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High-risk Locally Advanced Colorectal CancerPhase 2NCT05018182

FOLFOXIRI for Neoadjuvant Treatment of High-risk Locally Advanced Colorectal Cancer

A Phase 2 study testing Oxaliplatin, Irinotecan and Folinic Acid in people with High-risk Locally Advanced Colorectal Cancer and Neoadjuvant Chemotherapy, run by West China Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

The main cause of recurrence after surgical treatment of colorectal cancer is distant metastasis. Neoadjuvant chemotherapy has potential benefits of improving the effectiveness of chemotherapy. Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
Oxaliplatin, Irinotecan and Folinic Acid
Could I receive a placebo?
No, everyone receives an active treatment
How many people
69 participants
Where
1 siteChina
Study dates
2 Aug 2021to 2 Aug 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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age: 18-75 years old; Sex: Male or female;
  • WHO performance status of 0, 1 or 2
  • Histologically proven colorectal carcinoma (defined as cancer that is located >10 cm from the anal verge by endoscopy)
  • Unequivocal radiological evidence of locally advanced cancer based on thin slice spiral CT [defined as T4a/b or (and) N2 / fused lymph nodes or (and) positive extramural vascular invasion (EMVI +) or (and) circumferential resection margin (CRM) ≤ 2mm].
  • No distant metastases (distant organ or (and) distant lymph node metastases) assessed by CT scan or other radiographic examination.
  • For patients with T4b, R0 resection was expected to be achieved, including the necessary combined organ resection，by MDT discussion.
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  • No history of 5-Fu and platinum drug allergy.
  • Adequate bone marrow function: Hb>9g/dl; PLT >100 x 10^9/l; WBC >3.5 x 10^9/l and ANC ≥1.5x10^9/l.
  • Adequate hepatobiliary function: ASAT (aspartate aminotransferase) and ALAT (alanine aminotransferase) of 2.5 x ULN (upper limits of normal) or less, Alkaline phosphatase of 2.5 x ULN or less, total bilirubin 1.5 x upper normal level or less.
  • Adequate renal biochemistry: GFR >50 ml/min calculated by the Wright or Cockroft formula or EDTA clearance >70 ml/min.
  • For female and of childbearing potential, patient must have a negative pregnancy test ≤72hours prior to initiating study treatment and agree to avoid pregnancy during and for 6 months after study treatment. For male with a partner of childbearing potential, patient must agree to use adequate, medically approved, contraceptive precautions during and for 90 days after the last dose of study treatment
  • Patient able and willing to provide written informed consent for the study.

Who cannot join

  • Patients with lynch syndrome
  • Rectal cancer located 10 cm or less from the anal verge.
  • Any patient for whom radiotherapy is advised by the MDT.
  • Patient with evidence of distant metastases or peritoneal nodules (M1).
  • Severe intestinal complications on initial clinical or imaging assessment: perforation, obstruction, uncontrollable bleeding.
  • Another serious medical condition judged to compromise ability to tolerate neoadjuvant therapy and/or surgery.
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  • Pre-existing or concurrent other malignancies (including concurrent colon cancer), except for cured basal cell carcinoma of the skin and carcinoma in situ of the cervix.
  • Pregnant or breastfeeding women.
  • Patients with severe cardiovascular disease and diabetes mellitus that cannot be easily controlled.
  • Persons with mental disorders.
  • Patients with severe infections.
  • Patients on thrombolytic/anticoagulant therapy, bleeding quality or coagulation disorders; or aneurysms, strokes, transient ischemic attacks, arteriovenous malformations in the past year.
  • Previous history of renal disease with urine protein on urinalysis or clinically significant renal function abnormalities.

Trial locations and contacts

1 site in 1 country.

Meng Qiu, Ph.D contact

+8602885423203

qiumeng@wchscu.cn

Weibing Leng, Ph.D contact

+8602885423203

s103470@stu.scu.edu.cn

China1 site, 1 recruiting

  • Sichuan University West China Hospital

    Chengdu, Sichuan, 610044

    Weibing Leng, 18980601776, s103470@stu.scu.edu.cn

    Recruiting

Other trials in China

About this study

Official title: To Observe the Pathological Remission Rate and Safety of FOLFOXIRI for Neoadjuvant Treatment of High-risk Locally Advanced Colorectal Cancer With a Single-arm, Open, Prospective Phase II Exploratory Clinical Study

The main cause of recurrence after surgical treatment of colorectal cancer is distant metastasis. Neoadjuvant chemotherapy has potential benefits of improving the effectiveness of chemotherapy. Preoperative chemotherapy may eradicate microscopic metastatic cancer cells earlier than adjuvant chemotherapy, reduce cancer cell spillage during surgery, and lessen the invasiveness of surgical resection. The FOLFOXIRI regimen has been shown to have a high objective efficiency in advanced colorectal cancer. This phase II trial is to explore the pathological remission rate and safety of stage II/III locally advanced colon cancer with high risk of recurrence to FOLFOXIRI regimen of neoadjuvant chemotherapy alone.

