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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02312284

Enrollment

3995

Registered

2014-12-09

Start date

2011-01-31

Completion date

2014-11-30

Last updated

2016-01-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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).

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Measure	Time frame	Description
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.
Surgery complication	within 30 days after surgery	—

Countries

China

Outcome results