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Rectal CancerPhase 2NCT03259035

NEO: Neoadjuvant Chemotherapy, Excision and Observation for Early Rectal Cancer

A Phase 2 study testing Folfox Protocol and Capox in people with Rectal Cancer, run by Canadian Cancer Trials Group at 11 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to find out the effects of chemotherapy followed by less invasive surgery on patients and their early rectal cancer. The approach of this trial will be considered a success if at least 65% of participants are able to keep the rectum. 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?
Folfox Protocol and Capox
Could I receive a placebo?
No, everyone receives an active treatment
How many people
58 participants
Where
11 sitesin 2 countries
Study dates
29 Jun 2018to 25 Apr 2024
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Histologically confirmed invasive well-moderately differentiated rectal adenocarcinoma diagnosed within 90 days prior to enrollment.
  • Tumour stage cT1-T3abN0 based on pelvic MRI
  • cT1N0- tumour invasion into submucosa, no radiographic evidence of mesorectal nodal metastasis, tumour deposits or vascular invasion.
  • cT2N0 - tumour invasion into muscularis propria, no radiographic evidence of mesorectal nodal metastasis, tumour deposits or vascular invasion.
  • cT3a,bN0- tumour invasion through the muscularis propria no more than 5 mm into the subserosa/perirectal tissue and clear of the circumferential radial margin (CRM). Absence of radiographic evidence of mesorectal nodal metastasis, tumour deposits or lymphovascular invasion.
  • Note: If the tumour is not visualized in the MRI but there is histological confirmation of rectal adenocarcinoma the patient is eligible.
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  • cN0 stage based on pelvic MRI. Any nodes ≥ 10 mm in longest dimension are considered malignant, regardless of nodal morphology. For pelvic nodes < 10 mm in longest dimension, if nodes are seen and are deemed to be morphologically benign in the opinion of the radiologist and surgeon, the patient is eligible. Patients with visible pelvic sidewall nodes are excluded
  • M0 stage based on no evidence of metastatic disease by CT imaging.
  • Mid to low-lying tumour eligible for local tumour excision in the opinion of the treating surgeon.
  • Age of at least 18 years.
  • Medically fit to undergo radical surgery as per treating surgeon's discretion
  • No contraindications to protocol chemotherapy.
  • Adequate normal organ and marrow function as defined below (must be done within 30 days prior to enrolment):
  • ANC ≥ 1.5 x 109/L
  • platelet count ≥100 x 109/L
  • bilirubin < 1.5 ULN, excluding Gilbert's syndrome
  • Calculated creatinine clearance of ≥ 50 ml/min.
  • Clearance to be calculated using Cockcroft formula: Males: 1.23 x (140 - age) x weight (kg) - serum creatinine (μmol/l) ; Females: 1.05 x (140 - age) x weight (kg) - serum creatinine (μmol/l)
  • The patient must have an ECOG performance status of 0, 1.
  • Patient is able (i.e. sufficiently fluent) and willing to complete the quality of life and health utility questionnaires.
  • Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each patient must sign a consent form prior to enrollment in the trial to document their willingness to participate.
  • Must be accessible for treatment and follow up. Patients registered on this trial must be treated with chemotherapy and followed at the enrolling centre.
  • Protocol treatment is to begin within 5 working days of patient enrollment.
  • Women/men of childbearing potential must have agreed to use a highly effective contraceptive method during and for 6 months after completion of chemotherapy.

Who cannot join

  • Patient has pathologic high risk factors on either the initial biopsy specimen report or follow-up biopsy (if done): high histologic grade, mucinous histology, lymphatic or vascular invasion.
  • History of other malignancies, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for ≥ 5 years.
  • Synchronous cancer.
  • Prior treatment for rectal cancer.
  • Previous pelvic radiation for any reason.
  • Patients with known dihydropyrimidine dehydrogenase deficiency
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  • Treatment with other investigational drugs or anti-cancer therapy within 28 days prior to enrolment.
  • Clinically significant (i.e. active) cardiovascular disease for example cerebro vascular accidents (< 6 months prior to enrolment), myocardial infarction (< 6 months prior to enrolment), unstable angina, New York Heart Association (NYHA) grade II or higher, congestive heart failure, serious cardiac arrhythmia requiring medication.
  • Any contra-indications to undergo MRI imaging.

Trial locations and contacts

11 sites in 2 countries.

