Colonic NeoplasmsPhase 2NCT03484195
Neoadjuvant FOLFOXIRI Chemotherapy in Patients With Locally Advanced Colon Cancer
A Phase 2 study testing FOLFOXIRI in people with Colonic Neoplasms and Drug Therapy, run by China Medical University, China at 1 site in China.
Trial summary
To evaluate the efficacy and safety of neoadjuvant FOLFOXIRI chemotherapy (irinotecan, oxaliplatin and fluorouracil) in the patients with locally advanced colon cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colonic Neoplasms, Drug Therapy
- 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
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2018to 1 Oct 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 18-75years old
- Primary and pathological diagnosis of colon adenocarcinoma
- Radiographic evaluation of initial resectable colon cancer
- T4b colon cancer
- ECOG status: 0～1
- Adequate bone marrow, hepatic and renal function as assessed by the following laboratory requirements conducted within 7 days of starting study treatment:
- Neutrophil count≥1.5×10^9/L Platelet count≥90×10^9/L Hemoglobin≥90g/L Total bilirubin (TBI) ≤ 1.5 ULN Alanine aminotransferase (ALT)≤2.5 ULN Aspartate aminotransferase (AST)≤2.5 ULN Alkaline phosphatase (ALP)≤2.5 ULN
- Signed informed consent; able to comply with study and/or follow- up procedures
Who cannot join
- Previous treatment with oxaliplatin, irinotecan or fluorouracil
- Hypersensitivity to fluorouracil, oxaliplatin or irinotecan.
- With distant metastasis
- Cardiovascular disease that would preclude study treatment or follow-up; New York Heart Association class III or IV heart disease; active ischemic heart disease; myocardial infarction within the past 6 months; symptomatic arrhythmia uncontrolled hypertension. Unexplained syncope occurred within 3 months
- Digestive system diseases that would preclude study treatment or follow-up within the past 6 months
- Gastric ulcers or duodenal ulcers for the treatment of resistance;
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- 3 or 4 grade gastrointestinal bleeding / bleeding;
- Gastrointestinal perforation / fistula;
- abdominal abscess;
- Infectious or inflammatory bowel disease
- HIV infection and/or active hepatitis B virus infection
- Pregnant or lactating women. Fertile patients must use effective contraception
- Any serious acute or chronic disease that can not be involved in the study or to influence the interpretation of the results of the study
- Other intervention clinical trials were combined at the same time.
- Nerve or mental abnormality affecting cognitive ability
- Other malignancy except effectively treated squamous cell or basal cell skin cancer,
- Other situations that the researchers think should be excluded
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Liaoning Cancer Hospital
Shenyang, Liaoning, 110000
Yuanhe Wang, wangyuanhe@sina.comm
Jingdong Zhang
About this study
Official title: Neoadjuvant FOLFOXIRI (Irinotecan, Oxaliplatin and Fluorouracil) Chemotherapy in Patients With Locally Advanced Colon Cancer：an Open-label, Single-arm, Multicenter Phase II Study
To evaluate the efficacy and safety of neoadjuvant FOLFOXIRI chemotherapy (irinotecan, oxaliplatin and fluorouracil) in the patients with locally advanced colon cancer.
Read the detailed description
For the patients with locally advanced colon cancer, adjuvant FOLFOX and XELOX chemotherapy have become standard treatment. However, 30% - 40% patients suffered from local recurrence or distant metastasis after this standard treatment. Neoadjuvant chemotherapy could shrink tumors, eliminate micrometastasis, reduce surgical trauma and accelerate recovery. Hence, we evaluate the efficacy and safety of FOLFOXIRI as neoadjuvant chemotherapy in treating patients with locally advanced colon cancer.
In this prospective study, 30 patients with locally advanced colon cancer will be treated with 4 cycles of neoadjuvant FOLFOXIRI chemotherapy followed by surgical resection. PET-CT scanning will be performed before and after the neoadjuvant FOLFOXIRI chemotherapy to assess SUVmax changes. The ctDNA in peripheral blood before and after each cycle of neoadjuvant FOLFOXIRI chemotherapy will be detected. In the course of treatment, safety evaluation will be carried out according to adverse reaction classification (CTCAE) 4. 0.
