patients who underwent R0 resection of distant metastases of colorectal cancer ctDNA, colorectal cancer, oligometastasis
Conditions
Interventions
None listed
Sponsors
Oki Eiji
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)The patient was diagnosed with colorectal cancer based on histological diagnosis of the primary lesion. (2)Following metastatic lesions originated from colorectal cancer (either synchronous or metachronous) received R0 surgical resection. 1)Lung metastasis (up to five lesions) 2)Liver metastasis (regardless of the number of lesions) 3)Peritoneal metastasis (up to five lesions) 4)Distant lymph node metastasis (up to three lesions) 5)Ovarian metastasis 6)Other metastasis including adrenal glands or spleen (The principal investigator should be consulted before enrollment.) (3)The metastatic lesions identified in (2) have been diagnosed within 8 weeks before enrollment with the imaging as described in 1) to 3) below. 1)Chest computed tomography (CT) (5 mm of slice thickness) (with or without a contrast agent) 2)Upper abdomen CT with a contrast agent* (5 mm slice thickness) or upper abdomen magnetic resonance imaging (MRI) (5 mm of slice thickness) 3)Pelvis CT with a contrast agent* (5 mm slice thickness) or pelvis MRI (5 mm of slice thickness) * If allergic to contrast agents, CT without a contrast agent is acceptable. (4)The primary lesion and metastatic lesions have been R0 resected. For resection of distant metastatic lesions, only one-step surgery is acceptable. If metastatic lesions are present in both the left and right lungs, two-step surgery within 28 days will be permitted (the principal investigator should be consulted in case it exceeds 28 days). That is, one of the following conditions is met. 1)R0 resection was performed for the primary lesion and distant metastases (resection of the primary and metastatic lesions as a two-step surgery within 28 days will be permitted, but the resection of the primary lesion should precede). 2)R0 resection for the primary lesion had been performed before, and the first R0 resection for distant metastases was performed. 3)R0 resection for the primary and distant metastatic lesions had been performed before, and R0 resection for distant metastases was performed. * For liver resection specimen, it should be considered R0 resection if the tumor is present on the dissected edge or surgical dissection surface of a liver resection specimen but is covered by a membrane. (5)If the patient has the history of chemotherapy or radiotherapy for the primary lesion and/or metastatic lesions, it should meet either of the conditions 1) or 2) below. 1)Chemotherapy for the primary lesion and/or metastatic lesions was performed. * Chemotherapy of less than one course will not be considered as perioperative chemotherapy. 2)Preoperative radiotherapy was performed for the primary lesion and/or metastatic lesions which had been surgically R0 resected in the past (excluding the metastatic lesions surgically resected just prior to the enrollment to the study). (6)The patient has no history of cryotherapy or thermocoagulation therapy such as radiofrequency cauterization for the metastases in liver and/or lungs surgically resected just prior to the enrollment to the study (including concomitant administration at the time of resection of live metastases). (7)Being aged 18 years or above at the time of obtaining written consent. (8)ECOG Performance Status (PS) of 0 or 1. For patients aged 75 years or above, only a PS 0 is acceptable. (9)The patient is able to have blood collected according to the protocol for this study after enrollment. (10)Written consent to pa
Exclusion criteria
Exclusion criteria: (1)The patient has active multiple cancers (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)For female patients, the patient is possibly pregnant or is breastfeeding. (3)The patient has concurrent interstitial pneumonia, pulmonary fibrosis or severe emphysema that requires medical intervention. (4)The patient has concurrent psychiatric disease or psychiatric symptoms determined to make it difficult for the patient to participate in the study. (5)The patient is receiving continuous systemic steroid therapy (oral or intravenous). (6)The patient has poorly controlled concurrent diabetes mellitus. (7)The patient has poorly controlled concurrent 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)The patient has any conditions with which the investigators consider the patients ineligible.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) Relapse-free Survival (RFS) 2) Rate of ctDNA clearance in patients who were ctDNA positive at Day 28 post-surgery and received adjuvant chemotherapy | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Lead time for recurrence 2) positive predictive value (PPV) 3) Negative predictive value (NPV) 4) Overall survival 5) Association between detection of ctDNA and recurrence sites | — |
Contacts
Public ContactKoji Ando
Kyushu University Hospital
Outcome results
None listed