Observational Study on the Patients With Rectal Cancer

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

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).

Study Overview

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

• Study Type: Observational
• Enrollment (Actual): 3995

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100021
    • Department of Radiation Oncology, Cancer Hospital, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Clinical, pathological and routine laboratory characteristics for 3995 patients were extracted from 5097 patients with rectal cancer treated in Cancer Hospital, Chinese Academy of Medical Sciences from 2000 to 2010.The clinical data were reviewed and a prediction nomogram based on the Cox proportional hazards model were developed.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Radiotherapy/Chemoradiotherapy; Pre- or postoperative or palliative radiotherapy/chemoradiotherapy based on 5-fluorouracil or Capecitabine +/-Oxaliplatin
Surgery; Transabdominal resection or transanal excision
Chemotherapy; Pre- or postoperative chemotherapy including 5-fluorouracil/leucovorin with oxaliplatin, Capecitabine, etc

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Publications and helpful links

General Publications

• Liu W, Jin J, Li Y, Wang S, Song Y, Liu Y, Wang W, Ren H, Fang H, Li N, Tang Y, Wang X, Tang Y, Lu N, Xiao Q, Feng Y, Wang J, Deng L, Jing H, Liu X, Yu Z. [Radical surgery combined with adjuvant radiotherapy for elderly patients aged over 75 years with stage II( or III( rectal cancer: a retrospective study from a single center]. Zhonghua Wei Chang Wai Ke Za Zhi. 2018 Jun 25;21(6):654-659. Chinese.

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): November 1, 2014
• Study Completion (Actual): November 1, 2014

Study Registration Dates

• First Submitted: December 4, 2014
• First Submitted That Met QC Criteria: December 6, 2014
• First Posted (Estimate): December 9, 2014

Study Record Updates

• Last Update Posted (Estimate): January 18, 2016
• Last Update Submitted That Met QC Criteria: January 14, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Rectal Neoplasms
• Other Study ID Numbers: CAMS 14-122/912