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

NCT ID: NCT03259035

Last Updated: 2024-10-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-29
• Study Completion Date: 2024-04-25

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

chemotherapy (FOLFOX or CAPOX) followed by tumour excision

Group Type: EXPERIMENTAL

Folfox Protocol

Intervention Type: DRUG

6 cycles of q2weekly FOLFOX, or

Capox

Intervention Type: DRUG

4 cycles of q3weekly CAPOX

Interventions

Folfox Protocol

6 cycles of q2weekly FOLFOX, or

Intervention Type: DRUG

Capox

4 cycles of q3weekly CAPOX

Intervention Type: DRUG

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.
• 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
• bilirubin < 1.5 ULN, excluding Gilbert's syndrome
• Calculated creatinine clearance of ≥ 50 ml/min.
• Clearance to be calculated using Cockcroft formula: Males: 1.23 x (140 - age) x weight (kg) - serum creatinine (μmol/l) ; Females: 1.05 x (140 - age) x weight (kg) - serum creatinine (μmol/l)
• The patient must have an ECOG performance status of 0, 1.
• Patient is able (i.e. sufficiently fluent) and willing to complete the quality of life and health utility questionnaires.
• Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each patient must sign a consent form prior to enrollment in the trial to document their willingness to participate.
• Must be accessible for treatment and follow up. Patients registered on this trial must be treated with chemotherapy and followed at the enrolling centre.
• Protocol treatment is to begin within 5 working days of patient enrollment.
• Women/men of childbearing potential must have agreed to use a highly effective contraceptive method during and for 6 months after completion of chemotherapy.

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Canadian Cancer Trials Group

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hagen Kennecke

Role: STUDY_CHAIR

Virginia Mason Medical Centre, WA USA

Carl Brown

Role: STUDY_CHAIR

St. Paul's Hospital, Vancouver BC

Locations

UC Irvine Medical Center

Orange, California, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Virginia Mason Medical Center

Seattle, Washington, United States

BCCA - Vancouver Cancer Centre

Vancouver, British Columbia, Canada

St. Paul's Hospital

Vancouver, British Columbia, Canada

CancerCare Manitoba

Winnipeg, Manitoba, Canada

QEII Health Sciences Centre

Halifax, Nova Scotia, Canada

Health Sciences North

Greater Sudbury, Ontario, Canada

Kingston Health Sciences Centre

Kingston, Ontario, Canada

Ottawa Hospital Research Institute

Ottawa, Ontario, Canada

The Research Institute of the McGill University

Montreal, Quebec, Canada

Countries

United States; Canada

References

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.

Reference Type: RESULT

PMID: 35981270 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

CO28

Identifier Type: -

Identifier Source: org_study_id