Development and Validation of The Post-RT LARS Prediction Model (PORTLARS)

Rectal Cancer Clinical Trial

— PORTLARS  

Official title:

Development and Validation of a Nomogram to Predict Severe Bowel Dysfunction After Rectal Cancer Resection and Neoadjuvant Radiotherapy: A Multicenter, Observational Clinical Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05129215
• Other study ID #: E2020016
• Status: Completed
• Start date: March 6, 2020
• Est. completion date: October 31, 2022

Study information

• Verified date: November 2022
• Source: Sixth Affiliated Hospital, Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Bowel dysfunction is common after a restorative rectal cancer resection. Neoadjuvant radiotherapy is an influential factor that impairs bowel function and quality of life. However, almost half patients who have received primary surgery with preoperative radiotherapy are able to restore a good or moderate bowel function in the long term. This multicenter observational study aims to identify the risk factors of severe bowel dysfunction after rectal cancer resection and neoadjuvant radiotherapy, in accordance with the LARS score, and to build a model that predicts long-term major LARS in the early stage of follow-up. Development and validation cohorts are enrolled from tertiary hospitals in China.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 901
• Est. completion date: October 31, 2022
• Est. primary completion date: October 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Curative low anterior resection for nonmetastatic rectal cancer

• Preoperative radiotherapy

Exclusion Criteria:

• Death

• Metastasis or recurrence

• Postoperative radiotherapy

• Cognitive disorder

• Intestinal stoma

• Rectal cancer resection for <12 months

• Stoma reversal for <6 months

Related Conditions & MeSH terms

• Low Anterior Resection Syndrome
• Radiotherapy
• Rectal Cancer
• Rectal Neoplasms

Intervention

Other:
• Questionnaire
The LARS score is used for assessment of bowel dysfunction after rectal cancer resection.

Locations

Country	Name	City	State
China	Sixth Affiliated Hospital, Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (3)

Lead Sponsor	Collaborator
Sixth Affiliated Hospital, Sun Yat-sen University	Beijing Friendship Hospital, Peking University Cancer Hospital & Institute

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Net reclassification index (NRI)	The additive NRI of PORTLARS compared to other models is evaluated by calculating the percentage of the 'actual major LARS' subjects correctly reclassified to the percentage of the 'actual no/minor LARS' subjects who are correctly reclassified.	Over one year after restorative rectal cancer resection
Primary	Area under the curve (AUC)	The AUC of PORTLARS in predicting major bowel dysfunction after restorative rectal cancer resection with neoadjuvant radiotherapy.; The AUC is evaluated by calculating the area under curve of receiver operating characteristics which plots the proportion of true positive cases (sensitivity) against the proportion of false positive cases (1-specificity) based on various predictive probability threshold.	Over one year after restorative rectal cancer resection
Secondary	Sensitivity	The sensitivity of PORTLARS in predicting major bowel dysfunction after restorative rectal cancer resection with neoadjuvant radiotherapy.; Model sensitivity is evaluated by calculating the proportion of the 'predicted major LARS' subjects among the total 'actual major LARS' subjects.	Over one year after restorative rectal cancer resection
Secondary	Specificity	The specificity of PORTLARS in predicting major bowel dysfunction after restorative rectal cancer resection with neoadjuvant radiotherapy.; Model specificity is evaluated by calculating the proportion of the 'predicted no/minor LARS' subjects among the total 'actual no/minor LARS' subjects.	Over one year after restorative rectal cancer resection
Secondary	Positive prediction value (PPV)	The PPV of PORTLARS in predicting major bowel dysfunction after restorative rectal cancer resection with neoadjuvant radiotherapy.; Model PPV is evaluated by calculating the proportion of the 'actual major LARS' subjects among the total 'predicted major LARS' subjects.	Over one year after restorative rectal cancer resection
Secondary	Negative prediction value (NPV)	The NPV of PORTLARS in predicting major bowel dysfunction after restorative rectal cancer resection with neoadjuvant radiotherapy.; Model NPV is evaluated by calculating the proportion of the 'actual no/minor LARS' subjects among the total 'predicted no/minor LARS' subjects.	Over one year after restorative rectal cancer resection