Rectal CancerPhase 2NCT04296240
Induction Chemotherapy for MRF-negative, Moderate-risk, Resectable Middle and Low Rectal Cancer
A Phase 2 study testing Oxaliplatin and capecitabine and Total Mesorectal Excision in people with Rectal Cancer, run by Peking University Cancer Hospital & Institute at 1 site in China.
Trial summary
This study is designed to test the Safety and efficacy of induction and individualized neoadjuvant chemotherapy based on oxaliplatin combined with fluorouracil for MRF-negative, moderate-risk and initially resectable middle and low rectal cancer. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- Oxaliplatin and capecitabine and Total Mesorectal Excision
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 119 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2019to Apr 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • Age ≥18 years and ≤80 years
- ECOG Performance status 0-1
- Histologically confirmed diagnosis of adenocarcinoma of the rectum
- The distance from down verge of tumor to anal-rectal junction (ARJ) ≤8cm based on MRI, or ≤12cm based on sigmoidoscopy;
- Clinical Stage based on MRI
- mrMRF(-)
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- T3c/T3d/T4a, anyN, or T3bN+
- No evidence of distant metastases
- No prior pelvic radiation therapy
- No prior chemotherapy or surgery for rectal cancer
- No active infections requiring systemic antibiotic treatment
- ANC > 1.5 cells/mm3, HGB > 10.0 g/dL, PLT > 100,000/mm3, total bilirubin ≤ 1.5 x ULN, AST≤ 3 x ULN, ALT ≤ 3 x ULN.
- Patients must read, agree to, and sign a statement of Informed Consent prior to participation in this study.
Who cannot join
- • Recurrent rectal cancer
- Primary unresectable rectal cancer. A tumor is considered unresectable when invading adjacent organs and an en-bloc resection will not achieve negative margins.
- The pathological grade was Grade 4, i.e. mucus, signet ring or undifferentiated cancer.
- Creatinine level greater than 1.5 times the upper limit of normal.
- Patients who have received prior pelvic radiotherapy.
- Patients who are unable to undergo an MRI.
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- Patients with a history of a prior malignancy within the past 5 years, except for adequately treated basal cell or squamous cell skin cancer.
- Patients with a history of any arterial thrombotic event within the past 6 months. This includes angina (stable or unstable), MI, TIA, or CVA.
- Other Anticancer or Experimental Therapy.
- Women who are pregnant or breast-feeding.
- Patients with any other concurrent medical or psychiatric condition or disease which would make them inappropriate candidates for entry into this study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality
Aiwen Wu, MD
About this study
Official title: Safety and Efficacy of Induction and Individualized Neoadjuvant Chemotherapy Based on Oxaliplatin Combined With Fluorouracil for MRF-negative, Moderate-risk and Initially Resectable Middle and Low Rectal Cancer
This study is designed to test the Safety and efficacy of induction and individualized neoadjuvant chemotherapy based on oxaliplatin combined with fluorouracil for MRF-negative, moderate-risk and initially resectable middle and low rectal cancer.
Read the detailed description
Preoperative chemoradiation has become standard treatment for stage 2/3 rectal cancer. But for moderate-risk rectal cancer patients, whether neoadjuvant chemotherapy followed with total mesorectal excision is adequate for local control is still unknown. The necessity of preoperative radiotherapy for these patients needs further exploration.
This study is a single-arm, single-center, prospective, phase II clinical study. It is designed to test the efficacy and safety of neoadjuvant chemotherapy for MRF-negative, moderate-risk and initially resectable middle and low rectal cancer.
In this study, patients with MRI defined moderate-risk rectal cancer will receive a three-month neoadjuvant chemotherapy based on Oxaliplatin combined with Fluorouracil(CapeOX,SOX,mFOLFOX6,etc.) and Total mesorectal excision.
Primary Endpoint is pCR rate.Secondary endpoint concludes toxic reactions of neoadjuvant chemotherapy, Incidence of surgical complications and three-year disease-free survival (DFS).
This study is designed to recruit 119 patients in all.
- Conditions
- Rectal Cancer
- Being tested
- Oxaliplatin and capecitabine, Total Mesorectal Excision
- Keywords
- Rectal Cancer, neoadjuvant, chemotherapy
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxaliplatin and capecitabineDrug
Also called antiemetics
Patients receive 5-Fu and oxaliplatin based neoadjuvant chemotherapy for 3 months
Total Mesorectal ExcisionProcedure or surgery
Also called TME
Patient receive total mesorectal excision after neoadjuvant chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| Neoadjuvant chemotherapy | Experimental | Oxaliplatin 130mg/m2 d1 and Capecitabine 1250mg/m2 bid1-14 or other fluorouracils, every 21 or 14 days for 2 to 4 cycles, and efficacy evaluation every 2 cycles; Receives: Drug: Oxaliplatin and capecitabine; Procedure: Total Mesorectal Excision |
What is being measured
The primary outcome is the main question the study is designed to answer.
