At a glance
ClinicalIndex Comparison Record- ✓Previously untreated, biopsy-proven stage T3-4 and/or N+, resectable rectal adenocarcinoma
- ✓Tumors located within 12 cm of anal verge
- ✓Age 18-70 years
- ✓Male or non-pregnant female
- ✕Evidence of relapse or distant metastasis
- ✕Receiving treatment with other anti-cancer drugs or methods
- ✕Low compliance; unable to complete entire trial
- ✕Uncontrolled life-threatening diseases
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
NCT03466424N/ARecruitingUpdate OverdueUpdated 40mo ago · Completion was 13mo agoPhase I Trial of Dose-escalation Preoperative Short-course Radiotherapy (5×6Gy/7Gy/8Gy) Followed by Neo-adjuvant Chemotherapy in Locally Advanced Rectal Cancer : the FJUHR-01 Trial
In Brief
An observational study evaluating preoperative short-course radiotherapy for Radiation Oncology and Rectal Cancer. Currently recruiting, targeting 9 participants across 1 site.
Signals
Detailed Summary
Preoperative radiotherapy followed by total mesorectal excision (TME) has been recommended as the preferred treatment method for locally advanced rectal cancer. Similar rates of local control, survival and toxicity were observed in preoperative long-course radiotherapy (LCRT) (45-50.4 Gy in 25-28 fractions) and short-course radiotherapy (SCRT) of 25 Gy in five fractions. For the convenience of SCRT, a growing number of patients tend to receive SCRT as preoperative radiotherapy. Although SCRT can shorten treatment interval and cut down the cost of treatment, it's pathological complete response (pCR) rate is relatively low (SCRT vs. LCRT: 0.7% vs. 16%). Hence, the optimal pattern of preoperative therapy of locally advanced rectal cancer still deserves to be explored. Previous studies have confirmed the feasibility and safety of 30Gy/5 fractions in SCRT of rectal cancer and verified that SCRT followed by mFOLFOX6 chemotherapy can improve the pCR rates. Therefore, investigators aimed to establish a dose escalation mode of SCRT (5×6Gy/7Gy/8Gy) followed by four cycles of modified FOLFOX6(mFOLFOX6) chemotherapy to test the safety and efficacy in treating locally advanced rectal cancer.
Study Details
Timeline
Interventions
Patients will be enrolled into Group 1 to 3 according to the time order of entering the study to receive dose from 6Gy×5F to 8Gy×5F using the traditional 3+3 dose escalation design.