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NCT Number: NCT05871762

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

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.

Recruiting

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Key information

Conditions

Rectal Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location status: Recruiting

Location contact

Xiao Yi

CONTACT

[email protected]

+86 13366036387

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Registry study, no specific intervention

Other

Registry study, no specific intervention

Primary outcomes

  1. 3-year OS

    Time frame: 3 years

    3-year overall survival

Secondary outcomes

  1. 3-year DFS

    Time frame: 3 years

    3-year disease-free survival

  2. 3-year LR

    Time frame: 3 years

    3-year local recurrence rate

  3. 3-year distant metastasis rate

    Time frame: 3 years

    3-year distant metastasis rate

  4. neoadjuvant therapy rate

    Time frame: at the time point of surgery of the primary lesion

    the percentage of patients who underwent standard neoadjuvant therapy

  5. adjuvant therapy rate

    Time frame: at the time point of 3-year follow up

    the percentage of patients who underwent standard adjuvant therapy

  6. EUS/MRI assessment rate

    Time frame: at the time point of surgery of the primary lesion

    the percentage of patients who underwent standard rectal EUS/MRI assessment

  7. R0 resection rate

    Time frame: at the time point of surgery of the primary lesion

    the percentage of patients who underwent R0 resection

  8. CCR

    Time frame: immediately after the completion of neoadjuvant therapy assessment

    Clinical Complete Response

  9. pCR

    Time frame: immediately after the completion of surgery

    Pathologic Complete Response

  10. 30-day mortality

    Time frame: 30 days after the surgery

    death occurring within 30 days of the surgery

Study contacts

Contact information is provided by the study sponsor or research team.

Yi Xiao, Professor

CONTACT

[email protected]

+86 13366036387

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Registry information

Official study title

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

Acronym: COMREC

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
May 23, 2023
Registry last updated
Aug 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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