- Conditions
- Colonic Neoplasms, Drug Therapy
- Being tested
- FOLFOXIRI
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FOLFOXIRIDrug
Also called Irinotecan, Oxaliplatin, 5-Fluorouracil
Irinotecan 150 mg/m^2 IV over 1h, day 1 + Oxaliplatin 85 mg/m^2 IV over 2h, day 1 + L-Leucovorin 200 mg/m^2 IV over 2h, day 1 + 5-Fluorouracil 2800 mg/m^2 IV 48h continuous infusion, starting on day 1 administered every two weeks for 4 cycles (2 months)
| Study group | Role | What they receive |
|---|---|---|
| FOLFOXIRI | Experimental | Patients received 4 cycles of neoadjuvant FOLFOXIRI chemotherapy before surgical resection. Receives: Drug: FOLFOXIRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
The ratio of tumor downstaging to stage 0 and stage I
Tumor downstaging from stage II or III to pathologic complete response (stage 0) and stage I
Measured: 2 years
Secondary outcomes (7)
Tumor regression grade (TRG)
The level of tumor regression under pathological examination
Measured: 2 years
Disease free survival
Estimated from the date of surgery to the date of recurrence
Measured: 3 years
Overall survival time
Estimated from the date of enrollment to death from any cause
Measured: 3 years
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
The grade of toxicity will be assessed using the NCI-CTCAE version 4.0
Measured: 3 years
ctDNA change
The relationship between ctDNA and survival will be evaluated
Measured: 3 years
SUVmax changes
Tumor metabolic response through FDG-PET examination before and after 4 cycles of neoadjuvant FOLFOXIRI chemotherapy
Measured: At the begin of Cycle 1 and the end of Cycle 4 (each cycle is 14 days)
Quality of life (QLQ C30)
Scores according to EORTC QLQ-C30 scoring manual
Measured: Every 2 weeks after the first treatment until 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2018
- Study start1 Apr 2018
- Primary completion1 Oct 2021 (estimated)
- Study completion1 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colonic NeoplasmsStudies 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jingdong Zhang, China Medical University, China
- Investigators
- Jingdong Zhang, Study chair, Cancer Hospital of China Medical University, Department of Medical Oncology, Liaoning Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03484195
- Sponsor's protocol ID
- LGIOG-2017-01
- Status last verified
- Apr 2021
- First submitted
- 23 Mar 2018
- Last updated
- 19 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant FOLFOXIRI (Irinotecan, Oxaliplatin and Fluorouracil) Chemotherapy in Patients With Locally Advanced Colon Cancer：an Open-label, Single-arm, Multicenter Phase II Study
- ClinicalTrials.gov ID
- NCT03484195
- Acronym / sponsor ID
- LGIOG-2017-01
- Conditions
- Colonic Neoplasms, Drug Therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- China Medical University, ChinaUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 1 Oct 2021 (estimated)
- Study completion
- 1 Oct 2021 (estimated)
- First posted
- 30 Mar 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.
To evaluate the efficacy and safety of neoadjuvant FOLFOXIRI chemotherapy (irinotecan, oxaliplatin and fluorouracil) in the patients with locally advanced colon cancer.
Detailed description
For the patients with locally advanced colon cancer, adjuvant FOLFOX and XELOX chemotherapy have become standard treatment. However, 30% - 40% patients suffered from local recurrence or distant metastasis after this standard treatment. Neoadjuvant chemotherapy could shrink tumors, eliminate micrometastasis, reduce surgical trauma and accelerate recovery. Hence, we evaluate the efficacy and safety of FOLFOXIRI as neoadjuvant chemotherapy in treating patients with locally advanced colon cancer.
In this prospective study, 30 patients with locally advanced colon cancer will be treated with 4 cycles of neoadjuvant FOLFOXIRI chemotherapy followed by surgical resection. PET-CT scanning will be performed before and after the neoadjuvant FOLFOXIRI chemotherapy to assess SUVmax changes. The ctDNA in peripheral blood before and after each cycle of neoadjuvant FOLFOXIRI chemotherapy will be detected. In the course of treatment, safety evaluation will be carried out according to adverse reaction classification (CTCAE) 4. 0.
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: FOLFOXIRIPatients received 4 cycles of neoadjuvant FOLFOXIRI chemotherapy before surgical resection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age: 18-75years old
- Primary and pathological diagnosis of colon adenocarcinoma
- Radiographic evaluation of initial resectable colon cancer
- T4b colon cancer
- ECOG status: 0～1
Key exclusion criteria (17 listed)
- Previous treatment with oxaliplatin, irinotecan or fluorouracil
- Hypersensitivity to fluorouracil, oxaliplatin or irinotecan.
- With distant metastasis
- Cardiovascular disease that would preclude study treatment or follow-up; New York Heart Association class III or IV heart disease; active ischemic heart disease; myocardial infarction within the past 6 months; symptomatic arrhythmia uncontrolled hypertension. Unexplained syncope occurred within 3 months
- Digestive system diseases that would preclude study treatment or follow-up within the past 6 months
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 |
|---|---|---|
| FOLFOXIRIAlso: Irinotecan, Oxaliplatin, 5-FluorouracilIrinotecan 150 mg/m^2 IV over 1h, day 1 + Oxaliplatin 85 mg/m^2 IV over 2h, day 1 + L-Leucovorin 200 mg/m^2 IV over 2h, day 1 + 5-Fluorouracil 2800 mg/m^2 IV 48h continuous infusion, starting on day 1 administered every two weeks for 4 cycles (2 months) | Drug | FOLFOXIRI |
Primary outcome
The ratio of tumor downstaging to stage 0 and stage I
Time frame: 2 years
Tumor downstaging from stage II or III to pathologic complete response (stage 0) and stage I
7 secondary outcomes
Tumor regression grade (TRG)
Time frame: 2 years
Disease free survival
Time frame: 3 years
Overall survival time
Time frame: 3 years
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: 3 years
ctDNA change
Time frame: 3 years
SUVmax changes
Time frame: At the begin of Cycle 1 and the end of Cycle 4 (each cycle is 14 days)
Quality of life (QLQ C30)
Time frame: Every 2 weeks after the first treatment until 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 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.
Jingdong Zhang study chair
Cancer Hospital of China Medical University, Department of Medical Oncology, Liaoning 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 FOLFOXIRI in people with Colonic Neoplasms and Drug Therapy, run by China Medical University, China 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 17 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 19 Apr 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 Jingdong Zhang (+86-13804027878, zhangjingdong@cancerhosp-ln-cmu.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The ratio of tumor downstaging to stage 0 and stage I (time frame: 2 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 19 Apr 2021.