Lower rectal cancer with suspected lateral pelvic node metastasis
Conditions
Interventions
A: T(S)ME+LND and postoperative chemotherapy (mFOLFOX 12 cycles)
B: preoperative chemotherapy (mFOLFOX 6 cycles), T(S)ME+LND, and postoperative chemotherapy (mFOLFOX 6 cycles)
Sponsors
Japan Clinical Oncology Group (JCOG)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Pathologically proven adenocarcinoma or adenosquamous carcinoma 2. Primary tumor located at Upper rectum, Lower rectum, and Anal canal 3. The lower border of the tumor located between the peritoneal reflection and the anal verge 4. cT2, cT3, and cT4 tumor on contrast-enhanced CT or MRI, except T4b tumor invading the trigone of bladder, urethra, or sacrum 5. Lateral lymph nodes with 10mm or more in short axis diameter on contrast-enhanced CT or MRI data of 5mm-thickness slices (cN3) 6. No distant metastasis on contrast-enhanced CT or MRI (cM0) 7. Aged 20 to 74 years old 8. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 9. No prior chemotherapy or treatment such as rectal resection, pelvic lymph node dissection, or pelvic irradiation for any malignancies 10. No other colorectal carcinoma, except cTis or cT1a 11. Adequate organ function as evidenced by the following laboratory studies within 14 days prior to enrollment 1) Neutrophil count >= 1,500 /mm3 2) Platelet count >= 100,000 /mm3 3) T.Bil =< 2.0 mg/dL 4) AST =< 100 IU/L 5) ALT =< 100 IU/L 6) Cr =< 1.5 mg/dL 12. Open surgery will be performed 13. Written informed consent
Exclusion criteria
Exclusion criteria: 1) Synchronous or metachronous (within 5 years) malignancies other than carcinoma in situ or mucosal carcinoma 2) Infectious disease to be treated 3) Positive for HBs antigen 4) Body temperature >= 38 degrees Celsius 5) Women during pregnancy, possible pregnancy or breast-feeding 6) Severe mental disease 7) Currently treated with systemic steroids or immunosuppressive agents 8) Interstitial pneumonia, pulmonary fibrosis, or severe emphysema on chest CT 9) Uncontrollable diabetes mellitus or routine administration of insulin 10) Unstable angina pectoris or previous myocardial infarction within the past 6 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase II: Proportion of patients with R0 resection, Phase III: Overall survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Phase II part: Proportion of operative complication, Proportion of patients who complete 12 cycles of chemotherapy Phase III part: Progression-free survival, Local progression-free survival, Proportion of patients with R0 resection, Overall response rate of preoperative chemotherapy (Group B), Pathological complete response rate (Group B), Proportion of patients who complete 12 cycles of chemotherapy, Incidence of adverse events, Incidence of serious adverse events, Proportion of operative complication, Proportion of preservation of adjacent organs, Proportion of anus-preservation, Proportion of anus-preservation without stoma | — |
Countries
Japan
Contacts
Public ContactMasayuki Ohue, Satoru Iwasa
JCOG1310 Coordinating Office (1)Osaka Medical Center for Cancer & Cardiovascular Diseases (2)National Cancer Center Hospital
Outcome results
None listed