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

Rectal Neoplasms Clinical Trial

— COMREC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05871762
• Other study ID #: 2022-PUMCH-C-027
• Status: Recruiting
• Start date: June 4, 2023
• Est. completion date: May 17, 2027

Study information

• Verified date: August 2023
• Source: Peking Union Medical College Hospital
• Contact: Yi Xiao, Professor
• Phone: +86 13366036387
• Email: Xiaoy[@]pumch.cn
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3705
• Est. completion date: May 17, 2027
• Est. primary completion date: May 17, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Rectal Neoplasms

Intervention

Other:
• Registry study, no specific intervention
Registry study, no specific intervention

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

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