Rectal CancerIROTNCT03209336
Study of Intraoperative Radiotherapy for Middle and Low Rectal Cancer
A study testing Intraoperative radiotherapy by Intrabeam（Zeiss Meditech，Jena，Germany） in people with Rectal Cancer, run by Second Hospital of Jilin University at 1 site in China.
Trial summary
To study the application of Intersphincteric Resection（ISR）combined with intraoperative radiation therapy(IORT) for ultra-low rectal cancer,and to broaden the surgical indications of Intersphincteric Resection（ISR. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- Intraoperative radiotherapy by Intrabeam（Zeiss Meditech，Jena，Germany）
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2015to 30 Dec 2020
- Phase
- Interventional
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 40 to 80 years old, gender not limited.
- Be diagnosed as colorectal cancer by coloscopy.
- Patients with middle and low rectal cancer,whose preoperative staging evaluation is T3 ,T4 or N+.
- Accept surgery and intraoperative radiotherapy.
- Signed informed consent
Who cannot join
- the patients whose preoperative evaluation is below T3 stage with middle and rectal cancer.
- Active internal bleeding (such as gastrointestinal bleeding), urogenital system, or have not cure of peptic ulcer in four weeks
- Severe liver and kidney dysfunction
- Intracranial tumor, suspicious aortic dissection, arteriovenous malformation, aneurysm
- Thrombolysis treatment in one week
- Allergies of thrombolysis drug or contrast
- Participated in any clinical trials within three months
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Second Hospital of Jilin University
Changchun, Jilin, 130041
Min Wang, M.D., +86 13074373336, jdeywangmin@163.com
About this study
Official title: Single Center Study of Intraoperative Radiotherapy for Middle and Low Rectal Cancer in the Standard of Peritoneal Inversion Rectal Cancer.
To study the application of Intersphincteric Resection（ISR）combined with intraoperative radiation therapy(IORT) for ultra-low rectal cancer,and to broaden the surgical indications of Intersphincteric Resection（ISR.
The study is aimed to assess the postoperative acute complication and the short-term acute efficacy on the patients with middle and low rectal cancer by treated with intraoperative radiotherapy,especially those with peritoneal inversion rectal cancer.
Read the detailed description
Abstract objective: To study the application of Intersphincteric Resection（ISR）combined with intraoperative radiation therapy(IORT) for ultra-low rectal cancer,and to broaden the surgical indications of Intersphincteric Resection（ISR）.
Methods: Patients, who were diagnosed with ultra-low rectal cancer and had strong desire of preserving anal function, will take part in the research,whose tumor invading the levator ani muscle or above, the diameter less than 6cm, the lower tumor margin away from the anal verge by less than 5cm and away from the dentate line by less than 3cm.They will undergo total mesorectal excision(TME) and ISR combined with IORT and prophylactic ileostomy.
Outcomes Measures:The evaluation of short term effects includes complications such as anastomotic leakage, acute radiation injury ,urinary dysfunction ,dysfunction of anal sphincter ,sexual dysfunction ,local recurrence , total life expectancy and expectancy without metastasis. The postoperative pathological examination reported to be moderately differentiated adenocarcinoma .We wili assess their postoperative acute complications and short-term efficacy .Their time of follow up visit wil be 1 year or more.
- Conditions
- Rectal Cancer
- Being tested
- Intraoperative radiotherapy by Intrabeam（Zeiss Meditech，Jena，Germany）
- Keywords
- Ultra-low rectal cancer, Intersphincteric resection, IORT
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraoperative radiotherapy by Intrabeam（Zeiss Meditech，Jena，Germany）Radiation
We confirmed that if the patients had the distant metastasis before IORT. The median radiation dose was 5.00 Gy (range: 5.00-10.00Gy), the average dose was 6.00 Gy. The median radiation time was 0:33:24 (range: 0:21:45-1:06:23), which was the same with the patients'. All patients' surface dose ranged from 15.00 to 28.50 Gy.
| Study group | Role | What they receive |
|---|---|---|
| A group | Experimental | Colorectal cancer patients first are given antineoplastic drugs and then transfer to operative room to be treated by surgical resection and the radiotherapy is given during the operation after the removal of the tumour. Receives: Radiation: Intraoperative radiotherapy by Intrabeam（Zeiss Meditech，Jena，Germany） |
| B group | No intervention | Colorectal cancer patients first are given antineoplastic drugs and then transfer to operative room to be treated only by surgical resection and no radiotherapy afer the removal of the tumour. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decide and record the region of radiotherapy
The operator will confirm and record the range of intrabeam after removal of tumor such as the length and height to modify the dose and the time of intrabeam.
Measured: Intraoperation
The basic information and medical history achieved (questionnaire)
Investigators will take a overall information about the patients including the physical condition,history of present illness,family genetic history etc;Then the information will be recorded in a format to develop a statistic analysis.
Measured: baseline
Secondary outcomes (2)
Major Adverse Events
The local relapse (pelvic pain, bleeding and intestinal obstruction included)or metastasis will be recorded by the investigator
Measured: 1 year after operation
The short-term complications
The short-term complications(seroma,wound dehiscence and bleeding hematomas)will be followed up by investigator.
