Intervention Name(s)

Gemcitabine

Other Intervention Name(s)

GEM

Intervention Description

Protocol: Gemcitabine 1000mg/m2.body surface area (BSA), IV infusion for at least 30 mins, administered at Day1, Day8, Day15)

Intervention Type

Radiation

Intervention Name(s)

SBRT

Other Intervention Name(s)

Radio

Intervention Description

Protocol: 5 Gy/d, for 5 consecutive days

Primary Outcome Measure Information:

Title

disease-free survival (DFS)

Time Frame

Up to approximately 36 months

Secondary Outcome Measure Information:

Title

overall survival (OS)

Time Frame

Up to approximately 60 months

Title

quality of life (QOL) as assessed by the EORTC (European Organisation for Research and Treatment of Cancer) QLQ-PAN26 score

Time Frame

Up to approximately 60 months

Title

safety as assessed according to NCI-CTCAE (Common Toxicity Criteria for Adverse Effects) Ver. 4

Description

according to NCI-CTCAE (Common Toxicity Criteria for Adverse Effects) Ver. 4

Time Frame

Up to approximately 8 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male/Female subjects, age ≥ 18 years and ≤ 75 years old at the time informed consent is signed Pathologically confirmed pancreatic adenocarcinoma or mixed-type pancreatic carcinoma (adenocarcinoma predominantly) The operation must be radical resection (R0), with all margins negative. Eastern Cooperative Oncology Group (ECOG) score: 0-2 Without large volume ascites or pleural effusion Lab tests: a Complete blood cell count: HGB≥100g/L, WBC≥4×109/L, PLT≥100×109/L b Liver function: Total bilirubin≤3 x upper limit of normal range (ULN) with direct bilirubin within normal range, alanine aminotransferase (ALT) / aspartate aminotransferase (AST)≤3 c Renal function: Creatine≤1.5 x ULN or creatine clearance≥60 ml/min Heart and lung function well (Eject function>55%) Females of child-bearing potential must demonstrate a negative serum pregnancy test result at screening confirmed by local negative urine pregnancy dipstick within 72 hours prior to the first dose of Gemcitabine. At least 30 days from major surgery before randomization, with full recovery Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures are conducted Able to adhere to the study visit schedule and other protocol requirements Exclusion Criteria: Margin positive resections (R1 or R2) Resection of recurrence pancreatic cancer Other types of pancreatic cancer (non-adenocarcinoma) Subjects with severe complications, can't tolerate chemotherapy in 4-12 weeks after surgery Subjects with severe bone marrow suppression Subjects with a history of severe lung diseases (interstitial lung disease, sarcoidosis, silicosis, idiopathic pulmonary fibrosis, pulmonary hypersensitivity pneumonitis), severe liver diseases (active hepatitis, liver cirrhosis), renal dysfunction, uncontrolled diabetes and hypertension, or multiple and severe allergies which may lead to serious complications Subjects with severe heart diseases (congested heart failure, systematic coronary disease, uncontrolled arrhythmia, or myocardial infarction in 6 months) Under treatment with steroids for a long time Subjects with early recurrence of pancreatic cancer before initiation of chemotherapy Subjects with diarrhea and infection (body temperature >38.5℃) Subjects who was enrolled into another clinical study or finished another clinical study within the previous 4 weeks prior to randomization Pregnant or nursing women Subjects with other type of malignancies, except of curated basal cell carcinoma and carcinoma in situ of cervix which finished treatments more than half one year ago Subjects having any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent them from participating in the study Any condition that confounds interpreting data from the study

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Tingbo Liang, MD PHD

Phone

0571-87315006

liangtingbo@zju.edu.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Xueli Bai, MD PHD

Organizational Affiliation

Zhejiang University

Official's Role

Principal Investigator

Facility Information:

Facility Name

the second affiliated hospital of Zhejiang University

City

Hangzhou

State/Province

Zhejiang

ZIP/Postal Code

310009

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Tao Ma, MD,PhD

Phone

+8613857148997

zjumatao@gmail.com

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

35941566

Citation

Ma T, Bai X, Wei Q, Shui Y, Lao M, Chen W, Huang B, Que R, Gao S, Zhang Y, Chen W, Wang J, Liang T. Adjuvant therapy with gemcitabine and stereotactic body radiation therapy versus gemcitabine alone for resected stage II pancreatic cancer: a prospective, randomized, open-label, single center trial. BMC Cancer. 2022 Aug 8;22(1):865. doi: 10.1186/s12885-022-09974-7.

Results Reference

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Study of Stereotactic Body Radiation Therapy for Patients After Radical Resection of Pancreatic Cancer With Advanced Stages (T3 or N1)

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