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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05871762
Acronym
COMREC
Enrollment
3705
Registered
2023-05-23
Start date
2023-06-04
Completion date
2027-05-17
Last updated
2023-08-28

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

Conditions

Rectal Neoplasms

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.

Interventions

OTHERRegistry study, no specific intervention

Registry study, no specific intervention

Sponsors

Peking Union Medical College Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
3-year OS3 years3-year overall survival

Secondary

MeasureTime frameDescription
3-year LR3 years3-year local recurrence rate
3-year distant metastasis rate3 years3-year distant metastasis rate
neoadjuvant therapy rateat the time point of surgery of the primary lesionthe percentage of patients who underwent standard neoadjuvant therapy
adjuvant therapy rateat the time point of 3-year follow upthe percentage of patients who underwent standard adjuvant therapy
3-year DFS3 years3-year disease-free survival
R0 resection rateat the time point of surgery of the primary lesionthe percentage of patients who underwent R0 resection
CCRimmediately after the completion of neoadjuvant therapy assessmentClinical Complete Response
pCRimmediately after the completion of surgeryPathologic Complete Response
30-day mortality30 days after the surgerydeath occurring within 30 days of the surgery
EUS/MRI assessment rateat the time point of surgery of the primary lesionthe percentage of patients who underwent standard rectal EUS/MRI assessment

Countries

China

Contacts

Primary ContactYi Xiao, Professor
Xiaoy@pumch.cn+86 13366036387

Outcome results

None listed

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