Locally Advanced Rectal CancerPhase 2NCT04170530
Neoadjuvant mFOLFOXIRI Chemotherapy Alone for Extramural Vascular Invasion Positive Locally Advanced Rectal Cancer
A Phase 2 study testing mFOLFOXIRI in people with Locally Advanced Rectal Cancer, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
Trial summary
Extramural Vascular Invasion Positive(EMVI+) is a high risk of distant metastasis for locally advanced rectal cancer(LARC) after resection. The study is to evaluate the efficacy and safety of mFOLFOXIRI as neoadjuvant chemotherapy alone for EMVI+ LARC. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Locally Advanced Rectal Cancer
- What is being tested?
- mFOLFOXIRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2019to 1 Jan 2022
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged ≥ 18 to 75 years at diagnosis;
- ECOG status 0 or 1;
- Signed informed consent; able to comply with study and/or follow- up procedures;
- Diagnosis of rectal adenocarcinoma;
- Distal border of the tumor must be located < 12 cm from the anal verge;
- MRI examination diagnosed EMVI-positive;
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- Tumor amenable to curative resection;
- Adequate bone marrow, hepatic and renal function as assessed by the following laboratory requirements conducted within 7 days of starting study treatment: (1) Neutrophilic granulocytes ≥ 3.0 x10^9/L, Platelet count ≥ 75 x 10^9/L, Hemoglobin (Hb) ≥ 90g/L; (2) bilirubin ≤1.5 x the upper limit of normal (ULN),Alanine aminotransferase (ALT)/Aspartate aminotransferase (AST) ≤ 2.5 x ULN; (3) Serum creatinine ≤ 1.5 x ULN.
- No renal disease that would preclude study treatment or follow-up
Who cannot join
- Hypersensitivity to fluorouracil, oxaliplatin or irinotecan;
- Patient had received pelvic radiotherapy;
- Patient had received systemic chemotherapy;
- History of invasive colon or rectal malignancy, regardless of disease-free interval;
- Had metastatic disease;
- Patient had second malignant disease within 5 years;
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- Uncontrolled co-morbid illnesses or other concurrent disease;
- Patients refused to signed informed consent.
- Pregnant and Nursing women;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310006
Hua Hanju, M.D, +86 15088779188 ext. 87236858, tomorrow97@163.com
About this study
Official title: Neoadjuvant mFOLFOXIRI Chemotherapy Alone for Extramural Vascular Invasion(EMVI) Positive Rectal Cancer: A Phase II, Single-arm, Prospective Clinical Study
Extramural Vascular Invasion Positive(EMVI+) is a high risk of distant metastasis for locally advanced rectal cancer(LARC) after resection. The study is to evaluate the efficacy and safety of mFOLFOXIRI as neoadjuvant chemotherapy alone for EMVI+ LARC.
Read the detailed description
It is an investigator-initiated, single institution, prospective, single-arm clinical study to evaluate the efficacy and safety of FOLFOXIRI as neoadjuvant chemotherapy alone for EMVI+ LARC.Patients of LARC with EMVI+ evaluated by pelvic magnetic resonance imaging (MRI) were enrolled in this trial. All EMVI+ LARC will receive the study regimen every 2 weeks for 6 cycles. MRI will be performed after 3 cycles of chemotherapy to assess clinical response.MRI was performed to assess clinical response after chemotherapy. Patients with mesorectal fascia-positive or ycT4a/b after re-evaluation would receive radiation before surgery, whereas responders would have immediate total mesorectal excision (TME).If the tumor response is good enough(partial response or complete response), the patient will receive another 3 cycles of FOLFOXIRI then surgery. On the contrary, if the tumor shows poor response(stable disease or progressive disease) or with mesorectal fascia-positive or ycT4a/b after re-evaluation, radiotherapy will be performed combined with capecitabine before operation. All patients will receive 6 cycles of mFOLFOX6 or 4 cycles XELOX as adjuvant chemotherapy after TME.
- Conditions
- Locally Advanced Rectal Cancer
- Being tested
- mFOLFOXIRI
- Keywords
- Extramural Vascular Invasion, Neoadjuvant, chemotherapy, mFOLFOXIRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mFOLFOXIRIDrug
Also called 5-FU, Oxaliplatin, Irinotecan
irinotecan* 135 mg/m² + oxaliplatin 68 mg/m² + leucovorin 400 mg/m² + 5-FU 2400 mg/m² cont. inf. 46h all on day 1 of each 2 weeks cycle
| Study group | Role | What they receive |
|---|---|---|
| mFOLFOXIRI | Experimental | patients received FOLFOXIRI alone for 6 cycles before surgery. Receives: Drug: mFOLFOXIRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
MFS
metastasis free survival
Measured: Three years
Secondary outcomes (7)
Tumor downstaging rate
the proportion of tumor downstaging to ypT0-2N0M0
Measured: 2 years
pCR
Pathologic complete response rate
Measured: 2 years
R0 rate
R0 resection rate
Measured: 2 years
locoregional recurrence
The rate of local recurrence
Measured: 3 years
DFS
disease-free survival
Measured: 3 years
OS
overall survival.
