Treatment Strategy for Rectal Cancer Patients With Complete Clinical Response

Watch-and-wait Approach Versus Surgical Resection for Rectal Cancer Patients With Complete Clinical Response After Chemoradiotherapy: a Multi-center Cohort Study

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03846726

Enrollment

513

Registered

2019-02-20

Start date

2018-01-01

Completion date

2019-02-28

Last updated

2023-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rectal Cancer, Organ Preservation

Keywords

Rectal Cancer, clinical complete response

Brief summary

This was a propensity-score matched observational analysis, comparing the oncological outcome of surgical resection vs watch and wait apporach for rectal cancer patients with a cCR.

Detailed description

Pathologically confirmed stage II/III rectal adenocarcinoma patients who received neoadjuvant chemoradiotherapy followed by a clinical complete response from the year 2010 to 2018 were included. Sequential subjects were identified from a prospective maintained database in the Sun Yat-sen University Cancer Center. Clinical experts on rectal cancer from other 5 regional medical centers in China were also invited to participate, and provided data of cCR patients. Standardized forms for data collection were sanded to researchers in each center. Patients received radical resection will constituted our surgery group. Those refused surgery constituted the observation group who went on with the watch and wait approach. A propensity-score matched observational analysis will be used to compare the oncological outcome of these two groups.

Interventions

PROCEDUREstandard TME surgery

radical resection for rectal cancer

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

16 Years to 90 Years

Healthy volunteers

Inclusion criteria

* Pathologically confirmed stage II/III rectal adenocarcinoma patients who received neoadjuvant chemoradiotherapy followed by a clinical complete response

Exclusion criteria

* history of a second primary malignancy.

Design outcomes

Primary

Measure	Time frame	Description
PFS	the time from the date of treatment started until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months	progression-free survival

Secondary

Measure	Time frame	Description
OS	Overall survival was calculated from the date of first treatment until death from any cause or was censored at last follow-up, assessed up to 60 months	overall survival

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026