An investigator-initiated trial to investigate the utility of LUNAR-1 in colorectal cancer patients with resectable distant metastases - COSMOS-CRC-03

Oki Eiji0 sites160 target enrollmentOctober 5, 2022

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: patients scheduled for curative resection for metastasis of colorectal cancer
Sponsor: Oki Eiji
Enrollment: 160
Status: Recruiting
Last Updated: 2 years ago

No summary available.

Registry

who.int

Start Date

October 5, 2022

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

Oki Eiji

•1\.The patient was diagnosed with colorectal cancer based on histological diagnosis of the primary lesion.
•2\.The following metastatic lesions have been clinically diagnosed from colorectal cancer (regardless of whether they are synchronous or metachronous). Metastases involving multiple organs are also eligible.
•1\)lung metastasis (Less than 5 in preoperative diagnosis)
•2\)liver metastasis (any number)
•3\)peritoneal metastasis (Less than 5 in preoperative diagnosis)
•4\)extra\-regional lymph node metastasis (Less than 3 in preoperative diagnosis)
•5\)ovarian metastasis
•6\)other metastases, such as adrenal or splenic metastases (confirm with coordinating physician prior to enrollment)
•3\.The distant metastases are diagnosed by one of following tests.
•1\)Chest CT (5 mm slices) (both plain and contrast\-enhanced CT are acceptable)

•1\.The patient has active multiple cancer (synchronus multiple cancers, and metachronus multiple cancers with a disease\-free period of 5 years or less. However, patients with intraepithelial or intramucosal cancer in any organ that is determined to have been cured with localized therapy can be enrolled)
•2\.In the case of female patients, the patient is possibly pregnant or is breastfeeding.
•3\.The patient has concurrent interstitial pneumonia, pulmonary fibrosis or severe emphysema.
•4\.The patient has concurrent psychiatric disease or psychiatric symptoms determined to make it difficult for the patient to participate in the clinical trial.
•5\.The patient is receiving continuous systemic steroid therapy (oral or intravenous).
•6\.The patient has concurrent diabetes mellitus that is being treated with continuous insulin administration or is poorly controlled.
•7\.The patient has concurrent poorly controlled hypertension.
•8\.The patient has a history of one or more of the following: serious heart disease, cardiac failure, myocardial infarction within the past 6 months or angina attacks within the past 6 months.
•9\.Patients whom the PI or investigators decided as inappropriate for the clinical trial.