Colon and Rectal cancer that can be treated radically
Conditions
Interventions
None listed
Sponsors
National Research and Development Agency, National Cancer Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Eligible subjects shall meet all of the following. Patients who have recurrence after the initial registration and are eligible for radical surgical resection again can be re-registered. (1)Histopathologically diagnosed with adenocarcinoma. (2)The primary location of the tumor is the colon or rectum. (3) CohortA The clinical stage is equivalent to stage II, III colon cancer (including rectosigmoid) for which R0 resection has been scheduled. CohortB The clinical stage is equivalent to stage II, III rectal cancer (excluding rectosigmoid) for which R0 resection has been scheduled. Patients with lateral lymph node metastasis can be included in this cohort. CohortC The clinical stage is equivalent to stage IV or relapse (M1) colorectal cancer for which R0 resection has been scheduled. CohortD pT1 colorectal cancer after local resection, and additional colorectal resection with lymph node dissection is planned due to non-curative factors. Non-curative factors are as follows 1.T1b (SM invasiveness >1000 um) 2.Positive vascular invasion 3.Poorly differentiated adenocarcinoma, signet-ring cell carcinoma, mucinous carcinoma 4.Presence of individual cells and small clusters of tumor cells at the invasive front of carcinoma (budding) Grade 2/3 CohortE The pathological stage is equivalent to stage IIB, IIC, III colorectal cancer for which R0 resection was performed within 48 weeks prior to enrollment. Rectal cancer (excluding rectosigmoid) with lateral lymph node metastasis can be included in this study. And a standard peri-operative (neoadjuvant/adjuvant) chemotherapy according to the country guideline and/or medical practice is scheduled to be performed, is being performed, or has been performed. (4)The age at the time of acquisition of informed consent is 20 years or older. (5)Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) is 0 or 1. (6)The subject has given a written informed consent for participation in this study.
Exclusion criteria
Exclusion criteria: (1) Two or more synchronous colorectal cancer (multiple cancer) * * In case of patients with stage II, III, IV or recurrent (M1) colorectal cancer according to the 8th edition of the UICC, patients with clinical stage Tis or T1a colorectal cancer judged to be cured by local treatment may be included in this study. * If patients with pT1 colorectal cancer after local resection (complete en bloc resection with negative margins), have other cancers up to clinical stage T1a that can be judged to be cured by local treatment, registration is possible only if it is confirmed that the cancer was radically resected by local treatment. (2) Active double cancer. (3) In case of enrolled in Cohort A or Cohort D, history of surgery, chemotherapy, immunotherapy, or radiotherapy within 6 months before enrollment. (4) Pregnant or breastfeeding women. (5) Serious complication. (6) Positive for HBs antigen or positive for HCV antibody*. *Patients who are positive for HCV antibody but negative for HCV-RNA is eligible. (7) HIV antibody positive (a patient may enroll even if HIV antibody has not been tested). (8) Active novel coronavirus infection (COVID-19) is present*. * Patients with positive SARS-CoV-2 PCR or suspected COVID-19 based on clinical symptoms; patients with confirmed negative SARS-CoV-2 PCR or other tests and no symptoms of COVID-19 may be include in this study. However, if the physician deem that the patients will affect the evaluation of this study, the patients are ineligible. (COVID-19 testing is not required). (9) The study doctor deemed that it is ineligible for this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| All: Disease-free Survival Cohort D: Sensitivity and specificity of ctDNA for the presence of lymph node metastases in additional colorectal resections | — |
Countries
Japan,Asia(except Japan)
Contacts
Public ContactSaori Mishima
National Cancer Center Hospital East, Department of Gastroenterology and GI Oncology
Outcome results
None listed