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Completed

NCT Number: NCT02558868

Second-Line Oxaliplatin and Irinotecan Versus Irinotecan Alone for Gemcitabine and S-1 Refractory Pancreatic Cancer

This study is a randomized, open-label, controlled study that will compare the efficacy of oxaliplatin in combination with irinotecan to irinotecan alone as second-line treatment for patients with gemcitabine and S-1 refractory pancreatic cancer.

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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

First affiliated hospital, Zhejiang University

Hangzhou, Zhejiang, 310006, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with histologically confirmed advanced pancreatic cancer who had experienced progression during first-line gemcitabine and S-1 were eligible for enrollment on this open-label, randomized study.
  • Additional inclusion criteria were age 18 years or older
  • Measurable reference cancer site(s) confirmed with computed tomography (CT) or magnetic resonance imaging (MRI)
  • Karnofsky performance status (KPS) of at least 70%
  • -Adequate renal function, adequate hepatic function, adequate bone marrow function

Exclusion criteria

  • The presence of any severe concomitant disease that could interrupt the planned treatment; intractable pain
  • Hypersensitivity to study drugs
  • Serious cardiovascular disease (eg, unstable coronary artery disease or myocardial infarction within 4 weeks of study start)
  • National Cancer Institute CommonToxicity Criteria grade 3 or 4 sensory or motor neuropathy
  • Prior or concurrent malignancy (other than pancreatic cancer)
  • Female, pregnancy or breastfeeding.

Treatment and study plan

Irinotecan

Drug

Oxaliplatin

Drug

Primary outcomes

  1. Overall Survival

    Time frame: 1 years

Secondary outcomes

  1. Progression Free Survival

    Time frame: 1 years

Sponsors and collaborators

Lead sponsor

Zhejiang University

Other

Registry information

Official study title

Second-Line Oxaliplatin and Irinotecan Versus Irinotecan Alone for Advanced Pancreatic Cancer Patients Progressed After First-line Gemcitabine and S-1: A Randomized Controlled Study

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Sep 24, 2015
Registry last updated
Jun 21, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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