Locally Advanced Rectal CancerPhase 2NCT03443661
Neoadjuvant Triplet Chemotherapy Regimen in Patients With Locally Advanced Rectal Cancer
A Phase 2 study testing FOLFOXIRI in people with Locally Advanced Rectal Cancer, run by Aiping Zhou at 1 site in China.
Trial summary
This study aims to investigate the feasibility, safety and efficacy of triplet regimen of neoadjuvant chemotherapy in patients with locally advanced rectal cancer Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Locally Advanced Rectal Cancer
- What is being tested?
- FOLFOXIRI
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 6 Feb 2016to 1 Apr 2020
- 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
- Histologically confirmed locally advanced rectal cancer;
- 18-70 years ；
- Clinicalstage:T3,4a,N0,M0;T1-4a,N+,M0;
- Tumor from anus >5cm and ≤15cm;
- ECOG=0-1;
- Available organ function:ALT≤1.5xULN;AST≤1.5xULN;TBIL≤1.0xULN; NEUT≥2×109/L;PLT≥100×109/L;Hb≥90g/L;Creatinine≤1.0xULN;
- Informed consent;
- UGT1A1:UGT1A1*1/UGT1A1*1,UGT1A1*1/UGT1A1*28,UGT1A1*1/UGT1A1*6;
Who cannot join
- Clinical stage T4b or unresectable disease;
- History of pelvic radiotherapy;
- History of chemotherapy within 5 years;
- History of chronic diarrhea;
- Tumor causes intestinal obstruction, intestinal perforation, and severe bleeding;
- Hepatitis B surface antigen positive; Hepatitis C virus infection; Cirrhosis of the liver for any cause;
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- UGT1A1:UGT1A1*28/UGT1A1*28,UGT1A1*6/UGT1A1*6;
- Other cancers in the past 5 years, except for cervical carcinoma in situ or non-melanoma skin cancer;
- Myocardial infarction (in the last 6 months), severe instability angina, congestive heart failure; interstitial pneumonia,pulmonary fibrosis, uncontrolled diabetes, renal insufficiency;
- Mental illness;Pregnant or lactating women;
Trial locations and contacts
1 site in 1 country.
China1 site
National Cancer Center/Cancer Hospital, Chinese ACademy of Medical Sciences and Peking Union Medical College
Beijing, 100021
About this study
Official title: A Pilot Phase II Study of Neoadjuvant Triplet Chemotherapy Regimen （FOLFOXIRI） in Patients With Locally Advanced Rectal Cancer
This study aims to investigate the feasibility, safety and efficacy of triplet regimen of neoadjuvant chemotherapy in patients with locally advanced rectal cancer
Read the detailed description
In this pilot phase II study, the investigators enrolled Chinese adults(age 18 to 70 years) with locally advanced stage II/III rectal cancer. The neuadjuvant chemotherapy regimen is : oxaliplatin 85 mg/m2 and irinotecan 150 mg/m2, combined with 5FU 2,400 mg/m2 by 46 h infusion, repeated at 2week intervals for 5 cycles. Total mesorectal excision was scheduled 4-5 weeks after completion of neoadjuvant treatment and followed by a further 7 cycles of mFOLFOX or 4 cycles of XELOX. Primary outcome measures of this phase II trial were feasibility, safety, tolerance and efficacy of neoadjuvant treatment.
- Conditions
- Locally Advanced Rectal Cancer
- Being tested
- FOLFOXIRI
- Keywords
- 5-Fluorouracil, rectal cancer, irinotecan, oxaliplatin, 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.
FOLFOXIRIDrug
oxaliplatin 85 mg/m2 irinotecan 150 mg/m2, 5FU 2,400 mg/m2 by 46 h infusion repeated at 2week intervals
| Study group | Role | What they receive |
|---|---|---|
| FOLFOXIRI | Experimental | oxaliplatin 85 mg/m2 irinotecan 150 mg/m2, 5FU 2,400 mg/m2 by 46 h infusion repeated at 2week intervals Receives: Drug: FOLFOXIRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
pCR
Pathological complete response according to Mandard tumor regression grading
Measured: 1 year
Secondary outcomes (3)
R0 resection rate
R0 resection rate
Measured: 1 year
locoregional recurrence rate
locoregional recurrence rate
Measured: 1 year
Safety
Including adverse events during neoadjuvant chemotherapy,surgery and perioperative complications
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2018
- Study start6 Feb 2016
- Primary completion1 Mar 2019
- Study completion1 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Locally Advanced 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
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aiping Zhou
- Responsible party
- Sponsor-investigator, Aiping Zhou, Chinese Academy of Medical Sciences
- Investigators
- Aiping Zhou, Doctor, Principal investigator, China National Cancer Center/Cancer Hospital, Chinese ACademy of Medical Sciences and Peking Union Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03443661
- Sponsor's protocol ID
- CH-GI-086
- Status last verified
- Jan 2021
- First submitted
- 14 Jan 2018
- Last updated
- 1 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhang W, Zhou H, Jiang J, Zhu Y, Zou S, Jiang L, Tang Y, Liang J, Sun Y, Jiang Z, Qu W, Li Y, Zhou A. Neoadjuvant chemotherapy with modified FOLFOXIRI for locally advanced rectal cancer to transform effectively EMVI and MRF from positive to negative: results of a long-term single center phase 2 clinical trial. BMC Cancer. 2023 Jun 27;23(1):592. doi: 10.1186/s12885-023-11103-x.
