A phase II/III randomized controlled trial comparing perioperative versus postoperative chemotherapy with mFOLFOX6 for lower rectal cancer with suspected lateral pelvic node metastasis (JCOG1310, PRECIOUS trial)
Phase 2
- Conditions
- ower rectal cancer with suspected lateral pelvic node metastasis
- Registration Number
- JPRN-UMIN000017603
- Lead Sponsor
- Japan Clinical Oncology Group (JCOG)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 330
Inclusion Criteria
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Phase II: Proportion of patients with R0 resection, Phase III: Overall survival
- Secondary Outcome Measures
Name Time Method 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