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Completed

NCT Number: NCT04482608

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

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Sun yat-sen university cancer center

Guangzhou, Guangdong, 510060, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18 years old
  • Histologically confirmed Metastatic colorectal adenocarcinoma;
  • Immunohistochemistry confirmed mismatch repair status or polymerase chain reaction (pCR) / next-generation sequencing (NGS) confirmed microsatellite status
  • Received palliative chemotherapy and have complete information of treatment

Exclusion criteria

  • Patients have not tested for mismatch repair or microsatellite
  • Patients have not received palliative chemotherapy or received palliative chemotherapy but treatment information incomplete

Treatment and study plan

Primary outcomes

  1. Progression-Free Survival (PFS)

    Time frame: up to 24-36 months

    PFS as measured in accordance with the Response Evaluation Criteria In Solid Tumours (RECIST) version 1.1

Secondary outcomes

  1. Response rate

    Time frame: From first patient first visit to 6 month after last patient first visit

    Based on Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1)

  2. Disease Control Rate (DCR)

    Time frame: From first patient first visit to 6 month after last patient first visit

    Based on Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1)

  3. Overall survival

    Time frame: up to approximately 9 year

    The time from registration to death due to any cause, or censored at date last known alive.

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Collaborators

  • The Second Affiliated Hospital of Kunming Medical University

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jul 22, 2020
Registry last updated
Jul 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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