Neoplasms

All Conditions

Digestive System Diseases

Gland and Hormone Related Diseases

Rare Diseases

Adenocarcinoma

Pancreatic Neoplasms

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Single group assignment of TAS-102 in Patients with Advanced, Refractory Pancreatic Adenocarcinoma

Days 1 through 5: TAS-102 (35 mg/m2/dose) orally 2 times daily with the first dose administered in the morning of Day 1 of each cycle and the last dose administered in the evening of Day 5.

Days 6 through 7: Recovery Days 8 through 12: TAS-102 (35 mg/m2/dose) orally 2 times daily with the first dose administered in the morning of Day 8 of each cycle and the last dose administered in the evening of Day 12.

Days 13 through 28: Recovery

TAS 102

Chi Leung Chiang, FRCR

This study is a prospective phase II, single arm mono-institutional study conducted in Queen Mary Hospital (Hong Kong) assessing the efficacy and safety of TAS 102 in advanced or metastatic pancreatic cancer patients.

All the patients must be registered with the Investigator(s) prior to initiation of treatment. The registration desk will confirm all eligibility criteria and obtain essential information (including patient number).

TAS-102 in Patients With Advanced, Refractory Pancreatic Adenocarcinoma

Phase II Trial of TAS-102 in Patients With Advanced, Refractory Pancreatic Adenocarcinoma

The percentage of study population alive and without progression (according to RECIST 1.1) at 16 weeks from the date of informed consent

PFS is measured from the date of informed consent to radiographically documented progression according to RECIST 1.1 or death from any cause (whichever occurs first). Participants alive and without disease progression or lost to follow up will be censored at the date of their last radiographic assessment.

TTP is measured from the date of informed consent to radiographically documented progression according to RECIST 1.1. Participants death and without disease progression, alive without disease progression, or lost to follow-up will be censored at the date of their last radiographic assessment

OS is measured from date of informed consent to the date of death from any cause. Participants alive or lost to follow-up will be censored at the date of their last radiographic assessment

The percentage of patients with radiologically complete or partial response as determined by the Investigator according to RECIST version 1.1.

The percentage of patients with radiologically complete response, partial response, or stable disease as determined by the Investigators according to RECIST version 1.1

DoR is the time from documentation of tumor response to radiographically documented disease progression

Time from date of informed consent until the first date on which ECOG performance status score of 2 or higher was recorded

Decrease from baseline of 10 points or more on the EORTC QLQ-C30 maintained for two consecutive assessments or a decrease of 10 points or more in one assessment followed by death from any cause within 3 weeks

Incidence, nature, and severity of adverse events graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE 5)

Spots Global Cancer Trial Database for TAS-102 in Patients With Advanced, Refractory Pancreatic Adenocarcinoma

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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