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Rectal CancerPhase 2NCT03997435

FOLFOXIRI With or Without Intensification for Rectal Cancer

A Phase 2 study testing Experimental arm in people with Rectal Cancer, run by CCTU at 3 sites in Hong Kong.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

Pathologic complete response rate Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Rectal Cancer
What is being tested?
Experimental arm
Could I receive a placebo?
No, everyone receives an active treatment
How many people
72 participants
Where
3 sitesHong Kong
Study dates
10 Sep 2019to 31 Dec 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

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

  • Able to provide written informed consent
  • Age >= 18 years of either sex.
  • ECOG performance status 0-1
  • Measurable disease by RECIST 1.1 criteria.
  • Histologically confirmed rectal adenocarcinoma (defined as either mid- or low rectal cancer that is located within 12 cm from the anal verge OR below the peritoneal reflection) that is previously untreated.
  • 'High risk' rectal cancer, or rectal cancers that are considered marginally perable where there is a significant risk of positive surgical margin:
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  • T3 or T4, and / or
  • Tumour infiltrating perirectal fat and/ or mesorectal fascia, and / or Involvement of pelvic lymph nodes, and/or
  • Tumour invading surrounding structures or peritoneum or vasculature.
  • Adequate bone marrow, renal and hepatic function as defined by: absolute neutrophil count >= 1.5 x 109/L, hemoglobin >= 9 g/L, platelets >= 100 x 109/L, serum creatinine level < 1.5 x ULN (or calculated creatinine clearance >=50 ml/min, whichever is worse), total bilirubin <=1.5 x the upper limit of normal, alanine aminotransferase (ALT) < 3 upper limit of normal.

Who cannot join

  • Known distant metastasis, even if the metastasis has been resected.
  • History of another invasive malignancy within the last 5 years, except for treated basal cell carcinoma of the skin, cervical intraepithelial neoplasia, or breast DCIS.
  • Upper rectal cancer that is located above the peritoneal reflection.
  • Patients with synchronous colon and rectal cancers are not excluded as long as: (1) these tumors are considered as two separate primaries (i.e. not metastasis or a contiguous part of a large primary), (2) both tumors are not causing imminent obstruction; (3) pelvic radiotherapy is not considered a contraindication.
  • Primary tumour associated with any one of the following features:Frank intestinal obstruction, or
  • Endoscope unable to pass through the tumour's lumen plus worsening local obstructive symptoms. Note: Patients with such features should be assessed by the surgical team regarding stomal bypass prior to study enrolment. Such patients can still be considered for study enrolment after undergoing stomal bypass.
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  • Known hypersensitivity reaction to the study drugs (i.e. fluoropyrimidine, irinotecan, oxaliplatin)
  • Known peripheral neuropathy of grade 2 or more in severity.\ -Patients who have received an experimental anticancer therapy within the last 28 days.
  • Previous pelvic radiotherapy
  • Previous oxaliplatin or irinotecan for the treatment of colon or rectal cancer.
  • Patient with hip prosthesis
  • Major surgery (i.e. requiring general anaesthetics) within the last 28 days. Exception: Any patient who underwent stomal bypass for obstructing primary tumour within the last 14 days are still eligible, as long as the patient has sufficiently recovered from the surgery at the investigator's discretion.
  • Known cardiac disease that is symptomatic or poorly controlled, including cardiac failure, arrhythmia or ischemic heart disease.
  • Myocardial infarction or cerebrovascular accident within the last 12 months.
  • Intercurrent infections or medical illnesses that are serious/ potentially life-threatening and require ongoing treatment.
  • Patients who are unable to take capecitabine tablets uncrushed by the oral route (e.g. enteral feeding). Patients with significantly impaired gastrointestinal integrity and absorption are excluded.
  • Patients with known and untreated bilateral hydronephrosis and/or hydroureters (or unilateral hydronephrosis and/or hydroureters in any patient with a single kidney) are excluded. The obstruction should be treated with ureteric stent(s) or percutaneous nephrostomy(s) prior to study enrolment. Patients with unilateral hydronephrosis and/or hydroureters and adequate renal function (i.e. as stated in the eligibility criteria: serum creatinine level < 1.5 x ULN, or calculated creatinine clearance >=50 ml/min - whichever is worse) are not excluded.
  • Patients on warfarin therapy. Patients on low molecular weight heparin are not excluded.
  • Pregnant or lactating women.
  • Patients with reproductive potential who are not willing to use barrier method of birth control.
  • Patients who are unable to provide written informed consent, or to comply with study requirements as judged by the investigator.
  • Patients who refuse surgical treatment of the rectal cancer.

Trial locations and contacts

3 sites in 1 country.

Hong Kong3 sites

  • Department of Clinical Oncology, Queen Mary Hospital

    Hong Kong

  • Department of Oncology, Princess Margaret Hospital

    Hong Kong

  • The Chinese University of Hong Kong

    Hong Kong

Other trials in Hong Kong

About this study

Official title: A Randomized Study of Neoadjuvant Chemoradiotherapy With or Without Intensification With the FOLFOXIRI Chemo-regimen for High-risk Locally Advanced Rectal Cancer

Pathologic complete response rate

Conditions
Rectal Cancer
Being tested
Control arm, Experimental arm
Medical subject headings
Rectal Neoplasms

What participants receive

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

  • Control armDrug

    neoadjuvant concurrent capecitabine-radiotherapy followed by surgery and postoperative chemotherapy.

  • Experimental armDrug

    Neoadjuvant FOLFOXIRI x4 cycles, then capecitabine-radiotherapy and postoperative chemotherapy.

Study groups in NCT03997435
Study groupRoleWhat they receive
Control armExperimentalneoadjuvant concurrent capecitabine-radiotherapy followed by surgery and postoperative chemotherapy
Receives: Drug: Control arm
Experimental armExperimentalNeoadjuvant FOLFOXIRI x4 cycles, then capecitabine-radiotherapy and postoperative chemotherapy
Receives: Drug: Experimental arm

What is being measured

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

  1. Rate of pathologic complete response

    Measured: 2 years

Secondary outcomes (11)

  1. Rate of tumour regression grade

    Measured: 2 years

  2. Number of objective tumour response

    Measured: 2 years

  3. Rate of circumferential resection margin (CRM) clearance

    Measured: 2 years

  4. Rate of tumour downstaging

    Measured: 2 years

  5. Number of Participants with Adverse Events

    Measured: 2 years

  6. Rate of overall survival

    Measured: 5 years

  7. Rate of disease-free survival, relapse-free survival

    Measured: 5 years

  8. Time to local (and distant) recurrence

    Measured: 5 years

  9. Number of patients with 30-days post-operative mortality

    Measured: 1 month

  10. Rate of compliance to study treatment

    Measured: 2 years

  11. Number of response to neoadjuvant therapy

    Measured: 2 years

Timeline

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

  1. First posted25 Jun 2019
  2. Study start10 Sep 2019
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2027 (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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
72 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03997435
Sponsor's protocol ID
COL026
Status last verified
Nov 2025
First submitted
19 Jun 2019
Last updated
17 Nov 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Experimental arm in people with Rectal Cancer, run by CCTU at 3 sites in Hong Kong.

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 10 inclusion and 22 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: under way, not looking for participants, as of the sponsor's last update on 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Hong Kong. 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?

This study is still under way. Results are not available in the source record yet.

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?

Rate of pathologic complete response (time frame: 2 years). 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 NCT03997435.

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 17 Nov 2025.

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