Clinical trial NCT02312284: Observational Study on the Patients With Rectal Cancer
Official title: Observational Study on the Patients With Rectal Cancer: Experience From Cancer Hospital, Chinese Academy of Medical Sciences 2000-2010
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rectal Cancer
Adjuvant Chemoradiotherapy
Neoadjuvant Chemoradiotherapy
Adjuvant Chemotherapy
Surgery
Lead sponsor: ChineseAMS
Sponsor class: UNKNOWN
First posted: 2014-12-09
Enrollment: 3995
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_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.

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).


Eligibility criteria: 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

Primary outcomes:
measure: Overall survival
timeFrame: 5-10 years
measure: Cancer-specific survival
timeFrame: 5-10 years
measure: Locoregional recurrence free survival
timeFrame: 5-10 years
measure: Distant metastasis free survival
timeFrame: 5-10 years
Secondary outcomes:
measure: Chemotherapy/Radiotherapy/Chemoradiotherapy toxicities
timeFrame: 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
measure: Surgery complication
timeFrame: within 30 days after surgery
Other outcomes:
Locations:
city: Beijing
country: China
facility: Department of Radiation Oncology, Cancer Hospital, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC)
Study officials:
References:
citation: 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.