Observational Study on the Patients With Rectal Cancer

Completed

• Conditions: Adjuvant Chemotherapy; Rectal Cancer; Surgery; Adjuvant Chemoradiotherapy; Neoadjuvant Chemoradiotherapy

• Registration Number: NCT02312284
• Lead Sponsor: Chinese Academy of Medical Sciences

Brief Summary

The aim of this observational study is to retrospectively collect current survival data for 3995 primary rectal cancer patients who were extracted from 5097 rectal cancer patients admitted in Cancer Hospital, Chinese Academy of Medical Sciences from January 2000 to December 2010. Moreover, based on a Cox model, we want to develope a nomogram that predicts local recurrence, distant metastases, and survival for patients with rectal cancer treated with pre- or postoperative chemoradiotherapy (CRT).

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Primary Completion: 2014-11
• Study Completion: 2014-11
• Study First Submitted: 2014-12-04
• Study First Submitted QC: 2014-12-06
• Study First Posted: 2014-12-09
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-14
• Last Update Posted: 2016-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3995

Inclusion Criteria

• Aged older than 18 years
• American Joint Committee on Cancer (six edition) stage I through IV disease
• Received either transabdominal resection, transanal excision, preoperative radiotherapy or chemoradiotherapy
• Had the histologic subtypes adenocarcinoma (not otherwise specified, mucinous or mucin-producing, mixed cell or with mixed subtypes, tubular, and papillary)

Exclusion Criteria

• Had the histologic subtypes squamous cell carcinoma, carcinoid, neuroendocrine tumor, small cell carcinoma, leiomyosarcoma, sarcoma, gastrointestinal stromal sarcoma, melanoma, carcinosarcoma, rhabdoid tumors, or malignant peripheral nerve sheet tumors
• Only receive palliative surgery such as colostomy, sigmoidostomy
• Received palliative radiotherapy or chemoradiotherapy for metastatic disease
• With unresectable distant metastasis in liver, lung, bone, central nervous system , or peritoneal transplantation
• Had no detailed medical records

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Locoregional recurrence free survival	5-10 years
Distant metastasis free survival	5-10 years
Overall survival	5-10 years
Cancer-specific survival	5-10 years

Secondary Outcome Measures

Name	Time	Method
Surgery complication	within 30 days after surgery
Chemotherapy/Radiotherapy/Chemoradiotherapy toxicities	the duration of hospital stay (an expected average of 6 weeks for chemoradiotherapy and 4-6 months for chemotherapy), as well as within 30 days after completion of the treatment and all the follow-up time	Chemotherapy toxicities are evaluated by NCI-CTC version 3.0 and radiotherapy toxicities are graded using the RTOG/EORTC Radiation Morbidity Scoring Schema.

Trial Locations

Locations (1)

Department of Radiation Oncology, Cancer Hospital, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC); 🇨🇳 Beijing, China