NCT07688135

Brief Summary

This pilot study is being done to answer the following question: Will patients with margin-clear Stage 2 or 3 rectal cancer who don't require a colostomy agree to be randomized to 'surgery only' or 'chemotherapy and then surgery'? Study participants will be randomized to receive either 12 weeks of chemotherapy before rectal cancer surgery or they will proceed directly to surgery. The researchers hypothesize that patients with margin-clear clinical Stage II or III rectal cancer can avoid neo-adjuvant (i.e., pre-operative) radiation and chemotherapy treatments and go directly to surgery. A positive pilot study will support funding requests for a related large efficacy trial; this larger trial, if positive, should lead to an important de-escalation innovation - avoiding use of neo-adjuvant chemoradiation and associated toxicity risks for patients with margin-clear Stage II or III rectal cancer.

Trial Health

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
27mo left

Started Sep 2026

Typical duration for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 25, 2026

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 7, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2028

3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

July 7, 2026

Status Verified

June 1, 2026

Enrollment Period

2 years

First QC Date

June 25, 2026

Last Update Submit

June 30, 2026

Conditions

Stage III Rectal CancerStage II Rectal Cancer

Keywords

rectal cancerprospective randomized controlled trialchange patient caredirect-to-surgery

Outcome Measures

Primary Outcomes (1)

  • Accrual rate

    This pilot study is being conducted to assess the feasibility for a larger trial. Feasibility will be measured by the accrual rate in this pilot trial (i.e., the percent of patients who consent to participate).

    2 years

Secondary Outcomes (4)

  • Local recurrence

    2 years

  • Distant recurrence

    2 years

  • Survival

    2 years

  • Questionnaire: European Organization for Research and Treatment of Cancer - Quality of Life (QLQ-C30)

    2 years

Study Arms (2)

Surgery

EXPERIMENTAL
Procedure: Direct-to-surgery (i.e., no neoadjuvant chemotherapy)

Chemotherapy & Surgery

ACTIVE COMPARATOR

The current standard of care, which is 'neoadjuvant chemotherapy and surgery'

Procedure: Control Group

Interventions

Direct-to-surgery (i.e., no neoadjuvant chemotherapy)PROCEDURE

Patients with pre-operative margin-clear Stage II or III rectal cancer and expected avoidance of a permanent colostomy will undergo computer-generated randomization in a 1:1 ratio to an experimental 'direct-to-surgery' arm or a control 'neoadjuvant chemotherapy and surgery' arm.

Surgery
Control GroupPROCEDURE

This is the current standard of care in which patients receive neoadjuvant chemotherapy and surgery.

Chemotherapy & Surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • + years of age
  • able to provide written consent
  • MRI confirmed margin-clear Stage II or III rectal cancer

You may not qualify if:

  • patients with tumour criteria that encourage neoadjuvant treatments regardless of margin-status (e.g. need for a permanent colostomy, T4 category, and one or more pelvic sidewall lymph nodes with a short axis diameter \>7 mm).
  • Unable to provide consent (e.g., language barrier, cognitive issues).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Central Study Contacts

Erin D Kennedy, MD, PhD

CONTACT

416-586-4800erin.kennedy@sinaihealth.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Colorectal Surgeon

Study Record Dates

First Submitted

June 25, 2026

First Posted

July 7, 2026

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

September 1, 2028

Study Completion (Estimated)

December 1, 2028

Last Updated

July 7, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share