11 sites in 2 countries

Canada8 sites

  • Health Sciences North

    Greater Sudbury, Ontario, P3E 5J1

  • QEII Health Sciences Centre

    Halifax, Nova Scotia, B3H 1V7

  • Kingston Health Sciences Centre

    Kingston, Ontario, K7L 2V7

  • The Research Institute of the McGill University

    Montreal, Quebec, H4A 3J1

  • Ottawa Hospital Research Institute

    Ottawa, Ontario, K1H 8L6

  • BCCA - Vancouver Cancer Centre

    Vancouver, British Columbia, V5Z 4E6

  • St. Paul's Hospital

    Vancouver, British Columbia, V6Z 1Y6

  • CancerCare Manitoba

    Winnipeg, Manitoba, R3E 0V9

Other trials in Canada

United States3 sites

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02115

  • UC Irvine Medical Center

    Orange, California, 92868

  • Virginia Mason Medical Center

    Seattle, Washington, 97101

Other trials in United States

About this study

The purpose of this study is to find out the effects of chemotherapy followed by less invasive surgery on patients and their early rectal cancer. The approach of this trial will be considered a success if at least 65% of participants are able to keep the rectum.

Conditions
Rectal Cancer
Being tested
Folfox Protocol, Capox
Medical subject headings
Rectal Neoplasms

What participants receive

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

  • Folfox ProtocolDrug

    6 cycles of q2weekly FOLFOX, or

  • CapoxDrug

    4 cycles of q3weekly CAPOX

Study groups in NCT03259035
Study groupRoleWhat they receive
chemotherapy (FOLFOX or CAPOX) followed by tumour excisionExperimentalNot described
Receives: Drug: Folfox Protocol; Drug: Capox

What is being measured

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

  1. Percentage of Organ Preservation

    Defined as the percentage of patients with tumour downstaging to ypT0/T1good N0 and who avoid radical surgery.

    Measured: 3 years

Secondary outcomes (4)

  1. Percentage of Locoregional Relapses at 3 Years

    Locoregional relapse is defined as reappearance of a tumour within the rectum or pelvis. The percentage of loco-reginal relapse at 3 years was estimated by Kaplan-Meier method for the survival function of the loco-regional relapse free survival, defined as the time from enrollment to the first date of definitive evidence (clinical, radiological or pathological) of locoregional relapses with patients who developed distant relapse only, died, loss to follow up, or were alive at clinical cut-off censored at respectively at last date of distant relapses, date of death, date of lost to follow-up, or last disease assessment date.

    Measured: 3 years

  2. Percentage of Distant Relapse at 3 Years

    Distant relapse is defined as appearance of rectal cancer disease at sites remote from the rectum. The percentage of distant relapse at 3 years was estimated also by Kaplan-Meier method for the survival function of the distant free survival, defined as the time from enrollment to the first date of definitive evidence (clinical, radiological or pathological) of distant relapses with patients who died, loss to follow up, or were alive at clinical cut-off censored at respectively: date of death, date of lost to follow-up, and last disease assessment date.

    Measured: 3 years

  3. Percentage of Disease Free at 3 Years

    Percentage of disease free at 3 years was estimated by Kaplan-Meier method for the survival function of Disease-Free Survival (DFS), which is defined as the interval from date of enrollment to the first date of the events defined below:

    • Locoregional relapse
    • Distant relapse
    • Non-protocol radiotherapy, chemotherapy, or biologic therapy without documentation of the site of failure
    • Death due to any other reason. Patients who were alive without locoregional or distant relapse or receiving non-protocol radiotherapy, chemotherapy, or biologic therapy without documentation of the site of failure at the clinical data cutoff date were censored at their last disease assessment date. 3 year disease free survival was estimated by Kaplan-Meier method.

    Measured: 3 years

  4. Rate of Intraoperative Complications

    Percentage of patients with at least one intraoperative injury

    Measured: 1 day

Timeline

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

  1. First posted23 Aug 2017
  2. Study start29 Jun 2018
  3. Primary completion8 Apr 2024
  4. Study completion25 Apr 2024

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
Model description
This is a two staged, single arm phase II trial of chemotherapy (FOLFOX or CAPOX) followed by tumour excision in patients with early stage rectal cancer
Masking
None (open label)
Enrolment
58 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03259035
Sponsor's protocol ID
CO28
Status last verified
Oct 2024
First submitted
21 Aug 2017
Last updated
9 Apr 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Kennecke HF, O'Callaghan CJ, Loree JM, Moloo H, Auer R, Jonker DJ, Raval M, Musselman R, Ma G, Caycedo-Marulanda A, Simianu VV, Patel S, Pitre LD, Helewa R, Gordon VL, Neumann K, Nimeiri H, Sherry M, Tu D, Brown CJ. Neoadjuvant Chemotherapy, Excision, and Observation for Early Rectal Cancer: The Phase II NEO Trial (CCTG CO.28) Primary End Point Results. J Clin Oncol. 2023 Jan 10;41(2):233-242. doi: 10.1200/JCO.22.00184. Epub 2022 Aug 18.

    PubMed 35981270

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Folfox Protocol and Capox in people with Rectal Cancer, run by Canadian Cancer Trials Group at 11 sites in 2 countries.

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 24 inclusion and 9 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 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in Canada, United States. 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?

Yes. Results are posted in the registry (first posted 10 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percentage of Organ Preservation (time frame: 3 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 NCT03259035, 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 9 Apr 2026.

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