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Completed

NCT Number: NCT04443985

A Cohort of Predictive Factor of Pathologic Complete Response After Preoperative Neoadjuvant in Rectum Cancer

Due to colorectal cancer is the fourth most common malignancy in the world. Some patients had present locally advance stage and need to preoperative concurrent chemoradiation (CCRT) before radical surgery. But predictor for pathologic complete response (pCR) after preoperative CCRT remain unclear.

Objectives: To identify possible factor for predict of pCR of rectal cancer after preoperative CCRT.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chairat Supsamutchai

Bangkok, Bankok, 10400, Thailand

About this study

After permission was obtained from our institutional review board, a cohort of patients who were diagnosed with rectal cancer and received chemoradiation between January 2011 to December 2017 at Ramathibodi hospital, Bangkok were analyzed. Patients who were not received neoadjuvant chemoradiation therapy, loss follow-up, incomplete data in the record, distant organ metastasis and who was not received colorectal surgery were excluded as study flow diagram. Age, sex, performance status, smoking, initial Hb level (g/mL), CEA level (ng/dL), distance of tumor from anal verge, diagnostic variables, clinical T staging, preoperative thickness and length from computer tomography scan (CT scan), organ metastasis before treatment, histology, treatment course, and outcomes after treatment were collected and analyzed.Total dose of radiation, interval time from CCRT to operation, and chemotherapy regimens were also collected between and after treatment. After preoperative CCRT, the radical rectal surgery was performed by eight experienced general surgeons and surgical oncologist using open and laparoscopic techniques. Perioperative data were collected and histology was evaluated by an experienced pathologists. For pathological classification, pathological responses were divided in 2 groups i.e., pathologic complete response (pCR group) and non-pCR group, (partial response, stable disease, and disease progression). Margin of lesions were classified as proximal, distal and circumferential margins. Lymph nodes status after surgery were specified as total lymph nodes harvested and positive lymph nodes.

Who can participate

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

Inclusion criteria

  • rectal cancer and received preoperative chemoradiation

Exclusion criteria

  • distant organ metastasis
  • previous colorectal surgery

Treatment and study plan

Primary outcomes

  1. Stage

    Time frame: 1 month

    Pathological of Tumor follow by The American Joint Committee on Cancer (AJCC) edition 8

  2. Lymph node

    Time frame: 1 month

    Pathological of lymph node follow by The American Joint Committee on Cancer (AJCC) edition 8

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Collaborators

  • Ramathibodi Hospital

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jun 23, 2020
Registry last updated
May 20, 2022

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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