NCT02312284

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,995

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 4, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 9, 2014

Completed
Last Updated

January 18, 2016

Status Verified

January 1, 2016

Enrollment Period

3.8 years

First QC Date

December 4, 2014

Last Update Submit

January 14, 2016

Conditions

Rectal CancerAdjuvant ChemoradiotherapyNeoadjuvant ChemoradiotherapyAdjuvant ChemotherapySurgery

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (2)

  • 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

  • Surgery complication

    within 30 days after surgery

Study Arms (3)

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Beijing, 100021, China

Location

Related Publications (1)

  • 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.

    PMID: 29968240DERIVED

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

December 4, 2014

First Posted

December 9, 2014

Study Start

January 1, 2011

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

January 18, 2016

Record last verified: 2016-01

Locations

CN(1)