Trial comparing treatments for Rectal Cancer
Official title Neoadjuvant Chemotherapy, Excision And Observation vs Chemoradiotherapy For Rectal Cancer
ClinicalTrials.gov ID: NCT06205485
What this study is testing
What is Leucovorin?
Leucovorin is an investigational drug being studied as part of treatment for rectal cancer. Leucovorin is designed to enhance the activity of certain chemotherapy agents by stabilizing their binding to thymidylate synthase.
Also referred to as folinic acid.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to see whether giving only chemotherapy before limited surgery gives the same chance of tumor response as giving chemotherapy with radiation together. It also asks if patients have a better quality of life when radiation is not used.
- Who it's for
- Adults with rectal cancer who are candidates for limited surgery.
- What's involved
- Participants will receive either chemotherapy alone or chemotherapy plus radiation before surgery, then have the surgery and be followed up. They will have regular visits and tests to monitor the cancer and health.
- Time commitment
- The study lasts about 6–12 months, with several clinic visits for treatment, surgery, and follow‑up assessments.
- Phase 3: a large, late-stage study
- Time commitment: about 5 years
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Histologically confirmed invasive, well-moderately differentiated rectal adenocarcinoma, mismatch repair proficient.
- MRI stage cT1 not eligible for transanal surgery or cT2-T3ab\ . \ T3a: \<1mm depth invasion, T3b: 1-5mm depth of invasion.
- cN0 stage based on pelvic MRI - including absence of radiographic evidence of mesorectal nodal metastasis, tumour deposits or extramural venous...
- 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.
You likely can't join if
- Pathologic high-risk factors on diagnostic biopsy: high histologic grade (poorly differentiated), mucinous or signet ring histology.
- Patients with visible pelvic sidewall nodes on MRI.
- Patients with unequivocal determination of nodal disease that, in the opinion of the investigator, would prohibit protocol therapy administration.
- Previous pelvic radiation for any reason, including brachytherapy alone.
- Patients who have had primary lesion excised prior to enrollment. If a patient has had partial excision prior to enrollment, there must be gross...
- Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or how...
See the full eligibility criteria
- Histologically confirmed invasive, well-moderately differentiated rectal adenocarcinoma, mismatch repair proficient.
- MRI stage cT1 not eligible for transanal surgery or cT2-T3ab\ . \ T3a: \<1mm depth invasion, T3b: 1-5mm depth of invasion.
- 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 Gilbert's syndrome; Estimated creatinine clearance of ≥ 50ml/min
- Patient must have an ECOG performance of \<2 (or Karnofsty ≥ 60%).
- Must be accessible for treatment and follow-up
- Males and females of reproductive potential must have agreed to use a highly effective contraceptive method during and for 6 months after completion of chemotherapy.
- HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
- Pathologic high-risk factors on diagnostic biopsy: high histologic grade (poorly differentiated), mucinous or signet ring histology.
- Patients with visible pelvic sidewall nodes on MRI.
- Patients with unequivocal determination of nodal disease that, in the opinion of the investigator, would prohibit protocol therapy administration.
- Previous pelvic radiation for any reason, including brachytherapy alone.
- Patients who have had primary lesion excised prior to enrollment. If a patient has had partial excision prior to enrollment, there must be gross residual disease endoscopically for patient to be eligible.
- Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or how well it works assessment of the investigational regimen are eligible for...
- Prior treatment for rectal cancer.
- Patients with known dihydropyrimidine dehydrogenase deficiency (DYPD).
- Potential trial participants should have recovered from clinically significant adverse events of their most recent therapy/intervention prior to enrollment.
- Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association...
- Any contra-indications to undergo MRI imaging.
- Presence of anterior lesions above or near peritoneal reflection rendering the patient ineligible for a transanal tumour excision.
- T3 tumours invading or abutting the internal sphincter.
The study team makes the final eligibility decision.
Where it is enrolling
- Phoenix, Arizona, United States
- Irvine, California, United States
- Los Angeles, California, United States
- Orange, California, United States
- Santa Maria, California, United States
- Millville, Delaware, United States
- Newark, Delaware, United States
- Rehoboth Beach, Delaware, United States
- Atlanta, Georgia, United States
- Aurora, Illinois, United States
- Chicago, Illinois, United States
- Danville, Illinois, United States
- DeKalb, Illinois, United States
- Effingham, Illinois, United States
- Geneva, Illinois, United States
- Mattoon, Illinois, United States
- Urbana, Illinois, United States
- Warrenville, Illinois, United States
- Crown Point, Indiana, United States
- Dyer, Indiana, United States
+ 76 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The study runs about 5 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Phoenix, Arizona, United States; Irvine, California, United States; Los Angeles, California, United States; Orange, California, United States; Santa Maria, California, United States; Millville, Delaware, United States and 90 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.