Observational Study on the Patients With Rectal Cancer

NCT ID: NCT02312284

Last Updated: 2016-01-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

3995 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-01-31

Study Completion Date

2014-11-30

Brief Summary

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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

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Conditions

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Rectal Cancer Adjuvant Chemoradiotherapy Neoadjuvant Chemoradiotherapy Adjuvant Chemotherapy Surgery

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Radiotherapy/Chemoradiotherapy

Pre- or postoperative or palliative radiotherapy/chemoradiotherapy based on 5-fluorouracil or Capecitabine +/-Oxaliplatin

No interventions assigned to this group

Surgery

Transabdominal resection or transanal excision

No interventions assigned to this group

Chemotherapy

Pre- or postoperative chemotherapy including 5-fluorouracil/leucovorin with oxaliplatin, Capecitabine, etc

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese Academy of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Jing Jin, M.D.

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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

Beijing, , China

Site Status

Countries

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China

References

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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.

Reference Type DERIVED
PMID: 29968240 (View on PubMed)

Other Identifiers

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CAMS 14-122/912

Identifier Type: -

Identifier Source: org_study_id

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