pathologic complete response rate
the number of patients with pCR divided by the total number of patients
Measured: 30 days
Secondary outcomes (3)
3 year disease-free survival
cumulative rate of survival without cancer after 3 years follow up
Measured: three years after the enrollment
surgical complication rate
rate of patients who had surgical complications during the perioperative period
Measured: 30 days after the operation
Toxicity of neoadjuvant chemotherapy
category and grade of adverse event during neoadjuvant chemotherapy
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2020
- Study start1 Mar 2019
- Primary completionApr 2021 (estimated)
- Study completionApr 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.
- More trials run by Peking University Cancer Hospital & InstituteThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 119 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Cancer Hospital & Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aiwen Wu, Peking University Cancer Hospital & Institute
- Investigators
- Aiwen Wu, Principal investigator, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04296240
- Sponsor's protocol ID
- PKUCH-R03
- Status last verified
- Mar 2020
- First submitted
- 26 Aug 2019
- Last updated
- 5 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Induction and Individualized Neoadjuvant Chemotherapy Based on Oxaliplatin Combined With Fluorouracil for MRF-negative, Moderate-risk and Initially Resectable Middle and Low Rectal Cancer
- ClinicalTrials.gov ID
- NCT04296240
- Acronym / sponsor ID
- PKUCH-R03
- Conditions
- Rectal Cancer
- Keywords
- Rectal Cancer, neoadjuvant, chemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 119 participants (estimated)
- Lead sponsor
- Peking University Cancer Hospital & InstituteUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- Apr 2021 (estimated)
- Study completion
- Apr 2024 (estimated)
- First posted
- 5 Mar 2020 (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.
This study is designed to test the Safety and efficacy of induction and individualized neoadjuvant chemotherapy based on oxaliplatin combined with fluorouracil for MRF-negative, moderate-risk and initially resectable middle and low rectal cancer.
Detailed description
Preoperative chemoradiation has become standard treatment for stage 2/3 rectal cancer. But for moderate-risk rectal cancer patients, whether neoadjuvant chemotherapy followed with total mesorectal excision is adequate for local control is still unknown. The necessity of preoperative radiotherapy for these patients needs further exploration.
This study is a single-arm, single-center, prospective, phase II clinical study. It is designed to test the efficacy and safety of neoadjuvant chemotherapy for MRF-negative, moderate-risk and initially resectable middle and low rectal cancer.
In this study, patients with MRI defined moderate-risk rectal cancer will receive a three-month neoadjuvant chemotherapy based on Oxaliplatin combined with Fluorouracil(CapeOX,SOX,mFOLFOX6,etc.) and Total mesorectal excision.
Primary Endpoint is pCR rate.Secondary endpoint concludes toxic reactions of neoadjuvant chemotherapy, Incidence of surgical complications and three-year disease-free survival (DFS).
This study is designed to recruit 119 patients in all.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant chemotherapy | Experimental | Drug: Oxaliplatin and capecitabine, Procedure: Total Mesorectal ExcisionOxaliplatin 130mg/m2 d1 and Capecitabine 1250mg/m2 bid1-14 or other fluorouracils, every 21 or 14 days for 2 to 4 cycles, and efficacy evaluation every 2 cycles; |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- • Age ≥18 years and ≤80 years
Key exclusion criteria (11 listed)
- • Recurrent rectal cancer
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 |
|---|---|---|
| Oxaliplatin and capecitabineAlso: antiemeticsPatients receive 5-Fu and oxaliplatin based neoadjuvant chemotherapy for 3 months | Drug | Neoadjuvant chemotherapy |
| Total Mesorectal ExcisionAlso: TMEPatient receive total mesorectal excision after neoadjuvant chemotherapy | Procedure or surgery | Neoadjuvant chemotherapy |
Primary outcome
pathologic complete response rate
Time frame: 30 days
the number of patients with pCR divided by the total number of patients
3 secondary outcomes
3 year disease-free survival
Time frame: three years after the enrollment
surgical complication rate
Time frame: 30 days after the operation
Toxicity of neoadjuvant chemotherapy
Time frame: 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2020.
- Individual participant dataSharing planned: No
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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.
Aiwen Wu principal investigator
Peking University Cancer Hospital & Institute
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 Oxaliplatin and capecitabine and Total Mesorectal Excision in people with Rectal Cancer, run by Peking University Cancer Hospital & Institute 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 13 inclusion and 11 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 5 Mar 2020. 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 Xinyu Wang (+8618511834100, wxy_196@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pathologic complete response rate (time frame: 30 days). 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 5 Mar 2020; AzTrials last refreshed its copy on 4 Nov 2026.