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

Primary Purpose

Rectal Cancer

Status

Recruiting

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Vitamin C

About this trial

This is an interventional treatment trial for Rectal Cancer focused on measuring Rectal Cancer, neoadjuvant, chemoradiotherapy, Vitamin C

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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 Criteria:

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.

Sites / Locations

Zhongnan Hopital of Wuhan UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental

Arm Description

Preoperative concurrent chemoradiotherapy and high-dose intravenous vitamin C : The eligible subjects will be treated with concurrent chemoradiotherapy and high-dose intravenous vitamin C preoperatively. IMRT will be delivered to PTV-CTV (plan target volume-clinical target volume) with a dose of 45Gy/25fraction/5weeks. If necessary. During IMRT, 2-3 cycles of concurrent chemotherapy (mFOLFOX6) will be delivered. High-dose intravenous vitamin C ( 24g/d，QD ) will be delivered on the day of radiotherapy from the beginning to the end of IMRT. preoperative consolidation chemotherapy: Three additional cycles of neoadjuvant chemotherapy (mFOLFOX6) will be given after the end of IMRT. TME （total mesorectal excision）or sphincter preserving surgery will be performed approximately the 10th-12th weeks after the end of IMRT. Whether or not to select "watch and wait" needs to refer to the tumor location, tumor regression, surgeon's opinion and patient's will.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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 survival rate

2-year survival rate of ITT (Intent to treat) population.

2-year disease-free survival rate

2-year disease-free survival rate of ITT population.

Full Information

NCT ID

NCT04801511

First Posted

March 11, 2021

Last Updated

March 15, 2021

Sponsor

Zhou Fuxiang

1. Study Identification

Unique Protocol Identification Number

NCT04801511

Brief Title

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

Acronym

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.

Study Type

Interventional

2. Study Status

Record Verification Date

March 2021

Overall Recruitment Status

Recruiting

Study Start Date

March 8, 2021 (Anticipated)

Primary Completion Date

June 30, 2023 (Anticipated)

Study Completion Date

December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Zhou Fuxiang

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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 patients.

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rectal Cancer

Keywords

Rectal Cancer, neoadjuvant, chemoradiotherapy, Vitamin C

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Model Description

Preoperative CRT: The eligible subjects will be treated with concurrent chemoradiotherapy and high-dose intravenous vitamin C. IMRT will be delivered to PTV-CTV (plan target volume-clinical target volume) with a dose of 45Gy/25f. If necessary, additional boost of 5-10Gy will be delivered to PTV-GTV (plan target volume- gross tumor volume). During the IMRT, 2-3 cycles of concurrent chemotherapy (mFOLFOX6) will be delivered. High-dose intravenous vitamin C (24g/d，QD) will be delivered on the day of radiotherapy from the beginning to the end. Three additional cycles of chemotherapy (mFOLFOX6) will be given after radiotherapy. Radical surgery will be performed approximately 10-12 weeks after the end of radiotherapy. Whether or not to select "watch and wait" or sphincter preserving surgery needs to refer to the tumor location, tumor regression, surgeon's opinion and patient's will.

Masking

None (Open Label)

Allocation

N/A

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Experimental

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Vitamin C

Other Intervention Name(s)

ascorbic acid

Intervention Description

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

Primary Outcome Measure Information:

Title

PCR rate

Description

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.

Time Frame

2 year From the first subject underwent surgery to the last subject underwent surgery.

Secondary Outcome Measure Information:

Title

acute toxicity

Description

acute toxicity including diarrhea， vomiting leukopenia, er al, during the preoperative CRT and high-dose intravenous vitamin C and 30 after the radiotherapy.

Time Frame

2 year

Title

Resection rate of anus preserving surgery

Description

In patients with low rectal cancer, the percentage of subjects who underwent anus preserving surgery accounted for the total TME surgery.

Time Frame

2 year From the first subject underwent surgery to the last subject underwent surgery.

Title

2-year survival rate

Description

2-year survival rate of ITT (Intent to treat) population.

Time Frame

up to 2 years after the last subject being enrolled

Title

2-year disease-free survival rate

Description

2-year disease-free survival rate of ITT population.

Time Frame

up to 2 years after the last subject being enrolled.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Criteria: 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Fuxiang Zhou, M.D.

Phone

08602767813155

fuxiang.zhou@whu.edu.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Fuxiang Zhou, M.D.

Organizational Affiliation

Zhongnan Hospital

Official's Role

Study Chair

Facility Information:

Facility Name

Zhongnan Hopital of Wuhan University

City

Wuhan

State/Province

Hubei

ZIP/Postal Code

430071

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Fuxiang Zhou, M.D

Phone

+86-027-67813155

happyzhoufx@sina.com

12. IPD Sharing Statement

Learn more about this trial

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

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