Trial · NCT03259035

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

NCT03259035, Phase 2, Completed, Canadian Cancer Trials Group; results first posted 2024-10-10

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. NEO: Neoadjuvant Chemotherapy, Excision and Observation for Early Rectal Cancer. Trials, record NCT03259035. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03259035

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: NEO: Neoadjuvant Chemotherapy, Excision and Observation for Early Rectal Cancer
NCT number: NCT03259035
Status: Completed
Phases: Phase 2
Enrollment: 58 participants, actual
Lead sponsor: Canadian Cancer Trials Group
Conditions: Rectal Cancer
Interventions: Folfox Protocol, Capox
First posted: 2017-08-23
Last updated: 2026-04-09
Results first posted: 2024-10-10

Source ClinicalTrials.gov

Registered outcomes5

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Percentage of Organ Preservation	3 years	Defined as the percentage of patients with tumour downstaging to ypT0/T1good N0 and who avoid radical surgery.
Secondary	Percentage of Locoregional Relapses at 3 Years	3 years	Locoregional relapse is defined as reappearance of a tumour within the rectum or pelvis. The percentage of loco-reginal relapse at 3 years was estimated by Kaplan-Meier method for the survival function of the loco-regional relapse free survival, defined as the time from enrollment to the first date of definitive evidence (clinical, radiological or pathological) of locoregional relapses with patients who developed distant relapse only, died, loss to follow up, or were alive at clinical cut-off censored at respectively at last date of distant relapses, date of death, date of lost to follow-up, or last disease assessment date.
Secondary	Percentage of Distant Relapse at 3 Years	3 years	Distant relapse is defined as appearance of rectal cancer disease at sites remote from the rectum. The percentage of distant relapse at 3 years was estimated also by Kaplan-Meier method for the survival function of the distant free survival, defined as the time from enrollment to the first date of definitive evidence (clinical, radiological or pathological) of distant relapses with patients who died, loss to follow up, or were alive at clinical cut-off censored at respectively: date of death, date of lost to follow-up, and last disease assessment date.
Secondary	Percentage of Disease Free at 3 Years	3 years	Percentage of disease free at 3 years was estimated by Kaplan-Meier method for the survival function of Disease-Free Survival (DFS), which is defined as the interval from date of enrollment to the first date of the events defined below: * Locoregional relapse * Distant relapse * Non-protocol radiotherapy, chemotherapy, or biologic therapy without documentation of the site of failure * Death due to any other reason. Patients who were alive without locoregional or distant relapse or receiving non-protocol radiotherapy, chemotherapy, or biologic therapy without documentation of the site of failure at the clinical data cutoff date were censored at their last disease assessment date. 3 year disease free survival was estimated by Kaplan-Meier method.
Secondary	Rate of Intraoperative Complications	1 day	Percentage of patients with at least one intraoperative injury

Source ClinicalTrials.gov

Outcomes5

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Percentage of Organ Preservation	3 years	All participants who had chemotherapy.	percentage of participants	NUMBER
SECONDARY	Percentage of Locoregional Relapses at 3 Years	3 years	All patients enrolled	percentage of participants	NUMBER
SECONDARY	Percentage of Distant Relapse at 3 Years	3 years	All participants enrolled	percentage of participants	NUMBER
SECONDARY	Percentage of Disease Free at 3 Years	3 years	All participants enrolled.	percentage of participants	NUMBER
SECONDARY	Rate of Intraoperative Complications	1 day	Patients who had BOTH chemotherapy and tumor excision with transanal endoscopic microsurgery (TEM) or transanal minimally invasive surgery (TAMIS)	percentage of participants	NUMBER

Source ClinicalTrials.gov

Results by group5

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Percentage of Organ Preservation	Chemotherapy (FOLFOX or CAPOX) Followed by Tumour Excision	57	90% Confidence Interval 45 to 68	percentage of participants
Percentage of Locoregional Relapses at 3 Years	Chemotherapy (FOLFOX or CAPOX) Followed by Tumour Excision	7.1	95% Confidence Interval 2.7 to 17.7	percentage of participants
Percentage of Distant Relapse at 3 Years	Chemotherapy (FOLFOX or CAPOX) Followed by Tumour Excision	5.3	95% Confidence Interval 1.7 to 15.4	percentage of participants
Percentage of Disease Free at 3 Years	Chemotherapy (FOLFOX or CAPOX) Followed by Tumour Excision	84.3	95% Confidence Interval 72.0 to 91.5	percentage of participants
Rate of Intraoperative Complications	Chemotherapy (FOLFOX or CAPOX) Followed by Tumour Excision	1.89		percentage of participants

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Stage 1: Chemotherapy	STARTED	Chemotherapy (FOLFOX or CAPOX) Followed by Tumour Excision	58
Stage 1: Chemotherapy	COMPLETED	Chemotherapy (FOLFOX or CAPOX) Followed by Tumour Excision	58
Stage 1: Chemotherapy	NOT COMPLETED	Chemotherapy (FOLFOX or CAPOX) Followed by Tumour Excision	0
Stage 2: Tumor Excision	STARTED	Chemotherapy (FOLFOX or CAPOX) Followed by Tumour Excision	56
Stage 2: Tumor Excision	COMPLETED	Chemotherapy (FOLFOX or CAPOX) Followed by Tumour Excision	56
Stage 2: Tumor Excision	NOT COMPLETED	Chemotherapy (FOLFOX or CAPOX) Followed by Tumour Excision	0

Source ClinicalTrials.gov

Adverse events60

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Watering eyes	Eye disorders	Chemotherapy (FOLFOX or CAPOX) Followed by Tumour Excision	3	58
other	Abdominal pain	Gastrointestinal disorders	Chemotherapy (FOLFOX or CAPOX) Followed by Tumour Excision	11	58
other	Bloating	Gastrointestinal disorders	Chemotherapy (FOLFOX or CAPOX) Followed by Tumour Excision	5	58
other	Constipation	Gastrointestinal disorders	Chemotherapy (FOLFOX or CAPOX) Followed by Tumour Excision	24	58
other	Diarrhea	Gastrointestinal disorders	Chemotherapy (FOLFOX or CAPOX) Followed by Tumour Excision	32	58
other	Dyspepsia	Gastrointestinal disorders	Chemotherapy (FOLFOX or CAPOX) Followed by Tumour Excision	8	58
other	Dysphagia	Gastrointestinal disorders	Chemotherapy (FOLFOX or CAPOX) Followed by Tumour Excision	4	58
other	Flatulence	Gastrointestinal disorders	Chemotherapy (FOLFOX or CAPOX) Followed by Tumour Excision	7	58
other	Gastroesophageal reflux disease	Gastrointestinal disorders	Chemotherapy (FOLFOX or CAPOX) Followed by Tumour Excision	9	58
other	Mucositis oral	Gastrointestinal disorders	Chemotherapy (FOLFOX or CAPOX) Followed by Tumour Excision	22	58

1 to 10 of 60Source ClinicalTrials.gov

See all 60 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Chemotherapy (FOLFOX or CAPOX) Followed by Tumour Excision	2	58
Total, other adverse events	Chemotherapy (FOLFOX or CAPOX) Followed by Tumour Excision	58	58
Total, serious adverse events	Chemotherapy (FOLFOX or CAPOX) Followed by Tumour Excision	1	58

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
35981270	RESULT

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT03259035

GET https://conductscience.org/api/trials/v1/NCT03259035/events?page=2

API reference For AI assistants