Status:
UNKNOWN
Preoperative IMRT With Concurrent High-dose Vitamin C and mFOLFOX6 in Locally Advanced Rectal Cancer
Lead Sponsor:
Zhou Fuxiang
Conditions:
Rectal Cancer
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of preoperative chemoradiotherapy (IMRT) with concurrent high-dose intravenous vitamin C and mFOLFOX6 in locally advanced rectal cancer...
Detailed Description
Sixty patients with locally advanced rectal cancer (cT3-4N0M0, cT1-4N1-2M0, ≤12cm from anus) will be enrolled and receive preoperative IMRT concurrent with high-dose intravenous vitamin C and 2-3 cycl...
Eligibility Criteria
Inclusion
- 18 to 75 years of age with a confirmed histopathologic diagnosis of adenocarcinoma of the rectum and considered suitable for curative resection.
- Tumors were clinically confirmed (by MRI or CT plus endorectal ultrasound) as stage II (cT3-4N0) or stage III (cT1-4N1-2), with a positive node defined as ≥1.0 cm in diameter on imaging) and a distal border located , 12 cm from the anal verge.
- Patients were required to have an Eastern Cooperative Oncology Group performance status ≤ 1 and adequate hematologic, liver, and renal function. (HGB≥90g/L, WBC≥3.5×10\^9/L, PLT≥90×10\^9/L；ALT / AST≤2.5× ULN；T BILL≤1.5×ULN，Cr ≤1.5×ULN)
- Laboratory examination showed that glucose-6-phosphate dehydrogenase (G6PD) was normal.
- The patient agreed and had signed the informed consent
Exclusion
- With metastatic disease.
- Prior radiotherapy or chemotherapy.
- The presence of other cancers.
- Clinically significant cardiac disease.
- Known peripheral neuropathy.
- With intestinal obstruction, intestinal perforation or tumor bleeding who need emergency operation.
- Rectal cancer with signet-ring cell carcinoma, or with Neuroendocrine tumor.
Key Trial Info
Start Date :
March 8 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04801511
Start Date
March 8 2021
End Date
December 31 2024
Last Update
March 17 2021
Active Locations (1)
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1
Zhongnan Hopital of Wuhan University
Wuhan, Hubei, China, 430071