COMREC: Choice of the Optimal Treatment Strategies for Mid-low REctal Cancer

Sponsor

Peking Union Medical College Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05871762

Collaborator

(none)

3,705

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The purpose of this study is to compare the efficacy, prognosis, health economics of different treatment modalities of mid-low rectal cancer in different centers in China, and to conduct cost utility analysis (CUA) on the treatment process of rectal cancer to explore the best treatment modality that meets the actual need of medical units in each region and at each level. The investigators hope to provide evidence-based medical suggestions for medical quality control of rectal cancer and revision of clinical guidelines, and provides a source of decision making for medical management and medical insurance.

Condition or Disease	Intervention/Treatment	Phase
Rectal Neoplasms	Other: Registry study, no specific intervention

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

3705 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Choice of the Optimal Treatment Strategies for Mid-low REctal Cancer-a National Multi-center, Prospective, Real World Study

Anticipated Study Start Date :

May 17, 2023

Anticipated Primary Completion Date :

May 17, 2027

Anticipated Study Completion Date :

May 17, 2027

Outcome Measures

Primary Outcome Measures

3-year OS [3 years]
3-year overall survival

Secondary Outcome Measures

3-year DFS [3 years]
3-year disease-free survival
3-year LR [3 years]
3-year local recurrence rate
3-year distant metastasis rate [3 years]
3-year distant metastasis rate
neoadjuvant therapy rate [at the time point of surgery of the primary lesion]
the percentage of patients who underwent standard neoadjuvant therapy
adjuvant therapy rate [at the time point of 3-year follow up]
the percentage of patients who underwent standard adjuvant therapy
EUS/MRI assessment rate [at the time point of surgery of the primary lesion]
the percentage of patients who underwent standard rectal EUS/MRI assessment
R0 resection rate [at the time point of surgery of the primary lesion]
the percentage of patients who underwent R0 resection
CCR [immediately after the completion of neoadjuvant therapy assessment]
Clinical Complete Response
pCR [immediately after the completion of surgery]
Pathologic Complete Response
30-day mortality [30 days after the surgery]
death occurring within 30 days of the surgery

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

pathologically confirmed rectal adenocarcinoma
located within 12cm below the anal verge

Exclusion Criteria:

diagnosed with distant metastasis
multiple primary colorectal cancers
history of previous malignant tumors
Pregnant or lactating women

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Peking Union Medical College Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Peking Union Medical College Hospital

ClinicalTrials.gov Identifier:

NCT05871762

Other Study ID Numbers:

2022-PUMCH-C-027

First Posted:

May 23, 2023

Last Update Posted:

May 23, 2023

Last Verified:

May 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Rectal Neoplasms

Study Results

No Results Posted as of May 23, 2023