Rectal CancerNCT03541304
High Dose Radiotherapy for the Treatment of Rectal Cancer
An observational study of Rectal Cancer, run by Sun Yat-sen University at 1 site in China.
Trial summary
While surgery remains the standard treatment for rectal cancer, some patients still firmly refuse surgery for various reasons. Here, we conducted this retrospective observation study to discuss the feasibility of high-dose radiotherapy combined with chemotherapy in treating rectal cancer We retrospectively collect… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Rectal Cancer
- How many people
- 48 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2017to 16 Dec 2021
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This retrospective study included subjects identified from the database of the Sun Yat-sen University Cancer Center in the period of April 2006 to July 2017.
Who may be able to join
- pathologically confirmed diagnosis of rectal adenocarcinoma located within 15cm from the anal verge;
- pelvic radiation with a total dose ≥60Gy for the treatment of rectal cancer;
- refused surgery as the initial treatment;
- a complete set of clinical information and follow-up data.
Who cannot join
- patients with terminal cancer who received palliative treatment;
- patients received any treatment before admission to Sun Yat-sen University Cancer Center;
- patients with second primary cancer.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Toxicity of High Dose Radiotherapy Wich Concurrent Chemotherapy for the Treatment of Rectal Cancer
While surgery remains the standard treatment for rectal cancer, some patients still firmly refuse surgery for various reasons. Here, we conducted this retrospective observation study to discuss the feasibility of high-dose radiotherapy combined with chemotherapy in treating rectal cancer We retrospectively collect data of rectal cancer patients who were treated with high-dose radiotherapy plus chemotherapy in Sun Yat-sen University Cancer Center from April 1st, 2006 to July 30th, 2017. Patients gave up surgery before any treatment would have received one course of high dose radiotherapy (GTV60-70Gy/30-35f). Patients with tumor residual after neoadjuvant chemoradiotherapy but insisted non-operative treatment would have received 2 courses of radiotherapy (1st: GTV 45-50Gy/25f, 2nd: GTV 30/15f). The chemotherapy regimens included Capox, FOLFOX, or capecitabine at the discretion of the treating physician.
After treatment, patients were followed every 3 months for the first two years, at least every 6 months in the year thereafter. Recurrence, early and late toxicity were recorded.
Analyses were performed using SPSS software, version 19.0 (SPSS, Chicago, IL). Local recurrence and distant metastasis rate, progression free survival, and overall survival were calculated using the Kaplan Meier Method and were compared by log-rank test.
- Conditions
- Rectal Cancer
- Keywords
- high dose radiotherapy, rectal cancer
- Medical subject headings
- Rectal Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical response rate
the rate of clinical response in the whole group
Measured: evaluate 5 weeks after radiotherapy
Secondary outcomes (3)
short term and long term side effects
short term and long term toxicity related to high dose radiotherapy
Measured: from the complete to 3 years after treatment
progression free survival
defined as the time from the date of trial entry until disease progression, relapse, or death from any cause.
Measured: 3 years
overall survival
calculated from the date of trial entry until death from any cause or was censored at last follow-up
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2018
- Study start1 Jan 2017
- Primary completion16 Mar 2019
- Study completion16 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yuan-hong Gao, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03541304
- Sponsor's protocol ID
- 2018-FXY-079
- Status last verified
- Apr 2023
- First submitted
- 18 May 2018
- Last updated
- 14 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Toxicity of High Dose Radiotherapy Wich Concurrent Chemotherapy for the Treatment of Rectal Cancer
- ClinicalTrials.gov ID
- NCT03541304
- Acronym / sponsor ID
- 2018-FXY-079
- Conditions
- Rectal Cancer
- Keywords
- high dose radiotherapy, rectal cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 16 Mar 2019 (actual)
- Study completion
- 16 Dec 2021 (actual)
- First posted
- 30 May 2018 (actual)
- 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.
While surgery remains the standard treatment for rectal cancer, some patients still firmly refuse surgery for various reasons. Here, we conducted this retrospective observation study to discuss the feasibility of high-dose radiotherapy combined with chemotherapy in treating rectal cancer We retrospectively collect data of rectal cancer patients who were treated with high-dose radiotherapy plus chemotherapy in Sun Yat-sen University Cancer Center from April 1st, 2006 to July 30th, 2017. Patients gave up surgery before any treatment would have received one course of high dose radiotherapy (GTV60-70Gy/30-35f). Patients with tumor residual after neoadjuvant chemoradiotherapy but insisted non-operative treatment would have received 2 courses of radiotherapy (1st: GTV 45-50Gy/25f, 2nd: GTV 30/15f). The chemotherapy regimens included Capox, FOLFOX, or capecitabine at the discretion of the treating physician.
After treatment, patients were followed every 3 months for the first two years, at least every 6 months in the year thereafter. Recurrence, early and late toxicity were recorded.
Analyses were performed using SPSS software, version 19.0 (SPSS, Chicago, IL). Local recurrence and distant metastasis rate, progression free survival, and overall survival were calculated using the Kaplan Meier Method and were compared by log-rank test.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This retrospective study included subjects identified from the database of the Sun Yat-sen University Cancer Center in the period of April 2006 to July 2017.
Key inclusion criteria (4 listed)
- pathologically confirmed diagnosis of rectal adenocarcinoma located within 15cm from the anal verge;
- pelvic radiation with a total dose ≥60Gy for the treatment of rectal cancer;
- refused surgery as the initial treatment;
- a complete set of clinical information and follow-up data.
Key exclusion criteria (3 listed)
- patients with terminal cancer who received palliative treatment;
- patients received any treatment before admission to Sun Yat-sen University Cancer Center;
- patients with second primary cancer.
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
clinical response rate
Time frame: evaluate 5 weeks after radiotherapy
the rate of clinical response in the whole group
3 secondary outcomes
short term and long term side effects
Time frame: from the complete to 3 years after treatment
progression free survival
Time frame: 3 years
overall survival
Time frame: 3 years
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 14 Apr 2023.
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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, run by Sun Yat-sen University 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 3 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 14 Apr 2023. 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?
clinical response rate (time frame: evaluate 5 weeks after radiotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Apr 2023.