RecruitingPhase 3

Neoadjuvant Chemotherapy, Excision And Observation vs Chemoradiotherapy For Rectal Cancer

A Phase 3 Randomized Trial Of Neoadjuvant Chemotherapy, Excision And Observation Versus Chemoradiotherapy For Early Rectal Cancer

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 12 weeks, 6 weeks, 2 years, 5 years

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "If a patient decides to take part in this study, they will either get a combination of chemotherapy drugs called FOLFOX or CAPOX for up to 12 weeks or will get chemotherapy with radiation therapy for up to 6 weeks."
  • "After surgery, patients will be asked to come in every 4 months for 2 years, then every 6 months for an additional year."
  • "Then will be checked every year for 2 years."
  • "This means seeing the study doctor for up to 5 years after surgery."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study is for adults with rectal cancer that has not spread to lymph nodes or distant parts of the body. It compares chemotherapy alone with chemotherapy plus radiation before limited surgery to remove the tumor. It also asks whether skipping radiation leads to better quality of life.

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?

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 18 or older.
  • Have rectal adenocarcinoma, a cancer of gland cells, confirmed by a tissue sample. The cells must look fairly close to normal and have a working DNA repair system.
  • Have a tumor at one of the allowed stages on MRI: T1 not suited for surgery through the anus, T2, or early T3 with spread no more than 5 mm beyond the rectal muscle.
  • Scans must show no cancer in nearby lymph nodes or distant organs, no separate nearby tumor deposits, and no cancer in veins outside the rectum.
  • Have a tumor in the middle or lower rectum that the surgeon can remove through the anus. Also be healthy enough for major rectal surgery if needed.
  • Be able to receive the study chemotherapy, with enough organ and bone marrow function and ability to do daily activities.
  • Be able to attend treatment and follow-up visits and willing and able to fill out quality-of-life forms in English, French, or Spanish.
  • If able to have or father a child, agree to use highly effective birth control during chemotherapy and for 6 months after it ends.

Who can't join

  • A tissue sample shows high-risk cancer cells: cells that look very abnormal, mucus-producing cancer, or signet ring cells.
  • MRI shows lymph nodes along the side of the pelvis, or clear cancer in lymph nodes prevents study treatment.
  • Past radiation to the pelvis or prior treatment for rectal cancer.
  • The main tumor was fully removed before joining. After partial removal, visible cancer must still remain on an exam with a scope.
  • Known DPD deficiency, a lack of an enzyme needed to break down some chemotherapy drugs.
  • Serious side effects from recent treatment have not cleared, or heart function does not meet the study's safety requirements.
  • Cannot safely have an MRI.
  • The tumor's location prevents removal through the anus, or a T3 tumor touches or grows into the inner muscle that controls bowel movements.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion 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. Exclusion Criteria: * 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 efficacy assessment of the investigational regimen are eligible for this trial. * 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 Functional Classification. To be eligible for this trial, patients should be class 2B or better. * 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.

Study sites (105)

AZ

CA

DE

FL

GA

  • Emory University Hospital Midtown · Atlanta, GA 30308Site Public Contact · Study contact · 888-946-7447Patrick S. Sullivan · Principal investigatorMore trials in Atlanta
  • Emory University Hospital/Winship Cancer Institute · Atlanta, GA 30322Site Public Contact · Study contact · 404-778-1868Patrick S. Sullivan · Principal investigatorMore trials in Atlanta
  • Emory Saint Joseph's Hospital · Atlanta, GA 30342Site Public Contact · Study contact · 404-851-7115Patrick S. Sullivan · Principal investigatorMore trials in Atlanta

IL

IN

LA

MA

MI

MN

MO

NC

ND

NH

NJ

NM

NV

NY

OH

OR

PA

SD

TN

TX

VT

WA

WI