Observational Study on the Patients With Rectal Cancer

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02312284
• Other study ID #: CAMS 14-122/912
• Status: Completed
• Phase: N/A
• First received: December 4, 2014
• Last updated: January 14, 2016
• Start date: January 2011
• Est. completion date: November 2014

Study information

• Verified date: January 2016
• Source: Chinese Academy of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3995
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adjuvant Chemoradiotherapy
• Adjuvant Chemotherapy
• Neoadjuvant Chemoradiotherapy
• Rectal Cancer
• Rectal Neoplasms
• Surgery

Locations

Country	Name	City	State
China	Department of Radiation Oncology, Cancer Hospital, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC)	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese Academy of Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival		5-10 years
Primary	Cancer-specific survival		5-10 years
Primary	Locoregional recurrence free survival		5-10 years
Primary	Distant metastasis free survival		5-10 years
Secondary	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
Secondary	Surgery complication		within 30 days after surgery