stage II/III dMMR/MSI-H locally advanced rectal cancer
Conditions
Interventions
None listed
Sponsors
Suzuki Takeo
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histopathological diagnosis was adenocarcinoma. 2. Diagnosis of the primary tumor location in rectum. 3. Diagnosis of stage II or stage III (T3-T4, N0, or T any, N+) rectal cancer 4. Adults age >-20 years at stage II/III rectal cancer diagnosis date. 5. Initiated SOC therapy (i.e., any observed real-world therapy) for treatment of stage II/III rectal cancer following date of diagnosis 6. Lab results indicating dMMR status or MSI-H phenotype til the timing of disease recurrence. 7. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1. 8. Written consent to participate in the present research has been obtained from the subject in GALAXY study.
Exclusion criteria
Exclusion criteria: 1. Evidence of stage IV rectal cancer on or prior to the date of stage II/III rectal cancer diagnosis. 2. Evidence of radiation therapy, systemic therapy, or surgery for the management of rectal cancer prior to the date of stage II/III rectal cancer diagnosis. 3. Two or more synchronous primary cancers of the large intestine (multiple cancers). 4. Active double cancers are present. However, patients with a recurrence-free period of at least 5 years or patients with basal cell carcinoma or squamous cell carcinoma of the skin, superficial bladder cancer, cervical cancer, lesions equivalent to carcinoma in situ (carcinoma in situ) or intramucosal cancer amenable to endoscopic treatment, non-metastatic prostate cancer, lymphoma not requiring systemic treatment, etc. which are determined to be cured by local treatment can be enrolled. 5. Pregnant or nursing (lactating) women. 6. Hepatitis B surface(HBs) antigen positive or Hepatitis C virus (HCV) antibody positive. -Patients who are HCV antibody positive but Ribonucleic Acid (RNA) negative can be enrolled. 7. Human Immunodeficiency Virus (HIV) antibody positive (patient can be registered even if it has not been tested) 8. Patient treated with investigational drugs before SOC treatment in GALAXY study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The real-world three-year event-free survival proportion (rwEFS3) among Japanese patients with Stage II/III dMMR/MSI-H rectal cancer treated with SOC. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To describe patients' baseline characteristics among patients with Stage II/III dMMR/MSI-H rectal cancer treated with SOC in Japan 2. To estimate the three-year real-world overall survival proportion (rwOS3) among Japanese patients with Stage II/III dMMR/MSI-H rectal cancer treated with SOC. | — |
Contacts
Public ContactTakeo Suzuki
GlaxoSmithKline K.K.
Outcome results
None listed