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

NCT03259035 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: CO28
• Study Type: interventional
• Target: 58
• Locations: 2 countries
• Sites: 11

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.

Conditions

Rectal Cancer

Outcome Measures

Primary Outcomes (1)

• Percentage of Organ Preservation

  Defined as the percentage of patients with tumour downstaging to ypT0/T1good N0 and who avoid radical surgery.

  3 years

Secondary Outcomes (4)

• Percentage of Locoregional Relapses at 3 Years

  3 years

• Percentage of Distant Relapse at 3 Years

  3 years

• Percentage of Disease Free at 3 Years

  3 years

• Rate of Intraoperative Complications

  1 day

Study Arms (1)

chemotherapy (FOLFOX or CAPOX) followed by tumour excision

EXPERIMENTAL

Drug: Folfox Protocol; Drug: Capox

Interventions

Folfox Protocol DRUG

6 cycles of q2weekly FOLFOX, or

chemotherapy (FOLFOX or CAPOX) followed by tumour excision

Capox DRUG

4 cycles of q3weekly CAPOX

chemotherapy (FOLFOX or CAPOX) followed by tumour excision

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Medically fit to undergo radical surgery as per treating surgeon's discretion
• No contraindications to protocol chemotherapy.
• Adequate normal organ and marrow function as defined below (must be done within 30 days prior to enrolment):
• ANC ≥ 1.5 x 109/L
• platelet count ≥100 x 109/L

You may not qualify if:

• 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.

Sponsors & Collaborators

• Canadian Cancer Trials Group: lead

Study Sites (11)

UC Irvine Medical Center

Orange, California, 92868, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Virginia Mason Medical Center

Seattle, Washington, 97101, United States

Location

BCCA - Vancouver Cancer Centre

Vancouver, British Columbia, V5Z 4E6, Canada

Location

St. Paul's Hospital

Vancouver, British Columbia, V6Z 1Y6, Canada

Location

CancerCare Manitoba

Winnipeg, Manitoba, R3E 0V9, Canada

Location

QEII Health Sciences Centre

Halifax, Nova Scotia, B3H 1V7, Canada

Location

Health Sciences North

Greater Sudbury, Ontario, P3E 5J1, Canada

Location

Kingston Health Sciences Centre

Kingston, Ontario, K7L 2V7, Canada

Location

Ottawa Hospital Research Institute

Ottawa, Ontario, K1H 8L6, Canada

Location

The Research Institute of the McGill University

Montreal, Quebec, H4A 3J1, Canada

Location

Related Publications (1)

• Kennecke HF, O'Callaghan CJ, Loree JM, Moloo H, Auer R, Jonker DJ, Raval M, Musselman R, Ma G, Caycedo-Marulanda A, Simianu VV, Patel S, Pitre LD, Helewa R, Gordon VL, Neumann K, Nimeiri H, Sherry M, Tu D, Brown CJ. Neoadjuvant Chemotherapy, Excision, and Observation for Early Rectal Cancer: The Phase II NEO Trial (CCTG CO.28) Primary End Point Results. J Clin Oncol. 2023 Jan 10;41(2):233-242. doi: 10.1200/JCO.22.00184. Epub 2022 Aug 18.

  PMID: 35981270 RESULT

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Folfox protocol

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Results Point of Contact

• Title: Dr. Chris O'Callaghan
• Organization: Canadian Cancer Trials Group

cocallaghan@ctg.queensu.ca

6135336430

Study Officials

• Hagen Kennecke

  Virginia Mason Medical Centre, WA USA

  STUDY CHAIR

• Carl Brown

  St. Paul's Hospital, Vancouver BC

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Model Details: This is a two staged, single arm phase II trial of chemotherapy (FOLFOX or CAPOX) followed by tumour excision in patients with early stage rectal cancer

Study Record Dates

• First Submitted: August 21, 2017
• First Posted: August 23, 2017
• Study Start: June 29, 2018
• Primary Completion: April 8, 2024
• Study Completion: April 25, 2024
• Last Updated: April 9, 2026
• Results First Posted: October 10, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (8); US (3)