臨床研究等提出・公開システム

Date of registration	Dec. 03, 2025
Last modified on	Dec. 03, 2025
Trial ID	jRCT1031250545

Scientific Title	A natural history study of patients with previously untreated stage II/III dMMR/MSI-H locally advanced rectal cancer-Japan
Public Title	A natural history study of patients with previously untreated stage II/III dMMR/MSI-H locally advanced rectal cancer-Japan

Contact for Scientific Queries	Name	Suzuki Takeo
	Affiliation	GlaxoSmithKline K.K.
	Address	Akasaka Intercity AIR, 1-8-1 Akasaka, Minato-ku, Tokyo, Japan
	Telephone	+81-120-561-007
	E-mail	jp.gskjrct@gsk.com
Contact for Public Queries	Name	Suzuki Takeo
	Affiliation	GlaxoSmithKline K.K.
	Address	Akasaka Intercity AIR, 1-8-1 Akasaka, Minato-ku, Tokyo, Japan
	Telephone	+81-120-561-007
	E-mail	jp.gskjrct@gsk.com

Recruitment status	Pending

Anticipated date of first enrollment		Dec. 03, 2025
Target sample size		13
Study Type		Observational
Key inclusion & exclusion 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	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.
	Age Minimum	20age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		stage II/III dMMR/MSI-H locally advanced rectal cancer
Intervention(s)		N/A
Primary Outcome(s)		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 Outcome(s)		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.

Primary Sponsor	Suzuki, Takeo

Name of Certified Review Board	Non-Profit Organization MINS Institutional Review Board
Address	5-20-9-401 Mita, Minato-ku, Tokyo
Telephone	+81-3-6416-1868
E-Mail	npo-mins@j-irb.com
Approval Status	Approval
Date of approval	Nov. 20, 2025

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none