Observational Study on the Patients With Rectal Cancer

Study Overview
=================
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).

Official Title
-----------------
Observational Study on the Patients With Rectal Cancer: Experience From Cancer Hospital, Chinese Academy of Medical Sciences 2000-2010

Conditions
-----------------
Rectal Cancer, Adjuvant Chemoradiotherapy, Neoadjuvant Chemoradiotherapy, Adjuvant Chemotherapy, Surgery

Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Radiotherapy/Chemoradiotherapy<br>Pre- or postoperative or palliative radiotherapy/chemoradiotherapy based on 5-fluorouracil or Capecitabine +/-Oxaliplatin | |
| Surgery<br>Transabdominal resection or transanal excision | |
| Chemotherapy<br>Pre- or postoperative chemotherapy including 5-fluorouracil/leucovorin with oxaliplatin, Capecitabine, etc | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | 5-10 years | 
| Cancer-specific survival |  | 5-10 years | 
| Locoregional recurrence free survival |  | 5-10 years | 
| Distant metastasis free survival |  | 5-10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chemotherapy/Radiotherapy/Chemoradiotherapy toxicities | Chemotherapy toxicities are evaluated by NCI-CTC version 3.0 and radiotherapy toxicities are graded using the RTOG/EORTC Radiation Morbidity Scoring Schema. | 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 | 
| Surgery complication |  | within 30 days after surgery |