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

NCT04801511 | Unknown Phase 2 DMC

• 1 other identifier: HCCSC R02
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Rectal Cancer

Keywords

Rectal Cancer; neoadjuvant; chemoradiotherapy; Vitamin C

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• acute toxicity

  2 year

• Resection rate of anus preserving surgery

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

• 2-year survival rate

  up to 2 years after the last subject being enrolled

• 2-year disease-free survival rate

  up to 2 years after the last subject being enrolled.

Study Arms (1)

Experimental

EXPERIMENTAL

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.

Drug: Vitamin C

Interventions

Vitamin C DRUG

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

Also known as: ascorbic acid

Experimental

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhou Fuxiang: lead

Study Sites (1)

Zhongnan Hopital of Wuhan University

Wuhan, Hubei, 430071, China

RECRUITING

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Ascorbic Acid

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Study Officials

• Fuxiang Zhou, M.D.

  Zhongnan Hospital

  STUDY CHAIR

Central Study Contacts

Fuxiang Zhou, M.D.

CONTACT

08602767813155; fuxiang.zhou@whu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: professor

Model Details: 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.

Study Record Dates

• First Submitted: March 11, 2021
• First Posted: March 17, 2021
• Study Start: March 8, 2021
• Primary Completion: June 30, 2023
• Study Completion: December 31, 2024
• Last Updated: March 17, 2021

Record last verified: 2021-03

Locations

CN (1)