Being tested
Oxaliplatin, Irinotecan, Folinic Acid, 5FU, Capecitabine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OxaliplatinDrug

    Also called Eloxatin

    Oxaliplatin 85 mg/m² Q2w(2 h) before surgery rection and 130 mg/m² Q3w (2 h) after surgery

  • IrinotecanDrug

    Also called Campto

    Irinotecan 150 mg/m² ivgtt(1.5 h) Q2w before surgery rection

  • Folinic AcidDrug

    Also called Leukovorin

    Folinic acid 400 mg/m² ivgtt(2 h) Q2w before surgery rection

  • 5FUDrug

    Also called 5-Fluorouracil

    5-FU 2800 mg/m² civ(46 h) Q2w before surgery rection

  • CapecitabineDrug

    Also called Xeloda

    Capecitabine 1000mg/m² d1-14 po Q3w after surgery rection

Study groups in NCT05018182
Study groupRoleWhat they receive
Neoadjuvant chemotherapyExperimental4 cycles of neoadjuvant chemotherapy with FOLFOXIRI + operation + 5 cycles of adjuvant chemotherapy with XELOX
Receives: Drug: Oxaliplatin; Drug: Irinotecan; Drug: Folinic Acid; Drug: 5FU; Drug: Capecitabine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pathological response

    The rate of Tumor Regression Grade 0-1 in the resected tumour tissue

    Measured: up to 24 weeks

Secondary outcomes (10)

  1. Objective Response Rate (ORR)

    Rate of patients with partial or complete response according to modified RECIST criteria.

    Measured: up to 24 weeks

  2. Pathologic Complete Response (PCR)

    Rate of pathological complete response in the resected tumour tissue

    Measured: up to 24 weeks

  3. R0 resection rate

    Resection rate, defined as patients with microscopically complete (R0) resection (ITT- population)

    Measured: up to 24 weeks

  4. Progression Free Survival (PFS)

    Progression free survival (Medium, Kaplan-Meier-estimation, ITT- population)

    Measured: up to 3 years

  5. Distant metastasis-free survival Metastasis-free survival

    distant Distant metastasis-free survival (Medium, Kaplan-Meier-estimation, ITT- population)

    Measured: up to 3 years

  6. Overall survival

    Overall survival (Kaplan-Meier-estimation, ITT- population)

    Measured: up to 3 years

  7. Toxicity and Compliance to study treatment

    Toxicity according to NCI-CTC criteria v. 4.0 Perioperative toxicity according to Clavien

    Measured: up to 1 years

  8. Molecular markers

    Evaluation of molecular predictive markers for response and toxicity

    Measured: up to 1 years

  9. Quality of Life to study treatment

    scores of Quality of Life Questionare-Core 30 of the European Organization for Research and Treatment of Cancer

    Measured: up to 1 years

  10. Number of patients with 30-day post-operative mortality

    Measured: up to 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Aug 2021
  2. Study start2 Aug 2021
  3. Primary completionApr 2022 (estimated)
  4. Study completion2 Aug 2022 (estimated)

Resources

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
69 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05018182
Sponsor's protocol ID
2021-010
Status last verified
Aug 2021
First submitted
3 Aug 2021
Last updated
24 Aug 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Chen X, Leng W, Zhou Y, Yu Y, Meng W, Cao P, Wang Z, Qiu M. Pathological response and safety of FOLFOXIRI for neoadjuvant treatment of high-risk relapsed locally advanced colon cancer: study protocol for a single-arm, open-label phase II trial. BMJ Open. 2023 Jan 31;13(1):e062659. doi: 10.1136/bmjopen-2022-062659.

    PubMed 36720570

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Oxaliplatin, Irinotecan and Folinic Acid in people with High-risk Locally Advanced Colorectal Cancer and Neoadjuvant Chemotherapy, run by West China Hospital 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 12 inclusion and 13 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 24 Aug 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 Meng Qiu, Ph.D (+8602885423203, qiumeng@wchscu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pathological response (time frame: up to 24 weeks). 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 NCT05018182, 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 24 Aug 2021.

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