Rectal CancerIDAVONNCT03393234
Intersphincteric Resection With or Without Intraoperative Radiation in Rectal Cancer
A study testing Interoperative radiation by INTRABEAM using low energy X-ray in people with Rectal Cancer, run by Second Hospital of Jilin University at 1 site in China.
Trial summary
The purpose of this study was to research on the safety and feasibility of ISR combined with low energy X ray intra-operative radiotherapy for the patients with local advanced rectal cancer. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- Interoperative radiation by INTRABEAM using low energy X-ray
- 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 Jun 2017to 1 Jan 2022
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- those whom were preoperatively assessed to be in clinical stageT3 or has lymphatic metastasis by MRI or ultrasonic endoscopy;
- the lower edge of the tumor is away from the anal edge by less than 5 cm, or away from the dentate line by less than 3cm;
- in intra-operative separation, the lower edge of the tumor is below the plane of the levator ani muscle or the tumor is hard to separate;
- those in T4 stage and could be radically resected by intra-operative surgeon assessment;
- adequate preoperative sphincter function and continence; (vi)local spread restricted to the rectal wall or the IAS.
- absence of distant metastases.
Who cannot join
- clinical T4 tumors based on the Union for International Cancer Control UICC TNM classification (7th edition):
- infiltrating gross appearance of the tumors;
- poorly differentiated adenocarcinoma by biopsy specimens;
- a degree of preoperative incontinence.
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: Study of Safety and Feasibility of the Intersphincteric Resection With or Without Intraoperative Radiation in Low Rectal Cancer
The purpose of this study was to research on the safety and feasibility of ISR combined with low energy X ray intra-operative radiotherapy for the patients with local advanced rectal cancer.
Read the detailed description
Inter-sphincteric resection (ISR) has become an increasingly popular optional surgical tool for the treatment of very low rectal cancer. Nowadays, preoperative criteria for Lap ISR were the patients whose diagnosed with clinical stages T1-2 and N0_1, which only a few patients with early stages can benefit from it. However, intra-operative radiotherapy with low energy X ray applied by Intrabeam is becoming an accepted radiotherapy technique for treatment of cancers. The purpose of this study was to research on the safety and feasibility of ISR combined with low energy X ray intra-operative radiotherapy for the patients with local advanced rectal cancer.
- Conditions
- Rectal Cancer
- Being tested
- Interoperative radiation by INTRABEAM using low energy X-ray
- 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.
Interoperative radiation by INTRABEAM using low energy X-rayRadiation
Intrabeam is a mobile Platform for Intraoperative Radiotherapy (IORT) produced by the ZEISS company in Germany.Interoperative radiation by INTRABEAM using low energy X-ray.The Intrabeam PRS appears to be a safe technique for delivering IORT in rectal cancer patients.
| Study group | Role | What they receive |
|---|---|---|
| A group | Experimental | Patients who receive interphincteric resection (ISR) in this group will be given extra intraoperative radiation by INTRBEAM using low energy X-ray. Receives: Radiation: Interoperative radiation by INTRABEAM using low energy X-ray |
| B group | No intervention | Patients who only receive interphincteric resection (ISR) in this group without intraoperative radiation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-year disease free survival
Compare 3-year disease free survival in patients with resectable rectal cancer treated with or without radiation.
Measured: 3 years
Secondary outcomes (6)
local recurrence rate
In our study, no matter whether distant metastases occurred, if there was the presence of any anastomotic, pelvic, or lateral node recurrences recorded by pathologic or clinical examination, we defined it as local recurrence.
Measured: 1 years
R0 resection rate
To calculate the radical resection rate.
Measured: 1 years
sphincter muscle function
Indicated by the anorectal manometry
Measured: 1 years
anorectal manometry
To measure the anus pressure to indirectly reflect the sphincter muscle function
Measured: 1 years
predictive biomarkers
Each follow-up, the biomarkers such as CEA,CA19-9 etc were recorded.
Measured: 3 years
sexual function
Investigated by the questionnaire including the International Index of Erectile dysfunction. (IIEF5)
Measured: 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2018
- Study start1 Jun 2017
- Primary completion1 Jan 2022 (estimated)
- Study completion1 Jan 2022 (estimated)
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- 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
- NCT03393234
- Sponsor's protocol ID
- ISR and IORT
- Acronym
- IDAVON
- Status last verified
- Jan 2018
- First submitted
- 1 Jan 2018
- Last updated
- 8 Jan 2018
- 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.
