Rectal CancerPhase 2NCT01941641
Colon Neoadjuvant FOLFOXIRI Study
A Phase 2 study testing neoadjuvant FOLFOXIRI and Capecitabine in people with Rectal Cancer, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
Objective tumour response rate to FOLFOXIRI to pre-operative therapy. 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?
- neoadjuvant FOLFOXIRI and Capecitabine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteHong Kong
- Study dates
- 9 Oct 2013to 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
- 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 operable where there is a significant risk of positive surgical margin:
- T3 (low-lying tumour at or below the levators) or T4, or
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- Tumour infiltrating perirectal fat, or
- Any T-stage (T1-4) and node-positive tumour (invading surrounding structures or peritoneum)
- 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, calculated creatinine clearance >= 55 ml/min, total bilirubin =<1.5 x the upper limit of normal, alanine aminotransferase (ALT) =<2.5 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 non-invasive DCIS of the breast.
- Upper rectal cancer that is located above the peritoneal reflection.
- 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 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II Study of Neoadjuvant FOLFOXIRI Followed by Concurrent Capecitabine and Radiotherapy for High Risk Rectal Cancer
Objective tumour response rate to FOLFOXIRI to pre-operative therapy.
- Conditions
- Rectal Cancer
- Being tested
- neoadjuvant FOLFOXIRI, Capecitabine
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neoadjuvant FOLFOXIRIDrug
CapecitabineDrug
| Study group | Role | What they receive |
|---|---|---|
| neoadjuvant FOLFOXIRI | Experimental | Not described Receives: Drug: neoadjuvant FOLFOXIRI; Drug: Capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective tumour response rate
Measured: 2 years
Secondary outcomes (11)
Tumour regression grade
Measured: 2 years
pathologic complete response
Measured: 2 years
Rate of circumferential resection margin (CRM) clearance
Measured: 2 years
Rate of tumour downstaging
Measured: 2 years
Number of Participants with Adverse Events
Measured: 2 years
Overall survival
Measured: 5 years
disease-free survival, relapse-free survival
Measured: 5 years
Time to local (and distant) recurrence
Measured: 5 years
Number of patients with 30-day post-operative mortality
Measured: 1 month
Compliance to study treatment
Measured: 2 years
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.
- First posted13 Sep 2013 (estimated)
- Study start9 Oct 2013
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
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 Rectal CancerStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, CCTU, Chinese University of Hong Kong
- Investigators
- Brigette MA, MD, FRCP, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01941641
- Sponsor's protocol ID
- COL021
- Status last verified
- Nov 2025
- First submitted
- 3 Sep 2013
- Last updated
- 17 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Lui RN, Chu S, Ng DCK, Li L, Cho CCM, Hung EHY, Wong KH, Mo FKF, Wong ECH, Hui CWC, Lam DCM, Suen J, Kang W, Ho WM, Futaba K, Hon SSF, Yan K, Ng SSM, Ma BBY. Multicenter phase II study of neoadjuvant FOLFOXIRI followed by concurrent chemoradiotherapy in Chinese patients with high-risk rectal cancer. Oncologist. 2026 May 8;31(6):oyag162. doi: 10.1093/oncolo/oyag162.
PubMed 42050144
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Neoadjuvant FOLFOXIRI Followed by Concurrent Capecitabine and Radiotherapy for High Risk Rectal Cancer
- ClinicalTrials.gov ID
- NCT01941641
- Acronym / sponsor ID
- COL021
- Conditions
- Rectal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 9 Oct 2013 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 13 Sep 2013 (estimated)
- 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.
Objective tumour response rate to FOLFOXIRI to pre-operative therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| neoadjuvant FOLFOXIRI | Experimental | Drug: neoadjuvant FOLFOXIRI, Drug: Capecitabine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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 operable where there is a significant risk of positive surgical margin:
Key exclusion criteria (12 listed)
- 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 non-invasive DCIS of the breast.
- Upper rectal cancer that is located above the peritoneal reflection.
- Primary tumour associated with any one of the following features:
- Known hypersensitivity reaction to the study drugs (i.e. fluoropyrimidine, irinotecan, oxaliplatin)
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 |
|---|---|---|
| neoadjuvant FOLFOXIRI | Drug | neoadjuvant FOLFOXIRI |
| Capecitabine | Drug | neoadjuvant FOLFOXIRI |
Primary outcome
Objective tumour response rate
Time frame: 2 years
11 secondary outcomes
Tumour regression grade
Time frame: 2 years
pathologic complete response
Time frame: 2 years
Rate of circumferential resection margin (CRM) clearance
Time frame: 2 years
Rate of tumour downstaging
Time frame: 2 years
Number of Participants with Adverse Events
Time frame: 2 years
Overall survival
Time frame: 5 years
disease-free survival, relapse-free survival
Time frame: 5 years
Time to local (and distant) recurrence
Time frame: 5 years
Number of patients with 30-day post-operative mortality
Time frame: 1 month
Compliance to study treatment
Time frame: 2 years
Number of response to neoadjuvant therapy
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2025.
- Derived from this study: PubMed 42050144Lui RN, Chu S, Ng DCK, Li L, Cho CCM, Hung EHY, Wong KH, Mo FKF, Wong ECH, Hui CWC, Lam DCM, Suen J, Kang W, Ho WM, Futaba K, Hon SSF, Yan K, Ng SSM, Ma BBY. Multicenter phase II study of neoadjuvant FOLFOXIRI followed by concurrent chemoradiotherapy in Chinese patients with high-risk rectal cancer. Oncologist. 2026 May 8;31(6):oyag162. doi: 10.1093/oncolo/oyag162.
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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.
Brigette MA, MD, FRCP principal investigator
Chinese University of Hong Kong
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 neoadjuvant FOLFOXIRI and Capecitabine in people with Rectal Cancer, run by Chinese University of Hong Kong at 1 site 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 9 inclusion and 12 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 1 site 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?
Objective tumour response rate (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 NCT01941641, 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 17 Nov 2025.