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

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase: Unknown; Phase 2

Conditions: Pancreatic Neoplasms

Treatments: Radiation: TS-1 with radiation; Drug: Gemcitabine

Study type: Interventional

Funder types: Other

Identifiers

NCT02754180

ZS-1015

Details and patient eligibility

About

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

Full 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.

Enrollment: 110 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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110 participants in 2 patient groups

chemotherapy

Active Comparator group

Description:

gemcitabine 1g/m2 iv d1, 8, 15, q4wks. 6 cycles.

Treatment:

Drug: Gemcitabine

chemotherapy with chemoradiation

Experimental group

Description:

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.

Treatment:

Radiation: TS-1 with radiation

Drug: Gemcitabine