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

NCT02461836 | Unknown Phase 2

• 1 other identifier: YAN2015-030
• Study Type: interventional
• Target: 513
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• disease-free survival (DFS)

  Up to approximately 36 months

Secondary Outcomes (3)

• overall survival (OS)

  Up to approximately 60 months

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

  Up to approximately 60 months

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

  Up to approximately 8 months

Study Arms (2)

Chemo

EXPERIMENTAL

adjuvant chemotherapy using Gemcitabine for 6 rounds

Drug: Gemcitabine

Chemo+SBRT

EXPERIMENTAL

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

Drug: Gemcitabine; Radiation: SBRT

Interventions

Gemcitabine DRUG

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

Also known as: GEM

Chemo; Chemo+SBRT

SBRT RADIATION

Protocol: 5 Gy/d, for 5 consecutive days

Also known as: Radio

Chemo+SBRT

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

the second affiliated hospital of Zhejiang University

Hangzhou, Zhejiang, 310009, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 35941566 DERIVED

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Gemcitabine; Radio

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Audiovisual Aids; Educational Technology; Technology; Technology, Industry, and Agriculture

Study Officials

• Xueli Bai, MD PHD

  Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tingbo Liang, MD PHD

CONTACT

0571-87315006; liangtingbo@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chairman of Department of Hepatobiliary & Pancreatic Surgery, Vice president of the Second Affiliated Hospital, Zhejiang University School of Medicine

Study Record Dates

• First Submitted: May 28, 2015
• First Posted: June 3, 2015
• Study Start: August 1, 2015
• Primary Completion: June 1, 2020
• Study Completion: June 1, 2020
• Last Updated: April 5, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)