Rectal CancerNCT02312284
Observational Study on the Patients With Rectal Cancer
An observational study of Rectal Cancer and Adjuvant Chemoradiotherapy, run by Chinese Academy of Medical Sciences at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Cancer, Adjuvant Chemoradiotherapy, Neoadjuvant Chemoradiotherapy
- How many people
- 3,995 participants
- Where
- 1 siteChina
- Study dates
- Jan 2011to Nov 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Radiation Oncology, Cancer Hospital, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC)
Beijing, 100021
About this study
Official title: Observational Study on the Patients With Rectal Cancer: Experience From Cancer Hospital, Chinese Academy of Medical Sciences 2000-2010
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).
- Conditions
- Rectal Cancer, Adjuvant Chemoradiotherapy, Neoadjuvant Chemoradiotherapy, Adjuvant Chemotherapy, Surgery
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Measured: 5-10 years
Cancer-specific survival
Measured: 5-10 years
Locoregional recurrence free survival
Measured: 5-10 years
Distant metastasis free survival
Measured: 5-10 years
Secondary outcomes (2)
Chemotherapy/Radiotherapy/Chemoradiotherapy toxicities
Chemotherapy toxicities are evaluated by NCI-CTC version 3.0 and radiotherapy toxicities are graded using the RTOG/EORTC Radiation Morbidity Scoring Schema.
Measured: 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
Measured: within 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2014 (estimated)
- Study startJan 2011
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 3,995 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jing Jin, M.D., Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02312284
- Sponsor's protocol ID
- CAMS 14-122/912
- Status last verified
- Jan 2016
- First submitted
- 4 Dec 2014
- Last updated
- 18 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 29968240
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study on the Patients With Rectal Cancer: Experience From Cancer Hospital, Chinese Academy of Medical Sciences 2000-2010
- ClinicalTrials.gov ID
- NCT02312284
- Acronym / sponsor ID
- CAMS 14-122/912
- Conditions
- Rectal Cancer, Adjuvant Chemoradiotherapy, Neoadjuvant Chemoradiotherapy, Adjuvant Chemotherapy, Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,995 participants (actual)
- Lead sponsor
- Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 9 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overall survival
Time frame: 5-10 years
Cancer-specific survival
Time frame: 5-10 years
Locoregional recurrence free survival
Time frame: 5-10 years
Distant metastasis free survival
Time frame: 5-10 years
2 secondary outcomes
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
Surgery complication
Time frame: within 30 days after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2016.
- Derived from this study: PubMed 29968240Liu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rectal Cancer and Adjuvant Chemoradiotherapy, run by Chinese Academy of Medical Sciences at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: 5-10 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02312284, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2016.