Rectal CancerPhase 2CORTNCT04801511
Preoperative IMRT With Concurrent High-dose Vitamin C and mFOLFOX6 in Locally Advanced Rectal Cancer
A Phase 2 study testing Vitamin C in people with Rectal Cancer, run by Zhou Fuxiang at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- Vitamin C
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 8 Mar 2021to 31 Dec 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongnan Hopital of Wuhan University
Wuhan, Hubei, 430071
Fuxiang Zhou, M.D, +86-027-67813155, happyzhoufx@sina.com
About this study
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.
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.
Read the 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.
- Conditions
- Rectal Cancer
- Being tested
- Vitamin C
- Keywords
- Rectal Cancer, neoadjuvant, chemoradiotherapy, Vitamin C
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin CDrug
Also called ascorbic acid
High-dose Intravenous Vitamin C will be delivered on the day of radiotherapy, in order to reduce the acute toxicity of chemoradiotherapy.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Vitamin C |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 year From the first subject underwent surgery to the last subject underwent surgery.
Secondary outcomes (4)
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.
Measured: 2 year
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.
Measured: 2 year From the first subject underwent surgery to the last subject underwent surgery.
2-year survival rate
2-year survival rate of ITT (Intent to treat) population.
Measured: up to 2 years after the last subject being enrolled
2-year disease-free survival rate
2-year disease-free survival rate of ITT population.
Measured: up to 2 years after the last subject being enrolled.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2021
- Study start8 Mar 2021 (estimated)
- Primary completion30 Jun 2023 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhou Fuxiang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhou Fuxiang, Zhongnan Hospital
- Investigators
- Fuxiang Zhou, M.D., Study chair, Zhongnan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04801511
- Sponsor's protocol ID
- HCCSC R02
- Acronym
- CORT
- Status last verified
- Mar 2021
- First submitted
- 11 Mar 2021
- Last updated
- 17 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04801511
- Acronym / sponsor ID
- CORT / HCCSC R02
- Conditions
- Rectal Cancer
- Keywords
- Rectal Cancer, neoadjuvant, chemoradiotherapy, Vitamin C
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Zhou FuxiangUniversity, hospital or other
- Study start
- 8 Mar 2021 (estimated)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 17 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Drug: Vitamin CPreoperative 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- With metastatic disease.
- Prior radiotherapy or chemotherapy.
- The presence of other cancers.
- Clinically significant cardiac disease.
- Known peripheral neuropathy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin CAlso: ascorbic acidHigh-dose Intravenous Vitamin C will be delivered on the day of radiotherapy, in order to reduce the acute toxicity of chemoradiotherapy. | Drug | Experimental |
Primary outcome
PCR rate
Time frame: 2 year From the first subject underwent surgery to the last subject underwent surgery.
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.
4 secondary outcomes
acute toxicity
Time frame: 2 year
Resection rate of anus preserving surgery
Time frame: 2 year From the first subject underwent surgery to the last subject underwent surgery.
2-year survival rate
Time frame: up to 2 years after the last subject being enrolled
2-year disease-free survival rate
Time frame: up to 2 years after the last subject being enrolled.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fuxiang Zhou, M.D. study chair
Zhongnan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vitamin C in people with Rectal Cancer, run by Zhou Fuxiang at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fuxiang Zhou, M.D. (08602767813155, fuxiang.zhou@whu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PCR rate (time frame: 2 year From the first subject underwent surgery to the last subject underwent surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2021; AzTrials last refreshed its copy on 6 Nov 2026.