Oncologic Risk of Rectal Preservation Against Medical Advice After Chemoradiotherapy for Rectal Cancer

Seoul National University

Status: Completed

Conditions: Chemoradiation; Rectal Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT03923309

B-1711/433-102

Details and patient eligibility

About

Though refusal of radical surgery was often happened in rectal cancer patient after neoadjuvant chemoradiotherapy, little is currently known about the actual oncologic outcome of it. Thus the investigators designed this study to compare the oncologic outcome of unintended rectal preservation with intended rectal preservation by surgeon.

Full description

The investigators identified patients whose organ were preserved by non-operative management or local excision after neoadjuvant chemoradiotherapy for mid to low rectal cancer. Then, the patients were categorized into two groups according to the agreement on omitting radical surgery (rectal preservation). When treatment decision was agreed by their surgeon, the patients were categorized as intended rectal preservation. When there was disagreement by surgeon on rectal preservation, then the patients categorized as unintended rectal preservation. Oncologic outcome was compared between two groups.

Enrollment: 142 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• biopsy proven rectal cancer (anal verge ≤ 10cm)
• neoadjuvant radiotherapy or chemoradiotherapy
• no radical surgery after neoadjuvant therapy

Exclusion criteria

• other malignant disease
• other fatel disease
• incompletion of half of radiotherapy course
• metastasis on initial presentation

Trial design

142 participants in 2 patient groups

Intended rectal preservation

Description:

When rectal preservation (non-operative management or local excision) was agreed by their surgeon.

Unintended rectal preservation

Description:

When rectal preservation (non-operative management or local excision) was disagreed by their surgeon.