The mCRC Patients With pMMR/MSS or dMMR/MSI-H Status Received Palliative Chemotherapy Efficacy and Survival

Colorectal Cancer Metastatic Clinical Trial

Official title:

The Metastatic Colorectal Cancer Patients With Proficient Mismatch Repair (pMMR) / Microsatellite Stable (MSS) or Deficient Mismatch Repair (dMMR) / Microsatellite Instability High (MSI-H) Status Received Palliative Chemotherapy Efficacy and Survival

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04482608
• Other study ID #: dMMR/MSI-H and chemotherapy
• Status: Completed
• Start date: September 1, 2019
• Est. completion date: June 8, 2020

Study information

• Verified date: July 2020
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Deficient mismatch repair (dMMR) or microsatellite instability high (MSI-H) accounts for 4-5% in metastatic colorectal cancer (mCRC). The efficacy and survival of patients with dMMR/MSI-H status received palliative chemotherapy have not clear yet. In this study, the investigators observed the efficacy and survival of dMMR/MSI-H status mCRC patients received palliative first-line chemotherapy.

Description:

Colorectal cancer (CRC) is the one of most common cancer in the world. Loss of function of DNA mismatch repair (MMR) is an important mechanism of CRC development. Mutation or modification of MMR genes result in MMR protein deficient (dMMR) and microsatellite instability (MSI). It has been reported that the dMMR or MSI high (MSI-H) phenotype is present in approximately 15-18% of CRC patients. Most dMMR/MSI-H tumors are sporadic CRC, and only approximately 3% of dMMR/MSI-H tumors are Lynch syndrome (LS) or hereditary nonpolyposis colorectal carcinoma (HNPCC).

The dMMR/MSI-H status was reported to be a predictive marker for adjuvant chemotherapy. Multiple retrospective studies showed that dMMR/MSI-H is correlated with a favorable prognosis in stage II/III CRC. Previous studies suggested that dMMR/MSI status may be a predictive marker of decreased benefit form adjuvant monotherapy of 5-fluorouracil (5-FU) in patients with stage II disease, but not in those with stage III disease. For metastatic colorectal cancer (mCRC), the relationship of the MMR/MSI phenotype and prognosis is unclear. Some researchers found that CRC patients with the dMMR/MSI-H phenotype have a worse prognosis. But other researchers thought the dMMR/MSI-H phenotype is no associate to efficacy and survival of palliative chemotherapy, even is benefit for efficacy and survival.Therefore, the aim of this study was to clarify whether the status of dMMR/MSI-H affected progression-free survival (PFS) in mCRC patients who received first-line palliative chemotherapy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 671
• Est. completion date: June 8, 2020
• Est. primary completion date: April 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Age = 18 years old

2. Histologically confirmed Metastatic colorectal adenocarcinoma;

3. Immunohistochemistry confirmed mismatch repair status or polymerase chain reaction (pCR) / next-generation sequencing (NGS) confirmed microsatellite status

4. Received palliative chemotherapy and have complete information of treatment

Exclusion Criteria:

1. Patients have not tested for mismatch repair or microsatellite

2. Patients have not received palliative chemotherapy or received palliative chemotherapy but treatment information incomplete

Related Conditions & MeSH terms

• Colorectal Cancer Metastatic
• Colorectal Neoplasms
• Microsatellite Instability
• Microsatellite Instability High
• Mismatch Repair Deficiency

Locations

Country	Name	City	State
China	Sun yat-sen university cancer center	Guangzhou	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
Sun Yat-sen University	The Second Affiliated Hospital of Kunming Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-Free Survival (PFS)	PFS as measured in accordance with the Response Evaluation Criteria In Solid Tumours (RECIST) version 1.1	up to 24-36 months
Secondary	Response rate	Based on Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1)	From first patient first visit to 6 month after last patient first visit
Secondary	Disease Control Rate (DCR)	Based on Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1)	From first patient first visit to 6 month after last patient first visit
Secondary	Overall survival	The time from registration to death due to any cause, or censored at date last known alive.	up to approximately 9 year