Measured: 5 years
Reported Adverse events
The incidence of >=3 grade adverse events
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2019
- Study start1 Jan 2019
- Primary completion1 Nov 2020 (estimated)
- Study completion1 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Rectal CancerStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Zhejiang UniversityThe 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
- 51 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hanju Hua, First Affiliated Hospital of Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04170530
- Sponsor's protocol ID
- TRICHEMO
- Status last verified
- Nov 2019
- First submitted
- 18 Nov 2019
- Last updated
- 20 Nov 2019
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant mFOLFOXIRI Chemotherapy Alone for Extramural Vascular Invasion(EMVI) Positive Rectal Cancer: A Phase II, Single-arm, Prospective Clinical Study
- ClinicalTrials.gov ID
- NCT04170530
- Acronym / sponsor ID
- TRICHEMO
- Conditions
- Locally Advanced Rectal Cancer
- Keywords
- Extramural Vascular Invasion, Neoadjuvant, chemotherapy, mFOLFOXIRI
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 51 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Zhejiang UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Nov 2020 (estimated)
- Study completion
- 1 Jan 2022 (estimated)
- First posted
- 20 Nov 2019 (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.
Extramural Vascular Invasion Positive(EMVI+) is a high risk of distant metastasis for locally advanced rectal cancer(LARC) after resection. The study is to evaluate the efficacy and safety of mFOLFOXIRI as neoadjuvant chemotherapy alone for EMVI+ LARC.
Detailed description
It is an investigator-initiated, single institution, prospective, single-arm clinical study to evaluate the efficacy and safety of FOLFOXIRI as neoadjuvant chemotherapy alone for EMVI+ LARC.Patients of LARC with EMVI+ evaluated by pelvic magnetic resonance imaging (MRI) were enrolled in this trial. All EMVI+ LARC will receive the study regimen every 2 weeks for 6 cycles. MRI will be performed after 3 cycles of chemotherapy to assess clinical response.MRI was performed to assess clinical response after chemotherapy. Patients with mesorectal fascia-positive or ycT4a/b after re-evaluation would receive radiation before surgery, whereas responders would have immediate total mesorectal excision (TME).If the tumor response is good enough(partial response or complete response), the patient will receive another 3 cycles of FOLFOXIRI then surgery. On the contrary, if the tumor shows poor response(stable disease or progressive disease) or with mesorectal fascia-positive or ycT4a/b after re-evaluation, radiotherapy will be performed combined with capecitabine before operation. All patients will receive 6 cycles of mFOLFOX6 or 4 cycles XELOX as adjuvant chemotherapy after TME.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| mFOLFOXIRI | Experimental | Drug: mFOLFOXIRIpatients received FOLFOXIRI alone for 6 cycles before surgery. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Aged ≥ 18 to 75 years at diagnosis;
- ECOG status 0 or 1;
- Signed informed consent; able to comply with study and/or follow- up procedures;
- Diagnosis of rectal adenocarcinoma;
- Distal border of the tumor must be located < 12 cm from the anal verge;
Key exclusion criteria (9 listed)
- Hypersensitivity to fluorouracil, oxaliplatin or irinotecan;
- Patient had received pelvic radiotherapy;
- Patient had received systemic chemotherapy;
- History of invasive colon or rectal malignancy, regardless of disease-free interval;
- Had metastatic disease;
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 |
|---|---|---|
| mFOLFOXIRIAlso: 5-FU, Oxaliplatin, Irinotecanirinotecan* 135 mg/m² + oxaliplatin 68 mg/m² + leucovorin 400 mg/m² + 5-FU 2400 mg/m² cont. inf. 46h all on day 1 of each 2 weeks cycle | Drug | mFOLFOXIRI |
Primary outcome
MFS
Time frame: Three years
metastasis free survival
7 secondary outcomes
Tumor downstaging rate
Time frame: 2 years
pCR
Time frame: 2 years
R0 rate
Time frame: 2 years
locoregional recurrence
Time frame: 3 years
DFS
Time frame: 3 years
OS
Time frame: 5 years
Reported Adverse events
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2019.
- 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.
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 mFOLFOXIRI in people with Locally Advanced Rectal Cancer, run by First Affiliated Hospital of Zhejiang University 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 9 inclusion and 9 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 20 Nov 2019. 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 Hua M Hanju, M.D (+86 15088779188 ext. 87236858, tomorrow97@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MFS (time frame: Three years). 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 20 Nov 2019.