Publications
Wang M, Xue W, Zhao Z, Li Y, Wang X, Li T, Zou Y, Song X, Zhang M, Wang T, Yang J, Wang C, Wang S. Laparoscopic intersphincteric resection with intraoperative radiotherapy using low-energy X-rays for locally advanced ultra-low rectal cancer. World J Surg Oncol. 2018 Jul 7;16(1):133. doi: 10.1186/s12957-018-1430-6.
PubMed 29981575
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Safety and Feasibility of the Intersphincteric Resection With or Without Intraoperative Radiation in Low Rectal Cancer
- ClinicalTrials.gov ID
- NCT03393234
- Acronym / sponsor ID
- IDAVON / ISR and 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 Jun 2017 (actual)
- Primary completion
- 1 Jan 2022 (estimated)
- Study completion
- 1 Jan 2022 (estimated)
- First posted
- 8 Jan 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.
The purpose of this study was to research on the safety and feasibility of ISR combined with low energy X ray intra-operative radiotherapy for the patients with local advanced rectal cancer.
Detailed description
Inter-sphincteric resection (ISR) has become an increasingly popular optional surgical tool for the treatment of very low rectal cancer. Nowadays, preoperative criteria for Lap ISR were the patients whose diagnosed with clinical stages T1-2 and N0_1, which only a few patients with early stages can benefit from it. However, intra-operative radiotherapy with low energy X ray applied by Intrabeam is becoming an accepted radiotherapy technique for treatment of cancers. The purpose of this study was to research on the safety and feasibility of ISR combined with low energy X ray intra-operative radiotherapy for the patients with local advanced rectal cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A group | Experimental | Radiation: Interoperative radiation by INTRABEAM using low energy X-rayPatients who receive interphincteric resection (ISR) in this group will be given extra intraoperative radiation by INTRBEAM using low energy X-ray. |
| B group | No intervention | –Patients who only receive interphincteric resection (ISR) in this group without intraoperative radiation. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- those whom were preoperatively assessed to be in clinical stageT3 or has lymphatic metastasis by MRI or ultrasonic endoscopy;
- the lower edge of the tumor is away from the anal edge by less than 5 cm, or away from the dentate line by less than 3cm;
- in intra-operative separation, the lower edge of the tumor is below the plane of the levator ani muscle or the tumor is hard to separate;
- those in T4 stage and could be radically resected by intra-operative surgeon assessment;
- adequate preoperative sphincter function and continence; (vi)local spread restricted to the rectal wall or the IAS.
Key exclusion criteria (4 listed)
- clinical T4 tumors based on the Union for International Cancer Control UICC TNM classification (7th edition):
- infiltrating gross appearance of the tumors;
- poorly differentiated adenocarcinoma by biopsy specimens;
- a degree of preoperative incontinence.
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 |
|---|---|---|
| Interoperative radiation by INTRABEAM using low energy X-rayIntrabeam is a mobile Platform for Intraoperative Radiotherapy (IORT) produced by the ZEISS company in Germany.Interoperative radiation by INTRABEAM using low energy X-ray.The Intrabeam PRS appears to be a safe technique for delivering IORT in rectal cancer patients. | Radiation | A group |
Primary outcome
3-year disease free survival
Time frame: 3 years
Compare 3-year disease free survival in patients with resectable rectal cancer treated with or without radiation.
6 secondary outcomes
local recurrence rate
Time frame: 1 years
R0 resection rate
Time frame: 1 years
sphincter muscle function
Time frame: 1 years
anorectal manometry
Time frame: 1 years
predictive biomarkers
Time frame: 3 years
sexual function
Time frame: 1 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2018.
- Derived from this study: PubMed 29981575Wang M, Xue W, Zhao Z, Li Y, Wang X, Li T, Zou Y, Song X, Zhang M, Wang T, Yang J, Wang C, Wang S. Laparoscopic intersphincteric resection with intraoperative radiotherapy using low-energy X-rays for locally advanced ultra-low rectal cancer. World J Surg Oncol. 2018 Jul 7;16(1):133. doi: 10.1186/s12957-018-1430-6.
- 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 Interoperative radiation by INTRABEAM using low energy X-ray 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 6 inclusion and 4 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 8 Jan 2018. 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?
3-year disease free survival (time frame: 3 years). 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 NCT03393234, 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 8 Jan 2018; AzTrials last refreshed its copy on 6 Nov 2026.