Metastatic Colorectal Cancer Clinical Trial
— RegoSeqOfficial title:
Real-world Sequence of Systemic Therapies and Outcomes in Patients With Metastatic Colorectal Cancer Receiving 3rd and 4th Line of Treatment.
Verified date | June 2024 |
Source | Bayer |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Active, not recruiting |
Enrollment | 200 |
Est. completion date | November 29, 2024 |
Est. primary completion date | November 29, 2024 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Aged =18 years at diagnosis of mCRC - Histologically confirmed diagnosis of mCRC - Received sequential treatment with regorafenib followed by TAS with or without Bevacizumab (R-TAS±BEV, without other therapies in-between) and vice versa (TAS±BEV -R without other therapies in-between) from January 1, 2013 to December 31, 2022 (inclusion period), or the latest available date that allows at least 3 months of follow-up - Have at least 6 months of available data before index date (baseline period) and at least 3 months of follow-up data Exclusion Criteria: - Patients who had a diagnosis of any other primary cancer (including gastrointestinal stromal tumors (GIST) and hepatocellular carcinoma (HCC)) except non-melanoma skin cancers during baseline - Patients involved in clinical trials during the study period |
Country | Name | City | State |
---|---|---|---|
France | Many Locations | Multiple Locations | |
Italy | Many Locations | Multiple Locations | |
Spain | Many Locations | Multiple Locations |
Lead Sponsor | Collaborator |
---|---|
Bayer |
France, Italy, Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Duration of sequential treatment (DoT) | Retrospective analysis between January 1, 2013 and December 31, 2022 or the latest available date that allows at least 3 months follow-up | ||
Primary | Proportion of patients receiving subsequent therapies following sequential treatment during all available follow up after end of sequential treatment | Retrospective analysis between January 1, 2013 and December 31, 2022 or the latest available date that allows at least 3 months follow-up | ||
Primary | Number and type of subsequent therapies | Retrospective analysis between January 1, 2013 and December 31, 2022 or the latest available date that allows at least 3 months follow-up | ||
Primary | Proportion of patients using myelopoiesis supporting therapy | Retrospective analysis between January 1, 2013 and December 31, 2022 or the latest available date that allows at least 3 months follow-up | ||
Primary | Overall Survival (OS) | Retrospective analysis between January 1, 2013 and December 31, 2022 or the latest available date that allows at least 3 months follow-up | ||
Secondary | Descriptive analysis of demographic characteristics | Retrospective analysis between January 1, 2013 and December 31, 2022 or the latest available date that allows at least 3 months follow-up | ||
Secondary | ECOG at index (the closest measurement before index date) | Descriptive analysis of clinical characteristics: Descriptive statistics will be calculated. Categorical variables will be summarized using frequency (number of patients [N]) and percentage (%) of total study persons observed in each group. Continuous and count variables will be presented as the mean, standard deviation (SD) and median. As relevant, continuous variables will also be categorized into intervals. | Retrospective analysis between January 1, 2013 and December 31, 2022 or the latest available date that allows at least 3 months follow-up | |
Secondary | Location of primary cancer: left colon, right colon, rectum | Descriptive analysis of clinical characteristics: Descriptive statistics will be calculated. Categorical variables will be summarized using frequency (number of patients [N]) and percentage (%) of total study persons observed in each group. Continuous and count variables will be presented as the mean, standard deviation (SD) and median. As relevant, continuous variables will also be categorized into intervals. | Retrospective analysis between January 1, 2013 and December 31, 2022 or the latest available date that allows at least 3 months follow-up | |
Secondary | TNM stage at diagnosis | Descriptive analysis of clinical characteristics: Descriptive statistics will be calculated. Categorical variables will be summarized using frequency (number of patients [N]) and percentage (%) of total study persons observed in each group. Continuous and count variables will be presented as the mean, standard deviation (SD) and median. As relevant, continuous variables will also be categorized into intervals. | Retrospective analysis between January 1, 2013 and December 31, 2022 or the latest available date that allows at least 3 months follow-up | |
Secondary | Metastasis location: lung, hepatic, other sites | Descriptive analysis of clinical characteristics: Descriptive statistics will be calculated. Categorical variables will be summarized using frequency (number of patients [N]) and percentage (%) of total study persons observed in each group. Continuous and count variables will be presented as the mean, standard deviation (SD) and median. As relevant, continuous variables will also be categorized into intervals. | Retrospective analysis between January 1, 2013 and December 31, 2022 or the latest available date that allows at least 3 months follow-up | |