Measured: 1 year after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2017
- Study start1 Jan 2015
- Primary completion30 Dec 2020 (estimated)
- Study completion30 Dec 2020 (estimated)
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.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Hospital of Jilin University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03209336
- Sponsor's protocol ID
- SecondJilinU-IORT
- Acronym
- IROT
- Status last verified
- Jul 2017
- First submitted
- 30 Jun 2017
- Last updated
- 6 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: When the investigators complete the study and publish our data.
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Center Study of Intraoperative Radiotherapy for Middle and Low Rectal Cancer in the Standard of Peritoneal Inversion Rectal Cancer.
- ClinicalTrials.gov ID
- NCT03209336
- Acronym / sponsor ID
- IROT / SecondJilinU-IORT
- Conditions
- Rectal Cancer
- Keywords
- Ultra-low rectal cancer, Intersphincteric resection, IORT
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Second Hospital of Jilin UniversityUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 30 Dec 2020 (estimated)
- Study completion
- 30 Dec 2020 (estimated)
- First posted
- 6 Jul 2017 (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.
To study the application of Intersphincteric Resection（ISR）combined with intraoperative radiation therapy(IORT) for ultra-low rectal cancer,and to broaden the surgical indications of Intersphincteric Resection（ISR.
The study is aimed to assess the postoperative acute complication and the short-term acute efficacy on the patients with middle and low rectal cancer by treated with intraoperative radiotherapy,especially those with peritoneal inversion rectal cancer.
Detailed description
Abstract objective: To study the application of Intersphincteric Resection（ISR）combined with intraoperative radiation therapy(IORT) for ultra-low rectal cancer,and to broaden the surgical indications of Intersphincteric Resection（ISR）.
Methods: Patients, who were diagnosed with ultra-low rectal cancer and had strong desire of preserving anal function, will take part in the research,whose tumor invading the levator ani muscle or above, the diameter less than 6cm, the lower tumor margin away from the anal verge by less than 5cm and away from the dentate line by less than 3cm.They will undergo total mesorectal excision(TME) and ISR combined with IORT and prophylactic ileostomy.
Outcomes Measures:The evaluation of short term effects includes complications such as anastomotic leakage, acute radiation injury ,urinary dysfunction ,dysfunction of anal sphincter ,sexual dysfunction ,local recurrence , total life expectancy and expectancy without metastasis. The postoperative pathological examination reported to be moderately differentiated adenocarcinoma .We wili assess their postoperative acute complications and short-term efficacy .Their time of follow up visit wil be 1 year or more.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A group | Experimental | Radiation: Intraoperative radiotherapy by Intrabeam（Zeiss Meditech，Jena，Germany）Colorectal cancer patients first are given antineoplastic drugs and then transfer to operative room to be treated by surgical resection and the radiotherapy is given during the operation after the removal of the tumour. |
| B group | No intervention | –Colorectal cancer patients first are given antineoplastic drugs and then transfer to operative room to be treated only by surgical resection and no radiotherapy afer the removal of the tumour. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged 40 to 80 years old, gender not limited.
- Be diagnosed as colorectal cancer by coloscopy.
- Patients with middle and low rectal cancer,whose preoperative staging evaluation is T3 ,T4 or N+.
- Accept surgery and intraoperative radiotherapy.
- Signed informed consent
Key exclusion criteria (7 listed)
- the patients whose preoperative evaluation is below T3 stage with middle and rectal cancer.
- Active internal bleeding (such as gastrointestinal bleeding), urogenital system, or have not cure of peptic ulcer in four weeks
- Severe liver and kidney dysfunction
- Intracranial tumor, suspicious aortic dissection, arteriovenous malformation, aneurysm
- Thrombolysis treatment in one week
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intraoperative radiotherapy by Intrabeam（Zeiss Meditech，Jena，Germany）We confirmed that if the patients had the distant metastasis before IORT. The median radiation dose was 5.00 Gy (range: 5.00-10.00Gy), the average dose was 6.00 Gy. The median radiation time was 0:33:24 (range: 0:21:45-1:06:23), which was the same with the patients'. All patients' surface dose ranged from 15.00 to 28.50 Gy. | Radiation | A group |
Primary outcome
Decide and record the region of radiotherapy
Time frame: Intraoperation
The operator will confirm and record the range of intrabeam after removal of tumor such as the length and height to modify the dose and the time of intrabeam.
The basic information and medical history achieved (questionnaire)
Time frame: baseline
Investigators will take a overall information about the patients including the physical condition,history of present illness,family genetic history etc;Then the information will be recorded in a format to develop a statistic analysis.
2 secondary outcomes
Major Adverse Events
Time frame: 1 year after operation
The short-term complications
Time frame: 1 year after operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2017.
- Individual participant dataSharing planned: Yes. When the investigators complete the study and publish our data.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intraoperative radiotherapy by Intrabeam（Zeiss Meditech，Jena，Germany） in people with Rectal Cancer, run by Second Hospital of Jilin 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 5 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 6 Jul 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Min Wang, M.D. ((+86)13074373336, jdeywangmin@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decide and record the region of radiotherapy (time frame: Intraoperation). The study lists 2 primary outcomes in all. 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 6 Jul 2017.