Stage II and Stage IIIA/B Colon Cancer in Japan
Conditions
Interventions
None listed
Sponsors
Yokohama City University school of Medicine, Department of Biostatistics
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Physician who makes adjuvant chemotherapy treatment recommendations and delivers treatments to patients with stage II or stage III Japanese colon cancer (including Recto-sigmoid colon cancer) 2. Treating physician determines that Oncotype DX testing may contribute to adjuvant decision making for the patient. 3. Patient is willing to consider receiving or not receiving Fluoropyrimidine based plus oxaliplatin adjuvant chemotherapy based on the results of the Oncotype DX assay. 4. Patient must be Japanese and 20 years or older. 5. ECOG Performance Status 0 or 1. 6. Pathologically confirmed colon adenocarcinoma as a primary focus. 7. Surgical and resected specimen findings confirm that the main tumor located at caecum, colon, and recto-sigmoid colon. 8. Tumor has completely resected with both macroscopically and microscopically. 9. The final staging is either Stage II, stage IIIA , or stage IIIB colon cancer. 10. Must be a candidate for treatment of their cancer with systemic adjuvant chemotherapy, including Fluoropyrimidine plus oxaliplatin chemotherapy and can start treatment within 8 weeks after operation. 11. Must have sufficient invasive colon cancer tissue available for submission to Genomic Health in accordance with the Oncotype DX Pathology Guidelines (to be made available upon study initiation). 12. Patient has signed the Informed Consent Form.
Exclusion criteria
Exclusion criteria: 1.A past history of colon cancer prior to the current diagnosis. Patients who had completely endoscopically resected intra mucosal cancer (gastric, colon and esophagus), cured cervical cancer, cured skin basal cell carcinoma, and skin squamous cell carcinoma with more than 5 years of DFS can be included. 2.Simultaneous multiple/ double cancer 3.previous radiation therapy to the site of tumor tissue 4.Perforations or obstructions related to current diagnosis 5.Previous history of neo-adjuvant or adjuvant chemotherapy using Fluoropyrimidine based or platina based chemotherapy for cancer (except hormonal therapy). 6.Known DPD deficiency. 7.Known MMR-D (MSI-H) by local assessment. 8.Physician determines that the patient is not appropriate as a candidate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assess the changing rate of the adjuvant chemotherapy regimen after discussing the result of the Oncotype DX Colon Cancer Assay | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.The proportion of treatment recommendations that change in patients with stage II colon cancer 2.The proportion of treatment recommendations that change in patients with stage IIIA/B colon cancer 3.For each stage of disease (stage II and stage IIIA/B), the proportion of recommendations for observation only, Fluoropyrimidine-based chemotherapy or Fluoropyrimidine-based plus Oxaliplatin chemotherapy by RS defined groups at pre- and post-assay timepoints 4.Differences in the expressed level of confidence in the treatment recommendation as measured by the responses to the item regarding physician confidence in the pre- and post-assay questionnaires for all patients and for patients within each stage of disease (stage II and stage IIIA/B tumors) | — |
Countries
Japan
Contacts
Public ContactSayoko Nakashima
Yokohama City University hospital YCU Center for Novel and Exploratory Clinical Trials
Outcome results
None listed