Actively Recruiting
Short-course Radiotherapy (5×6Gy/7Gy/8Gy) Followed by Neo-adjuvant Chemotherapy for Locally Advanced Rectal Cancer
Led by Fujian Medical University Union Hospital · Updated on 2023-02-16
9
Participants Needed
1
Research Sites
226 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Short-course Radiotherapy (5×6Gy/7Gy/8Gy) Followed by Neo-adjuvant Chemotherapy for Locally Advanced Rectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Previously untreated, biopsy-proven stage T3-4 and/or N+ resectable rectal adenocarcinoma with tumors located within 12 cm of the anal verge
- Male or non-pregnant female
- Between 18 and 70 years of age
- Adequate blood cell counts: white blood cells 24,000/mm3, neutrophils 21,500/mm3, platelets 10,000/bcL, hemoglobin 9 g/L
- Adequate kidney function: creatinine 1.5 times upper normal limit
- Adequate liver function: total bilirubin and liver enzymes less than 2.0 times upper normal limit
- Karnofsky Performance Status of 70 or higher
- Ethics committee approval and written informed consent obtained before registration
You will not qualify if you...
- Evidence of cancer relapse or distant metastasis
- Currently receiving other anti-cancer treatments
- Low compliance or inability to complete the entire trial
- Presence of uncontrolled life-threatening diseases
- Dysfunction of heart, brain, lung, or other major organs
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Fujian Medical University Union Hospital
Fuzhou, Fujian, China, 350000
Actively Recruiting
Research Team
B
Benhua Xu
CONTACT
M
Mengxia Zhang
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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