Clinical trial NCT02754180: Adjuvant Gemcitabine Versus Gemcitabine With Chemoradiation in Pancreatic Adenocarcinoma With R1 Resection and/or Positive Lymph Nodes
Official title: Adjuvant Gemcitabine Versus Gemcitabine With Chemoradiation in Pancreatic Adenocarcinoma With R1 Resection and/or Positive Lymph Nodes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Pancreatic Neoplasms
Keywords: adjuvant
pancreatic cancer
R1 resection
positive lymph nodes
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2016-04-28
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Disease free survival
timeFrame: 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
Secondary outcomes:
measure: overall survival
timeFrame: From date of randomization until the date of death from any cause, assessed up to 36 months
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
timeFrame: from randomization to 1 month after end of treatment
Other outcomes:
Locations:
city: Beijing
country: China
facility: Division of Medical Oncology, Peking Union Medical College Hospital
Study officials:
References: