Clinical trial NCT04443985: A Cohort of Predictive Factor of Pathologic Complete Response After Preoperative Neoadjuvant in Rectum Cancer
Official title: A Cohort of Predictive Factor of Pathologic Complete Response After Preoperative Neoadjuvant in Rectum Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rectum Cancer
Keywords: Preoperative chemoradiation
Rectum cancer
Pathological complete response
Lead sponsor: Mahidol University
Sponsor class: OTHER
Collaborators: name: Ramathibodi Hospital
First posted: 2020-06-23
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who were diagnosed with rectal cancer and received chemoradiation

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* rectal cancer and received preoperative chemoradiation

Exclusion Criteria:

* distant organ metastasis
* previous colorectal surgery

Primary outcomes:
measure: Stage
timeFrame: 1 month
measure: Lymph node
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Chairat Supsamutchai
state: Bankok
Study officials:
affiliation: Ramathibodi Hospital, Mahidol University
name: Chairat Supsamutchai, MD
role: STUDY_CHAIR
References: