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NCT Number: NCT02312284

Observational Study on the Patients With Rectal Cancer

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).

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Key information

Conditions

Rectal Cancer Adjuvant Chemoradiotherapy Adjuvant Chemotherapy Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoadjuvant Chemoradiotherapy Neoplasms Neoplasms by Site Rectal Diseases Rectal Neoplasms Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Beijing, 100021, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Overall survival

    Time frame: 5-10 years

  2. Cancer-specific survival

    Time frame: 5-10 years

  3. Locoregional recurrence free survival

    Time frame: 5-10 years

  4. Distant metastasis free survival

    Time frame: 5-10 years

Secondary outcomes

  1. Chemotherapy/Radiotherapy/Chemoradiotherapy toxicities

    Time frame: 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

    Time frame: within 30 days after surgery

Sponsors and collaborators

Lead sponsor

Chinese Academy of Medical Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Dec 9, 2014
Registry last updated
Jan 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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