Adjuvant Gemcitabine Versus Gemcitabine With Chemoradiation in Pancreatic Adenocarcinoma With R1 Resection and/or Positive Lymph Nodes

Pancreatic Neoplasms Clinical Trial

Official title:

Adjuvant Gemcitabine Versus Gemcitabine With Chemoradiation in Pancreatic Adenocarcinoma With R1 Resection and/or Positive Lymph Nodes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02754180
• Other study ID #: ZS-1015
• Status: Recruiting
• Phase: Phase 2
• First received: April 20, 2016
• Last updated: April 27, 2016
• Start date: March 2016
• Est. completion date: March 2021

Study information

• Verified date: April 2016
• Source: Peking Union Medical College Hospital
• Contact: Bai Chunmei, MD
• Phone: 861069158773
• Email: baichunmei1964[@]163.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

Adjuvant Gemcitabine Versus Gemcitabine With Chemoradiation in Pancreatic Adenocarcinoma With R1 Resection and/or Positive Lymph Nodes after curative resection.

Description:

Adjuvant Gemcitabine Versus Gemcitabine With TS-1 based Chemoradiation in Pancreatic Adenocarcinoma With R1 Resection and/or Positive Lymph Nodes after curative resection: a randomized phase II study.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: March 2021
• Est. primary completion date: March 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Histologically confirmed resected ductal pancreatic adenocarcinoma with R1 resection and/or positive lymph nodes.

• Subject should start treatment no later than 10 weeks postsurgery.

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

• Acceptable hematology parameters:

• Absolute neutrophil count =1500 cell/mm3

• Platelet count =100,000/mm3

• Hemoglobin (Hgb) =8.0 g/dL

• Acceptable blood chemistry levels:

• Aspartate aminotransferase (AST) and Alanine transaminase (ALT) =2.5 × upper limit of normal range (ULN)

• Total bilirubin = 2.5 x upper Limit of Normal (ULN)

• Serum creatinine within upper limits of normal.

• Cancer antigen (CA)19-9 = 2.5 x upper Limit of Normal (ULN) assessed within 14 days of randomization.

• No disease recurrence or metastases detected on CT/MRI assessed within 30 days of randomization.

• Signed informed consent.

Exclusion Criteria:

• R2 resection or presence of metastatic disease.

• Prior neo-adjuvant treatment or radiation therapy for pancreatic adenocarcinoma.

• Any other malignancy within 5 years prior to randomization, with the exception of adequately treated in-situ carcinoma of the cervix, uteri, bladder, or nonmelanomatous skin cancer.

• Active, uncontrolled infection(s) requiring systemic therapy, defined as ongoing signs/symptoms related to the infection without improvement despite appropriate treatment.

• Severe, active co-morbidity, defined as follows:

• Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months

• Transmural myocardial infarction within the 6 months of study registration

• Uncontrolled hypertension, diabetes or arrhythmia.

• Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization.

• Not able to take medicine orally.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adenocarcinoma
• Pancreatic Neoplasms

Intervention

Drug:
• Gemcitabine
gemcitabine 1g/m2 iv d1, 8, 15, q4wks. 6 cycles

Radiation:
• TS-1 with radiation
gemcitabine 1g/m2 iv d1, 8, 15, q4wks. 6 cycles. Followed by TS-1 based chemoradiation. TS-1 40mg/m2 bid, 5 days/week, with radiation.

Locations

Country	Name	City	State
China	Division of Medical Oncology, Peking Union Medical College Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease free survival		From date of randomization until the date of first documented disease recurrence or date of death from any cause, whichever came first, assessed up to 24 months	No
Secondary	overall survival		From date of randomization until the date of death from any cause, assessed up to 36 months	No
Secondary	Number of participants with treatment-related adverse events as assessed by CTCAE v4.0		from randomization to 1 month after end of treatment	Yes