Preoperative IMRT With Concurrent High-dose Vitamin C and mFOLFOX6 in Locally Advanced Rectal Cancer

Rectal Cancer Clinical Trial

— CORT  

Official title:

Safety and Efficacy of Preoperative IMRT (Intensity-modulated Radiation Therapy) With Concurrent High-dose Intravenous Vitamin C and mFOLFOX6 in Locally Advanced Rectal Cancer Patients: a Prospective Study.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04801511
• Other study ID #: HCCSC R02
• Status: Recruiting
• Phase: Phase 2
• Start date: March 8, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2021
• Source: Zhongnan Hospital
• Contact: Fuxiang Zhou, M.D.
• Phone: 08602767813155
• Email: fuxiang.zhou[@]whu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 patients.

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 cycles of mFOLFOX6 chemotherapy, and then after 4 weeks rest, they will continue to complete 3 cycles of preoperative chemotherapy (mFOLFOX6). Radical surgery will be performed at 10-12 weeks after IMRT.

In this study, we will evaluate the safety and effectiveness of the treatment method through the acute toxicity [during CRT (concurrent chemoradiotherapy )], PCR (pathologic complete response) rate, sphincter preserving surgery rate, 2-year survival rate and 2-year disease-free survival rate.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2024
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. 18 to 75 years of age with a confirmed histopathologic diagnosis of adenocarcinoma of the rectum and considered suitable for curative resection.

2. 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.

3. 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)

4. Laboratory examination showed that glucose-6-phosphate dehydrogenase (G6PD) was normal.

5. The patient agreed and had signed the informed consent

Exclusion Criteria:

1. With metastatic disease.

2. Prior radiotherapy or chemotherapy.

3. The presence of other cancers.

4. Clinically significant cardiac disease.

5. Known peripheral neuropathy.

6. With intestinal obstruction, intestinal perforation or tumor bleeding who need emergency operation.

7. Rectal cancer with signet-ring cell carcinoma, or with Neuroendocrine tumor.

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms

Intervention

Drug:
• Vitamin C
High-dose Intravenous Vitamin C will be delivered on the day of radiotherapy, in order to reduce the acute toxicity of chemoradiotherapy.

Locations

Country	Name	City	State
China	Zhongnan Hopital of Wuhan University	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Zhou Fuxiang

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PCR rate	The PCR rate is defined as the percentage of subjects who achieved Pathological complete remission(PCR) in the total number of the subjects who underwent surgery in the ITT population.	2 year From the first subject underwent surgery to the last subject underwent surgery.
Secondary	acute toxicity	acute toxicity including diarrhea, vomiting leukopenia, er al, during the preoperative CRT and high-dose intravenous vitamin C and 30 after the radiotherapy.	2 year
Secondary	Resection rate of anus preserving surgery	In patients with low rectal cancer, the percentage of subjects who underwent anus preserving surgery accounted for the total TME surgery.	2 year From the first subject underwent surgery to the last subject underwent surgery.
Secondary	2-year survival rate	2-year survival rate of ITT (Intent to treat) population.	up to 2 years after the last subject being enrolled
Secondary	2-year disease-free survival rate	2-year disease-free survival rate of ITT population.	up to 2 years after the last subject being enrolled.