PubMed 37370032
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Phase II Study of Neoadjuvant Triplet Chemotherapy Regimen （FOLFOXIRI） in Patients With Locally Advanced Rectal Cancer
- ClinicalTrials.gov ID
- NCT03443661
- Acronym / sponsor ID
- CH-GI-086
- Conditions
- Locally Advanced Rectal Cancer
- Keywords
- 5-Fluorouracil, rectal cancer, irinotecan, oxaliplatin, neoadjuvant chemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Aiping Zhou
- Study start
- 6 Feb 2016 (actual)
- Primary completion
- 1 Mar 2019 (actual)
- Study completion
- 1 Apr 2020 (actual)
- First posted
- 23 Feb 2018 (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 aims to investigate the feasibility, safety and efficacy of triplet regimen of neoadjuvant chemotherapy in patients with locally advanced rectal cancer
Detailed description
In this pilot phase II study, the investigators enrolled Chinese adults(age 18 to 70 years) with locally advanced stage II/III rectal cancer. The neuadjuvant chemotherapy regimen is : oxaliplatin 85 mg/m2 and irinotecan 150 mg/m2, combined with 5FU 2,400 mg/m2 by 46 h infusion, repeated at 2week intervals for 5 cycles. Total mesorectal excision was scheduled 4-5 weeks after completion of neoadjuvant treatment and followed by a further 7 cycles of mFOLFOX or 4 cycles of XELOX. Primary outcome measures of this phase II trial were feasibility, safety, tolerance and efficacy of neoadjuvant treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FOLFOXIRI | Experimental | Drug: FOLFOXIRIoxaliplatin 85 mg/m2 irinotecan 150 mg/m2, 5FU 2,400 mg/m2 by 46 h infusion repeated at 2week intervals |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Histologically confirmed locally advanced rectal cancer;
- 18-70 years ；
- Clinicalstage:T3,4a,N0,M0;T1-4a,N+,M0;
- Tumor from anus >5cm and ≤15cm;
- ECOG=0-1;
Key exclusion criteria (10 listed)
- Clinical stage T4b or unresectable disease;
- History of pelvic radiotherapy;
- History of chemotherapy within 5 years;
- History of chronic diarrhea;
- Tumor causes intestinal obstruction, intestinal perforation, and severe bleeding;
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 |
|---|---|---|
| FOLFOXIRIoxaliplatin 85 mg/m2 irinotecan 150 mg/m2, 5FU 2,400 mg/m2 by 46 h infusion repeated at 2week intervals | Drug | FOLFOXIRI |
Primary outcome
pCR
Time frame: 1 year
Pathological complete response according to Mandard tumor regression grading
3 secondary outcomes
R0 resection rate
Time frame: 1 year
locoregional recurrence rate
Time frame: 1 year
Safety
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2021.
- Derived from this study: PubMed 37370032Zhang W, Zhou H, Jiang J, Zhu Y, Zou S, Jiang L, Tang Y, Liang J, Sun Y, Jiang Z, Qu W, Li Y, Zhou A. Neoadjuvant chemotherapy with modified FOLFOXIRI for locally advanced rectal cancer to transform effectively EMVI and MRF from positive to negative: results of a long-term single center phase 2 clinical trial. BMC Cancer. 2023 Jun 27;23(1):592. doi: 10.1186/s12885-023-11103-x.
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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.
Aiping Zhou, Doctor principal investigator
China National Cancer Center/Cancer Hospital, Chinese ACademy of Medical Sciences and Peking Union Medical College
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 FOLFOXIRI in people with Locally Advanced Rectal Cancer, run by Aiping Zhou 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 8 inclusion and 10 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: finished, as of the sponsor's last update on 1 Feb 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pCR (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03443661, which also lists 1 linked publication.
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 1 Feb 2021.