TAS-102 and Oxaliplatin for the Treatment of Refractory Stage IV Colon Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04294264|
Recruitment Status : Recruiting
First Posted : March 4, 2020
Last Update Posted : September 25, 2020
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Colorectal Carcinoma Recurrent Colon Carcinoma Refractory Colorectal Carcinoma Stage IV Colon Cancer AJCC v7 Stage IVA Colon Cancer AJCC v7 Stage IVB Colon Cancer AJCC v7||Drug: Oxaliplatin Drug: Trifluridine and Tipiracil Hydrochloride||Phase 2|
I. Overall response rate (ORR).
I. Progression free survival (PFS). II. Overall survival (OS). III. Disease control rate (DCR). IV. Duration of response. V. Safety and tolerability.
Patients receive trifluridine and tipiracil hydrochloride (TAS-102) orally (PO) twice daily (BID) on days 1-5 and oxaliplatin intravenously (IV) over 2 hours on day 1. Cycles repeat every 14 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 28 days.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||TAS-102 in Combination With Oxaliplatin (TAS-OX) for Refractory Metastatic Colorectal Cancer|
|Actual Study Start Date :||February 12, 2019|
|Estimated Primary Completion Date :||December 31, 2021|
|Estimated Study Completion Date :||December 31, 2021|
Experimental: Treatment (TAS-102, oxaliplatin)
Patients receive TAS-102 PO BID on days 1-5 and oxaliplatin IV over 2 hours on day 1. Cycles repeat every 14 days in the absence of disease progression or unacceptable toxicity.
Drug: Trifluridine and Tipiracil Hydrochloride
- Overall response rate [ Time Frame: Up to 2 years ]Response rate is defined as the percentage of subjects with a confirmed complete response (CR) or partial response (PR) by investigator assessment as per Response Evaluation Criteria in Solid Tumors (RECIST) criteria, version 1.1. Response rate will be calculated by dose level. Descriptive statistics will be used to analyze efficacy data using historical data as reference.
- Progression free survival [ Time Frame: From the date of start of treatment to the date of first documented progression or any cause of death during the study, assessed up to 2 years ]Progression will be assessed by a computed tomography CT scan according to RECIST criteria version 1.1. This criterion will be estimated by the Kaplan-Meier method. Patients who have not progressed or died at the time of analysis will be censored at the time of their latest follow-up with clinically stable disease.
- Overall survival [ Time Frame: Up to 2 years ]
- Disease control rate [ Time Frame: Up to 2 years ]
- Duration of response [ Time Frame: Up to 2 years ]Response rate will be calculated by dose level. Descriptive statistics will be used to analyze efficacy data using historical data as reference.
- Incidence of adverse events [ Time Frame: Up to 28 days post treatment ]All recorded adverse events will be listed and tabulated by system organ class and dose level. Will utilize the Cancer Therapy Evaluation Program Common Toxicity Criteria (CTC) version 5.0 for toxicity and adverse event reporting.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04294264
|United States, New Jersey|
|Saint Barnabas Medical Center||Recruiting|
|Livingston, New Jersey, United States, 07039|
|Contact: Delia Radovich 973-322-5200 email@example.com|
|Principal Investigator: Delia Radovich|
|Rutgers Cancer Institute of New Jersey||Recruiting|
|New Brunswick, New Jersey, United States, 08903|
|Contact: Howard S. Hochster 732-253-5618 firstname.lastname@example.org|
|Principal Investigator: Howard S. Hochster|
|Principal Investigator:||Howard S Hochster||Rutgers Cancer Institute of New Jersey|