NCT06205485 · Canadian Cancer Trials Group
Neoadjuvant Chemotherapy, Excision And Observation vs Chemoradiotherapy For Rectal Cancer
(NEO-RT)
What this study is about
This study is being done to answer the following questions: Is the chance of rectal cancer responding the same if chemotherapy alone is given before limited surgery compared to chemotherapy and radiation therapy given together before limited surgery? If radiation therapy is not given, is quality of life better?
View original scientific description
This study is being done to answer the following questions: Is the chance of rectal cancer responding the same if chemotherapy alone is given before limited surgery compared to chemotherapy and radiation therapy given together before limited surgery? If radiation therapy is not given, is quality of life better?
Interventions
DRUG
Leucovorin
400 mg/m2
DRUG
Oxaliplatin
85 mg/m2 or 130 mg/m2 on day 1
DRUG
Fluoruracil
bolus fluoruracil (optional) 400 mg, infusional fluorouracil 2,400 mg/m2
DRUG
Capecitabine
1,000 mg/m2 twice daily for 14 days
RADIATION
Radiation
54 Gy (27-30 fractions)
Primary outcome measures
Clinical response rate upon re-staging
Time frame: 6 years
Quality of Life defined using the LARS score
Time frame: 6 years
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Histologically confirmed invasive, well-moderately differentiated rectal adenocarcinoma, mismatch repair proficient.
- MRI stage cT1 not eligible for transanal surgery or cT2-T3a.
- cN0 stage based on pelvic MRI - including absence of radiographic evidence of mesorectal nodal metastasis, tumour deposits or extramural venous invasion (EMVI).
- M0 stage based on no evidence of metastatic disease by CT imaging of chest, abdomen and pelvis.
- Mid to low-lying tumour eligible for transanal excision in the opinion of the treating surgeon.
- Medically fit to undergo radical TME surgery as per treating surgeon's decision.
- Participant is able (i.e. sufficiently fluent) and willing to complete the quality of life questionnaires in either English or French or Spanish.
- Age of at least 18 years.
- No contraindications to protocol chemotherapy.
- Adequate normal organ and marrow function: ANC ≥ x 10\^9/L; platelet count ≥ 100 x 10\^9/L; bilirubin \< 1.5 UNL, excluding Gilb
Where
- Phoenix, Arizona
- Irvine, California
- Los Angeles, California
- Orange, California
- Santa Maria, California
- Millville, Delaware
- Newark, Delaware
- Rehoboth Beach, Delaware
- Orlando, Florida
- Atlanta, Georgia
- Aurora, Illinois
- Chicago, Illinois
And 77 more locations — see the full list below.
Collaborators
Alliance for Clinical Trials in Oncology, ECOG-ACRIN Cancer Research Group, NRG Oncology, SWOG Cancer Research Network
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 14, 2026 · Source of record for eligibility and locations