RECRUITING

Neoadjuvant Chemotherapy, Excision And Observation vs Chemoradiotherapy For Rectal Cancer

Talk to us

Conditions

Rectal Cancer

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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?

Official Title

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

Quick Facts

Study Start:2024-06-26
Study Completion:2030-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06205485

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Histologically confirmed invasive, well-moderately differentiated rectal adenocarcinoma, mismatch repair proficient.
  2. * MRI stage cT1 not eligible for transanal surgery or cT2.
  3. * cN0 stage based on pelvic MRI - including absence of radiographic evidence of mesorectal nodal metastasis, tumour deposits or extramural venous invasion (EMVI).
  4. * M0 stage based on no evidence of metastatic disease by CT imaging of chest, abdomen and pelvis.
  5. * Mid to low-lying tumour eligible for transanal excision in the opinion of the treating surgeon.
  6. * Medically fit to undergo radical TME surgery as per treating surgeon's decision.
  7. * Participant is able (i.e. sufficiently fluent) and willing to complete the quality of life questionnaires in either English or French or Spanish.
  8. * Age of at least 18 years.
  9. * No contraindications to protocol chemotherapy.
  10. * 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
  11. * Patient must have an ECOG performance of \<2 (or Karnofsty ≥ 60%).
  12. * Must be accessible for treatment and follow-up
  13. * Women/men of childbearing potential must have agreed to use a highly effective contraceptive method during and for 6 months after completion of chemotherapy.
  14. * HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
  1. * Pathologic high-risk factors on diagnostic biopsy: high histologic grade (poorly differentiated), mucinous or signet ring histology, lymphatic/vascular or perineural invasion.
  2. * Patients with visible pelvic sidewall nodes on MRI.
  3. * Patients with unequivocal determination of nodal disease that, in the opinion of the investigator, would prohibit protocol therapy administration.
  4. * Previous pelvic radiation for any reason, including brachytherapy alone.
  5. * Patients who have had primary lesion excised prior to enrollment.
  6. * 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.
  7. * Prior treatment for rectal cancer.
  8. * Patients with known dihydropyrimidine dehydrogenase deficiency (DYPD).
  9. * Potential trial participants should have recovered from clinically significant adverse events of their most recent therapy/intervention prior to enrollment.
  10. * 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.
  11. * Any contra-indications to undergo MRI imaging.
  12. * Presence of anterior lesions above or near peritoneal reflection rendering the patient ineligible for a transanal tumour excision.

Contacts and Locations

Study Contact

Chris O'Callaghan
CONTACT
613-533-6430
cocallaghan@ctg.queensu.ca

Principal Investigator

Hagen Kennecke
STUDY_CHAIR
Providence Portland Medical Centre, Portland, OR, USA
Carl Brown
STUDY_CHAIR
St. Paul's Hospital, Vancouver, BC, Canada

Study Locations (Sites)

UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
Irvine, California, 92612
United States
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California, 92868
United States
Beebe South Coastal Health Campus
Millville, Delaware, 19967
United States
Helen F Graham Cancer Center
Newark, Delaware, 19713
United States
Medical Oncology Hematology Consultants PA
Newark, Delaware, 19713
United States
Beebe Health Campus
Rehoboth Beach, Delaware, 19971
United States
Northwestern University
Chicago, Illinois, 60611
United States
Carle at The Riverfront
Danville, Illinois, 61832
United States
Carle Physician Group-Effingham
Effingham, Illinois, 62401
United States
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois, 61938
United States
Carle Cancer Center
Urbana, Illinois, 61801
United States
Northwest Cancer Center - Main Campus
Crown Point, Indiana, 46307
United States
Northwest Oncology LLC
Dyer, Indiana, 46311
United States
Northwest Cancer Center - Hobart
Hobart, Indiana, 46342
United States
Saint Mary Medical Center
Hobart, Indiana, 46342
United States
The Community Hospital
Munster, Indiana, 46321
United States
Northwest Cancer Center - Valparaiso
Valparaiso, Indiana, 46383
United States
Renown Regional Medical Center
Reno, Nevada, 89502
United States
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87106
United States
Miami Valley Hospital South
Centerville, Ohio, 45459
United States
University of Cincinnati Cancer Center-UC Medical Center
Cincinnati, Ohio, 45219
United States
Miami Valley Hospital
Dayton, Ohio, 45409
United States
Premier Blood and Cancer Center
Dayton, Ohio, 45409
United States
Miami Valley Hospital North
Dayton, Ohio, 45415
United States
Atrium Medical Center-Middletown Regional Hospital
Franklin, Ohio, 45005-1066
United States
Miami Valley Cancer Care and Infusion
Greenville, Ohio, 45331
United States
Upper Valley Medical Center
Troy, Ohio, 45373
United States
University of Cincinnati Cancer Center-West Chester
West Chester, Ohio, 45069
United States
Clackamas Radiation Oncology Center
Clackamas, Oregon, 97015
United States
Legacy Mount Hood Medical Center
Gresham, Oregon, 97030
United States
Providence Newberg Medical Center
Newberg, Oregon, 97132
United States
Providence Willamette Falls Medical Center
Oregon City, Oregon, 97045
United States
Legacy Good Samaritan Hospital and Medical Center
Portland, Oregon, 97210
United States
Providence Portland Medical Center
Portland, Oregon, 97213
United States
Providence Saint Vincent Medical Center
Portland, Oregon, 97225
United States
Oregon Health and Science University
Portland, Oregon, 97239
United States
Legacy Meridian Park Hospital
Tualatin, Oregon, 97062
United States
Christiana Care Health System-Concord Health Center
Chadds Ford, Pennsylvania, 19317
United States
Virginia Mason Medical Center
Seattle, Washington, 98101
United States
Legacy Cancer Institute Medical Oncology and Day Treatment
Vancouver, Washington, 98684
United States
Legacy Salmon Creek Hospital
Vancouver, Washington, 98686
United States
Marshfield Medical Center-EC Cancer Center
Eau Claire, Wisconsin, 54701
United States
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin, 54449
United States
Marshfield Medical Center - Minocqua
Minocqua, Wisconsin, 54548
United States
Marshfield Medical Center-Rice Lake
Rice Lake, Wisconsin, 54868
United States
Marshfield Medical Center-River Region at Stevens Point
Stevens Point, Wisconsin, 54482
United States
Marshfield Medical Center - Weston
Weston, Wisconsin, 54476
United States

Collaborators and Investigators

Sponsor: Canadian Cancer Trials Group

  • Hagen Kennecke, STUDY_CHAIR, Providence Portland Medical Centre, Portland, OR, USA
  • Carl Brown, STUDY_CHAIR, St. Paul's Hospital, Vancouver, BC, Canada

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-06-26
Study Completion Date2030-06-30

Study Record Updates

Study Start Date2024-06-26
Study Completion Date2030-06-30

Terms related to this study

Additional Relevant MeSH Terms

  • Rectal Cancer