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A Real-World Study to Learn More About the Order of Different Treatments and Their Effects in People With Metastatic Colorectal Cancer Receiving Their Third and Fourth Line of Treatment - Trial NCT06137170

Access comprehensive clinical trial information for NCT06137170 through Pure Global AI's free database. This phase not specified trial is sponsored by Bayer and is currently Not yet recruiting. The study focuses on Metastatic Colorectal Cancer. Target enrollment is 200 participants.

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NCT06137170
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Trial Details
ClinicalTrials.gov โ€ข NCT06137170
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A Real-World Study to Learn More About the Order of Different Treatments and Their Effects in People With Metastatic Colorectal Cancer Receiving Their Third and Fourth Line of Treatment
Real-world Sequence of Systemic Therapies and Outcomes in Patients With Metastatic Colorectal Cancer Receiving 3rd and 4th Line of Treatment.

Study Focus

Regorafenib (Stivarga, BAY73-4506)

Observational

drug

Sponsor & Location

Bayer

Timeline & Enrollment

N/A

Nov 15, 2023

Dec 15, 2023

200 participants

Primary Outcome

Duration of sequential treatment (DoT),Proportion of patients receiving subsequent therapies following sequential treatment during all available follow up after end of sequential treatment,Number and type of subsequent therapies,Proportion of patients using myelopoiesis supporting therapy,Overall Survival (OS)

Summary

This is an observational study in which data already collected from people with metastatic
 colorectal cancer will be studied.
 
 Metastatic colorectal cancer (mCRC) is a cancer of the colon (large bowel) or the rectum
 (lowest part of the bowel just before the anus). Cancer is considered metastatic if it
 spreads to other parts of the body.
 
 The study drug, regorafenib, is already approved for doctors to prescribe to people with
 mCRC. It is an anti-cancer drug that blocks several proteins, called enzymes, which are
 involved in the growth of cancer. Other approved treatments for mCRC include TAS and
 bevacizumab. The combination of the anti-cancer drugs trifluridine and tipiracil is called
 TAS. Both TAS and bevacizumab prevent cancer cells from growing and multiplying.
 
 Some studies have shown that people with mCRC who took TAS along with bevacizumab, lived
 longer than when TAS was taken alone. This may be especially beneficial for patients who have
 tried other treatments before. However, there is limited knowledge about how and in which
 order these drugs are given.
 
 To better understand the impact of the order of taking regorafenib and TAS, with or without
 bevacizumab, more knowledge is needed about how well these treatments work in people with
 mCRC in European countries.
 
 The main purpose of this study is to learn more about the effects of treatment in people with
 mCRC who have already received regorafenib and TAS, with or without bevacizumab, one after
 the other (also called sequential treatment) in a different order.
 
 To do this, researchers will collect the following information:
 
 - how long participants received sequential treatment for mCRC
 
 - number of participants receiving further treatment for mCRC after the sequential
 treatment
 
 - number and type of further treatments for mCRC
 
 - how long did participants live (also called overall survival).
 
 The data will come from the participants' information stored in health records from 4 centers
 in 3 European countries including France, Italy, and Spain. The data will be from people with
 mCRC who started sequential treatment between January 2013 and December 2022 or until the
 most recent date that allows researchers to assess the participants' health for at least 3
 months.
 
 In this study, only available data from routine care are collected. No visits or tests will
 be required as part of this study.

ICD-10 Classifications

Malignant neoplasm of colon
Malignant neoplasm: Colon, unspecified
Malignant neoplasm: Descending colon
Malignant neoplasm: Ascending colon
Malignant neoplasm: Overlapping lesion of colon

Data Source

ClinicalTrials.gov

NCT06137170

Non-Device Trial