Trial Title:
Neoadjuvant Chemotherapy, Excision And Observation vs Chemoradiotherapy For Rectal Cancer
NCT ID:
NCT06205485
Condition:
Rectal Cancer
Conditions: Official terms:
Rectal Neoplasms
Leucovorin
Capecitabine
Fluorouracil
Oxaliplatin
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Leucovorin
Description:
400 mg/m2
Arm group label:
FOLFOX OR CAPOX
Intervention type:
Drug
Intervention name:
Oxaliplatin
Description:
85 mg/m2 or 130 mg/m2 on day 1
Arm group label:
FOLFOX OR CAPOX
Intervention type:
Drug
Intervention name:
Fluoruracil
Description:
bolus fluoruracil (optional) 400 mg, infusional fluorouracil 2,400 mg/m2
Arm group label:
ChemoRT
Arm group label:
FOLFOX OR CAPOX
Intervention type:
Drug
Intervention name:
Capecitabine
Description:
1,000 mg/m2 twice daily for 14 days
Arm group label:
ChemoRT
Arm group label:
FOLFOX OR CAPOX
Intervention type:
Radiation
Intervention name:
Radiation
Description:
54 Gy (27-30 fractions)
Arm group label:
ChemoRT
Summary:
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?
Detailed description:
This study is being done to find out if this approach is better or worse than the usual
approach for early rectal cancer. The usual approach is defined as care most people get
for early rectal cancer.
The usual approach for patients who are not in a study is surgery to remove the rectum or
treatment with chemotherapy and radiation therapy, followed by surgery. There are several
chemotherapy drugs approved by Health Canada that are commonly used with radiation
therapy. For patients who get the usual approach for this cancer, about 90 out of 100 are
free of cancer after 5 years.
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 finishing treatment, and even if treatment is stopped early, the study doctor will
watch for side effects and determine which type of surgery would be best. 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. Patients may be seen more often if your study
doctor thinks it is necessary.
Criteria for 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.
- 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
- Women/men of childbearing 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, lymphatic/vascular or perineural
invasion.
- 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.
- 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
Address:
City:
Irvine
Zip:
92612
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
877-827-8839
Email:
ucstudy@uci.edu
Investigator:
Last name:
Jason A. Zell
Email:
Principal Investigator
Facility:
Name:
UC Irvine Health/Chao Family Comprehensive Cancer Center
Address:
City:
Orange
Zip:
92868
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
877-827-8839
Email:
ucstudy@uci.edu
Investigator:
Last name:
Jason A. Zell
Email:
Principal Investigator
Facility:
Name:
Helen F Graham Cancer Center
Address:
City:
Newark
Zip:
19713
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
302-623-4450
Email:
lbarone@christianacare.org
Investigator:
Last name:
Gregory A. Masters
Email:
Principal Investigator
Facility:
Name:
Medical Oncology Hematology Consultants PA
Address:
City:
Newark
Zip:
19713
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
302-623-4450
Email:
lbarone@christianacare.org
Investigator:
Last name:
Gregory A. Masters
Email:
Principal Investigator
Facility:
Name:
Northwestern University
Address:
City:
Chicago
Zip:
60611
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
312-695-1301
Email:
cancer@northwestern.edu
Investigator:
Last name:
Aparna Kalyan
Email:
Principal Investigator
Facility:
Name:
Carle at The Riverfront
Address:
City:
Danville
Zip:
61832
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
800-446-5532
Email:
Research@Carle.com
Investigator:
Last name:
Prem Sobti
Email:
Principal Investigator
Facility:
Name:
Carle Physician Group-Effingham
Address:
City:
Effingham
Zip:
62401
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
800-446-5532
Email:
Research@carle.com
Investigator:
Last name:
Prem Sobti
Email:
Principal Investigator
Facility:
Name:
Carle Physician Group-Mattoon/Charleston
Address:
City:
Mattoon
Zip:
61938
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
800-446-5532
Email:
Research@carle.com
Investigator:
Last name:
Prem Sobti
Email:
Principal Investigator
Facility:
Name:
Carle Cancer Center
Address:
City:
Urbana
Zip:
61801
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
800-446-5532
Email:
Research@carle.com
Investigator:
Last name:
Prem Sobti
Email:
Principal Investigator
Facility:
Name:
University of New Mexico Cancer Center
Address:
City:
Albuquerque
Zip:
87106
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
505-925-0348
Email:
HSC-ClinicalTrialInfo@salud.unm.edu
Investigator:
Last name:
Lara McKean Baste
Email:
Principal Investigator
Facility:
Name:
Miami Valley Hospital South
Address:
City:
Centerville
Zip:
45459
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
937-528-2900
Email:
clinical.trials@daytonncorp.org
Investigator:
Last name:
Tarek M. Sabagh
Email:
Principal Investigator
Facility:
Name:
University of Cincinnati Cancer Center-UC Medical Center
Address:
City:
Cincinnati
Zip:
45219
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
513-584-7698
Email:
cancer@uchealth.com
Investigator:
Last name:
Ian M. Paquette
Email:
Principal Investigator
Facility:
Name:
Miami Valley Hospital
Address:
City:
Dayton
Zip:
45409
Country:
United States
Status:
Suspended
Facility:
Name:
Premier Blood and Cancer Center
Address:
City:
Dayton
Zip:
45409
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
937-276-8320
Investigator:
Last name:
Tarek M. Sabagh
Email:
Principal Investigator
Facility:
Name:
Miami Valley Hospital North
Address:
City:
Dayton
Zip:
45415
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
937-528-2900
Email:
clinical.trials@daytonncorp.org
Investigator:
Last name:
Tarek M. Sabagh
Email:
Principal Investigator
Facility:
Name:
Atrium Medical Center-Middletown Regional Hospital
Address:
City:
Franklin
Zip:
45005-1066
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
937-528-2900
Email:
clinical.trials@daytonncorp.org
Investigator:
Last name:
Tarek M. Sabagh
Email:
Principal Investigator
Facility:
Name:
Miami Valley Cancer Care and Infusion
Address:
City:
Greenville
Zip:
45331
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
937-569-7515
Investigator:
Last name:
Tarek M. Sabagh
Email:
Principal Investigator
Facility:
Name:
Upper Valley Medical Center
Address:
City:
Troy
Zip:
45373
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
937-528-2900
Email:
clinical.trials@daytonncorp.org
Investigator:
Last name:
Tarek M. Sabagh
Email:
Principal Investigator
Facility:
Name:
University of Cincinnati Cancer Center-West Chester
Address:
City:
West Chester
Zip:
45069
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
513-584-7698
Email:
cancer@uchealth.com
Investigator:
Last name:
Ian M. Paquette
Email:
Principal Investigator
Facility:
Name:
Legacy Mount Hood Medical Center
Address:
City:
Gresham
Zip:
97030
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
503-413-2150
Investigator:
Last name:
Mei Dong
Email:
Principal Investigator
Facility:
Name:
Providence Newberg Medical Center
Address:
City:
Newberg
Zip:
97132
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
503-215-2614
Email:
CanRsrchStudies@providence.org
Investigator:
Last name:
Charles W. Drescher
Email:
Principal Investigator
Facility:
Name:
Providence Willamette Falls Medical Center
Address:
City:
Oregon City
Zip:
97045
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
503-215-2614
Email:
CanRsrchStudies@providence.org
Investigator:
Last name:
Charles W. Drescher
Email:
Principal Investigator
Facility:
Name:
Legacy Good Samaritan Hospital and Medical Center
Address:
City:
Portland
Zip:
97210
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
800-220-4937
Email:
cancer@lhs.org
Investigator:
Last name:
Mei Dong
Email:
Principal Investigator
Facility:
Name:
Providence Portland Medical Center
Address:
City:
Portland
Zip:
97213
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
503-215-2614
Email:
CanRsrchStudies@providence.org
Investigator:
Last name:
Charles W. Drescher
Email:
Principal Investigator
Facility:
Name:
Providence Saint Vincent Medical Center
Address:
City:
Portland
Zip:
97225
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
503-215-2614
Email:
CanRsrchStudies@providence.org
Investigator:
Last name:
Charles W. Drescher
Email:
Principal Investigator
Facility:
Name:
Oregon Health and Science University
Address:
City:
Portland
Zip:
97239
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
503-494-1080
Email:
trials@ohsu.edu
Investigator:
Last name:
Hagen F. Kennecke
Email:
Principal Investigator
Facility:
Name:
Legacy Meridian Park Hospital
Address:
City:
Tualatin
Zip:
97062
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
503-413-1742
Investigator:
Last name:
Mei Dong
Email:
Principal Investigator
Facility:
Name:
Christiana Care Health System-Concord Health Center
Address:
City:
Chadds Ford
Zip:
19317
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
302-623-4450
Email:
lbarone@christianacare.org
Investigator:
Last name:
Gregory A. Masters
Email:
Principal Investigator
Facility:
Name:
Virginia Mason Medical Center
Address:
City:
Seattle
Zip:
98101
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
206-287-6275
Email:
cancerresearch@virginiamason.org
Investigator:
Last name:
Huong T. Pham
Email:
Principal Investigator
Facility:
Name:
Legacy Cancer Institute Medical Oncology and Day Treatment
Address:
City:
Vancouver
Zip:
98684
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Email:
oncologyresearch@lhs.org
Investigator:
Last name:
Mei Dong
Email:
Principal Investigator
Facility:
Name:
Legacy Salmon Creek Hospital
Address:
City:
Vancouver
Zip:
98686
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
503-413-2150
Investigator:
Last name:
Mei Dong
Email:
Principal Investigator
Facility:
Name:
Marshfield Medical Center-Marshfield
Address:
City:
Marshfield
Zip:
54449
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
800-782-8581
Email:
oncology.clinical.trials@marshfieldresearch.org
Investigator:
Last name:
Rohit Sharma
Email:
Principal Investigator
Start date:
June 26, 2024
Completion date:
June 30, 2030
Lead sponsor:
Agency:
Canadian Cancer Trials Group
Agency class:
Other
Collaborator:
Agency:
Alliance for Clinical Trials in Oncology
Agency class:
Other
Collaborator:
Agency:
ECOG-ACRIN Cancer Research Group
Agency class:
Other
Collaborator:
Agency:
NRG Oncology
Agency class:
Other
Collaborator:
Agency:
SWOG Cancer Research Network
Agency class:
Other
Source:
Canadian Cancer Trials Group
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06205485