Secondary | Molecular diagnostics status | Descriptive analysis of clinical characteristics: Descriptive statistics will be calculated. Categorical variables will be summarized using frequency (number of patients [N]) and percentage (%) of total study persons observed in each group. Continuous and count variables will be presented as the mean, standard deviation (SD) and median. As relevant, continuous variables will also be categorized into intervals. | Retrospective analysis between January 1, 2013 and December 31, 2022 or the latest available date that allows at least 3 months follow-up | |
Secondary | Regorafenib dose at starting treatment and changes during treatment | Descriptive analysis of clinical characteristics: Descriptive statistics will be calculated. Categorical variables will be summarized using frequency (number of patients [N]) and percentage (%) of total study persons observed in each group. Continuous and count variables will be presented as the mean, standard deviation (SD) and median. As relevant, continuous variables will also be categorized into intervals. | Retrospective analysis between January 1, 2013 and December 31, 2022 or the latest available date that allows at least 3 months follow-up | |
Secondary | Biomarkers: KRAS, NRAS & BRAF and MMR/MSI | Retrospective analysis between January 1, 2013 and December 31, 2022 or the latest available date that allows at least 3 months follow-up | ||
Secondary | Proportion of patients in the sequential treatment groups who received myelopoiesis supporting therapy, differentiating between prophylactic and for therapeutic purpose | Myelopoiesis supporting therapy including blood / blood cell transfusions, hematopoietic growth factors, e.g., granulocyte colony stimulating factor and erythropoiesis-stimulating agents. | Retrospective analysis between January 1, 2013 and December 31, 2022 or the latest available date that allows at least 3 months follow-up |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01228734 -
A Trial to Compare Oxaliplatin, Folinic Acid (FA) and 5-Fluorouracil (5FU) Combination Chemotherapy (FOLFOX-4) With or Without Cetuximab in the 1st Line Treatment of Metastatic Colorectal Cancer (mCRC) in Chinese Rat Sarcoma Viral Oncogene Homolog (RAS) Wild-type Patients
|
Phase 3 | |
Completed |
NCT05178745 -
A Prospective Observational Cohort Study Evaluating Resection Rate in Patients With Metastatic Colorectal Cancer Treated With Aflibercept in Combination With FOLFIRI - Observatoire résection
|
||
Completed |
NCT01591421 -
P13Kinase Inhibitor BKM120 in Combination With Panitumumab in Metastatic/Advanced RAS-Wild Type Colorectal Cancer.
|
Phase 1/Phase 2 | |
Withdrawn |
NCT05412706 -
Niraparib Maintenance Treatment in mCRC With a Partial o Complete Response After Oxaliplatin-based Induction Therapy
|
Phase 2 | |
Withdrawn |
NCT04430985 -
FOLFOX + Immunotherapy With Intrahepatic Oxaliplatin for Patients With Metastatic Colorectal Cancer
|
Phase 2 | |
Withdrawn |
NCT03182894 -
Epacadostat in Combination With Pembrolizumab and Azacitidine in Subjects With Metastatic Colorectal Cancer
|
Phase 1/Phase 2 | |
Recruiting |
NCT05725200 -
Study to Investigate Outcome of Individualized Treatment in Patients With Metastatic Colorectal Cancer
|
Phase 2 | |
Terminated |
NCT03176264 -
PDR001 in Combination With Bevacizumab and mFOLFOX6 as First Line Therapy in Patients With Metastatic MSS Colorectal Cancer
|
Phase 1 | |
Completed |
NCT04866290 -
HepaSphere™ Microspheres Prospective Registry
|
||
Not yet recruiting |
NCT06425133 -
Regorafenib in Combination With Multimodal Metronomic Chemotherapy for Chemo-resistant Metastatic Colorectal Cancers
|
Phase 2 | |
Not yet recruiting |
NCT05531045 -
18FFDG PET/CT for Early Evaluation of Chemotherapy Efficacy in Metastatic Colic Adenocarcinoma
|
||
Withdrawn |
NCT03982173 -
Basket Trial for Combination Therapy With Durvalumab (Anti-PDL1) (MEDI4736) and Tremelimumab (Anti-CTLA4) in Patients With Metastatic Solid Tumors
|
Phase 2 | |
Completed |
NCT02906059 -
Study of Irinotecan and AZD1775, a Selective Wee 1 Inhibitor, in RAS or BRAF Mutated, Second-line Metastatic Colorectal Cancer
|
Phase 1 | |
Active, not recruiting |
NCT02575378 -
Maintenance Treatment With Capecitabine Metronomic Chemotherapy and Chinese Traditional Medicine in Metastatic Colorectal Cancer
|
Phase 4 | |
Withdrawn |
NCT02535988 -
Abscopal Effect for Metastatic Colorectal Cancer
|
Phase 2 | |
Recruiting |
NCT02848807 -
Chemotherapy-related Toxicity, Nutritional Status and Quality of Life
|
N/A | |
Active, not recruiting |
NCT02077868 -
Evaluation of MGN1703 Maintenance Treatment in Patients With mCRC With Tumor Reduction During Induction Treatment
|
Phase 3 | |
Completed |
NCT02414009 -
Study to Compare CAPTEM vs FOLFIRI as Second Line Treatment in Advanced, Colorectal Cancer Patients
|
Phase 2 | |
Active, not recruiting |
NCT01949194 -
Study to Determine the Efficacy of Regorafenib in Metastatic Colorectal Cancer Patients and to Discover Biomarkers
|
Phase 2 | |
Withdrawn |
NCT01915472 -
A Phase II Study of IMMU 130 in Patients With Metastatic Colorectal Cancer
|
Phase 2 |