NEO: Neoadjuvant Chemotherapy, Excision and Observation for Early Rectal Cancer

Canadian Cancer Trials Group19 sites in 2 countries58 target enrollmentJune 29, 2018

ConditionsRectal Cancer

InterventionsFolfox Protocol Capox

DrugsCapox Folfox Protocol

Overview

Phase: Phase 2
Intervention: Folfox Protocol
Conditions: Rectal Cancer
Sponsor: Canadian Cancer Trials Group
Enrollment: 58
Locations: 19
Primary Endpoint: Percentage of Organ Preservation
Status: Completed
Last Updated: 23 days ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials Related News

Overview

Brief Summary

The purpose of this study is to find out the effects of chemotherapy followed by less invasive surgery on patients and their early rectal cancer. The approach of this trial will be considered a success if at least 65% of participants are able to keep the rectum.

Registry

clinicaltrials.gov

Start Date

June 29, 2018

End Date

April 25, 2024

Last Updated

23 days ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Canadian Cancer Trials Group

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Histologically confirmed invasive well-moderately differentiated rectal adenocarcinoma diagnosed within 90 days prior to enrollment.
•Tumour stage cT1-T3abN0 based on pelvic MRI
•cT1N0- tumour invasion into submucosa, no radiographic evidence of mesorectal nodal metastasis, tumour deposits or vascular invasion.
•cT2N0 - tumour invasion into muscularis propria, no radiographic evidence of mesorectal nodal metastasis, tumour deposits or vascular invasion.
•cT3a,bN0- tumour invasion through the muscularis propria no more than 5 mm into the subserosa/perirectal tissue and clear of the circumferential radial margin (CRM). Absence of radiographic evidence of mesorectal nodal metastasis, tumour deposits or lymphovascular invasion.
•Note: If the tumour is not visualized in the MRI but there is histological confirmation of rectal adenocarcinoma the patient is eligible.
•cN0 stage based on pelvic MRI. Any nodes ≥ 10 mm in longest dimension are considered malignant, regardless of nodal morphology. For pelvic nodes \< 10 mm in longest dimension, if nodes are seen and are deemed to be morphologically benign in the opinion of the radiologist and surgeon, the patient is eligible. Patients with visible pelvic sidewall nodes are excluded
•M0 stage based on no evidence of metastatic disease by CT imaging.
•Mid to low-lying tumour eligible for local tumour excision in the opinion of the treating surgeon.
•Age of at least 18 years.

Exclusion Criteria

•Patient has pathologic high risk factors on either the initial biopsy specimen report or follow-up biopsy (if done): high histologic grade, mucinous histology, lymphatic or vascular invasion.
•History of other malignancies, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for ≥ 5 years.
•Synchronous cancer.
•Prior treatment for rectal cancer.
•Previous pelvic radiation for any reason.
•Patients with known dihydropyrimidine dehydrogenase deficiency
•Treatment with other investigational drugs or anti-cancer therapy within 28 days prior to enrolment.
•Clinically significant (i.e. active) cardiovascular disease for example cerebro vascular accidents (\< 6 months prior to enrolment), myocardial infarction (\< 6 months prior to enrolment), unstable angina, New York Heart Association (NYHA) grade II or higher, congestive heart failure, serious cardiac arrhythmia requiring medication.
•Any contra-indications to undergo MRI imaging.