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Observational Study on the Patients With Rectal Cancer

Sponsor
Chinese Academy of Medical Sciences (Other)
Overall Status
Completed
CT.gov ID
NCT02312284
Collaborator
(none)
3,995
Enrollment
1
Location
46
Duration (Months)
86.9
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    3995 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Observational Study on the Patients With Rectal Cancer: Experience From Cancer Hospital, Chinese Academy of Medical Sciences 2000-2010
    Study Start Date :
    Jan 1, 2011
    Actual Primary Completion Date :
    Nov 1, 2014
    Actual Study Completion Date :
    Nov 1, 2014

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Outcome Measures

    Primary Outcome Measures

    1. Overall survival [5-10 years]

    2. Cancer-specific survival [5-10 years]

    3. Locoregional recurrence free survival [5-10 years]

    4. Distant metastasis free survival [5-10 years]

    Secondary Outcome Measures

    1. 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.

    2. Surgery complication [within 30 days after surgery]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Radiation Oncology, Cancer Hospital, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC) Beijing China 100021

    Sponsors and Collaborators

    • Chinese Academy of Medical Sciences

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jing Jin, M.D., MD, Chinese Academy of Medical Sciences
    ClinicalTrials.gov Identifier:
    NCT02312284
    Other Study ID Numbers:
    • CAMS 14-122/912
    First Posted:
    Dec 9, 2014
    Last Update Posted:
    Jan 18, 2016
    Last Verified:
    Jan 1, 2016
    Additional relevant MeSH terms:
    Rectal Neoplasms

    Study Results

    No Results Posted as of Jan 18, 2016