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

Phase 2

• Conditions: Pancreatic Neoplasms
• Interventions: Drug: Gemcitabine; Radiation: TS-1 with radiation

• Registration Number: NCT02754180
• Lead Sponsor: Peking Union Medical College Hospital

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.

Study Timeline

• Study Start: 2016-03
• Status Verified: 2016-04
• Study First Submitted: 2016-04-20
• Study First Submitted QC: 2016-04-27
• Last Update Submitted: 2016-04-27
• Study First Posted: 2016-04-28
• Last Update Posted: 2016-04-28
• Primary Completion: 2019-03
• Study Completion: 2021-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 110

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
chemotherapy	Gemcitabine	gemcitabine 1g/m2 iv d1, 8, 15, q4wks. 6 cycles.
chemotherapy with chemoradiation	Gemcitabine	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.
chemotherapy with chemoradiation	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.

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
overall survival	From date of randomization until the date of death from any cause, assessed up to 36 months
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0	from randomization to 1 month after end of treatment

Trial Locations

Locations (1)

Division of Medical Oncology, Peking Union Medical College Hospital; 🇨🇳 Beijing, China