Rectal TumorsNCT03258541
Organ-sparing With TraceIT® for Rectal Cancer Radiotherapy
A study testing TraceIT®, Volumetric Arc Therapy (VMAT) and Surgery in people with Rectal Tumors and Rectal Cancer, run by Thomas Zilli at 1 site in Switzerland.
Trial summary
For advanced rectal tumors, the standard of care is neoadjuvant radiotherapy (RT) +/- chemotherapy followed by surgery 8-10 weeks later. Despite its proven efficacy in reducing local relapse, the neo-adjuvant treatment has been associated to non-negligible side effects, especially in terms of impaired sexual function. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Rectal Tumors, Rectal Cancer, Advanced Cancer
- What is being tested?
- TraceIT®, Volumetric Arc Therapy (VMAT) and Surgery
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 2 participants
- Where
- 1 siteSwitzerland
- Study dates
- 15 Jan 2017to May 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- WHO (World Health Organization) performance status 0-1 at registration
- Locally advanced (T1-2 node positive or T3 N0/N+) histologically proven rectal adenocarcinoma located in the middle or in the high rectum. Patients with tumors located in the lower rectum may be eligible if the location of the tumor do not preclude the implant of the spacer (i.e. tumors located anteriorly in the proximity of the anal sphincter)
- Indication for preoperative radiotherapy or radio-chemotherapy
- Absence of any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
- Before patient registration/randomization, written informed consent must be given according to GCP/ICH (Guideline for Good Clinical Practice/Harmonised Tripartite Guideline), and national/local regulations.
Who cannot join
- Patient <18 years old
- WHO performance status ≥ 2 at registration
- Patient with a local extension, clinical stage T4 and/or presenting a vagina/prostate/bladder invasion
- Active bleeding disorder or clinically significant coagulopathy (PTT >35sec/ or INR >1.4 (INR, international normalized ratio). Or platelet count < 100'000/mm3)
- Active inflammatory or infectious process involving the perineum, gastrointestinal or urinary tract
- Compromised immune system (e.g. HIV/acquired immunodeficiency syndrome, autoimmune disease or immunosuppressive therapy)
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- History of previous pelvic surgery
- History of active inflammatory bowel disease (Crohn's disease, ulcerative colitis, irritable bowel disease)
- Contraindication for MRI
- Pregnant or lactating females
- Inability to provide a written informed consent
- Inability to comply with study and follow up procedures
Trial locations and contacts
1 site in 1 country.
About this study
Official title: TraceIT® Hydrogel Spacer Injections for Vagina and Erectile Bundles Sparing in Rectal Cancer Patients Treated With Neoadjuvant Radiotherapy: a Feasibility Study
For advanced rectal tumors, the standard of care is neoadjuvant radiotherapy (RT) +/- chemotherapy followed by surgery 8-10 weeks later. Despite its proven efficacy in reducing local relapse, the neo-adjuvant treatment has been associated to non-negligible side effects, especially in terms of impaired sexual function. For females, pelvic RT is frequently associated to long-term complications such as vaginal stenosis (VS), vaginal dryness, and dyspareunia, while in men RT doses delivered to the neurovascular peri-prostatic bundles and penile bulb have been associated to the risk to develop erectile dysfunction.
In prostate cancer, hydrogel spacers have been evaluated to create space between the target (prostate) and the organ (rectum) to be spared during radiotherapy treatments. Clinical studies have shown the ease of spacer application; patient tolerance and, good clinical outcomes (decrease in rectal toxicities).
This pilot study wishes to investigate feasibility and efficacy of the injected hydrogel spacers TraceIT® in sparing vagina/prostate in the treatment of rectal cancer patients.
Read the detailed description
This is a feasibility prospective pilot study. Ten patients (5 males and 5 females) with a histologically proven locally advanced rectal cancer with the indication of neoadjuvant radiotherapy or radio-chemotherapy will be recruited for this study. Prior to enrollment, potential candidates will undergo a thorough physical and clinical examination and documentation on medical and surgical history. If eligible, a baseline planning computed tomography (CT) simulation will be performed at the Radiation Oncology Department before the TraceIT® implant. Participants will undergo a transperineal injection of TraceIT® spacer gel between rectum and vagina or prostate performed by a trained radiologist under transrectal ultrasound guidance. A CT simulation will be repeated within 3 to 5 days post injection using the same imaging modality and treatment position used the pre- TraceIT® injection. Radiation treatment plans will be generated using scans realized pre- and post- TraceIT® injection and compared using dose volume histograms (DVH) analyses. Tolerance, side effects, and adverse events related to the procedure will be recorded prospectively from the injection until week-4 after EBRT (External Beam Radiation Therapy) completion. Radiological status of the spacer will be evaluated on the preoperative magnetic resonance Imaging (MRI). Histopathological results and any serious and/or unanticipated adverse events following surgery procedure will be recorded retrospectively.
- Conditions
- Rectal Tumors, Rectal Cancer, Advanced Cancer
- Being tested
- TraceIT®, Volumetric Arc Therapy (VMAT), Surgery
- Keywords
- TraceIT®, Hydrogel spacer, Rectal cancer
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TraceIT®Device
This pilot study wishes to investigate feasibility and efficacy of the injected hydrogel spacers TraceIT® in sparing vagina/prostate in the treatment of rectal cancer patients.
Volumetric Arc Therapy (VMAT)Radiation
VMAT - fractionation Schedule : 1.8 Gy per fraction, one fraction per day, 5 fractions per week for the elective PTV and 2 Gy per fraction, one fraction per day, 5 fractions per week for the PTV-boost using a simultaneous integrated boost technique.
SurgeryProcedure or surgery
Low anterior resection of the rectum: 8-10 weeks post-radiotherapy
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical performance
Incidence of serious adverse events.
Measured: 2 years
Secondary outcomes (1)
Comparative dosimetric studies
Dosimetric parameters to determine effectiveness of this technique to reduce RT (radiotherapy) doses to the vagina/erectile bundles as assessed by comparative dosimetric studies.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2017
- Study start15 Jan 2017
- Primary completionMay 2020
- Study completionMay 2020
Why it stopped: Surgical access not facilitated- residues of hydrogel.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal TumorsStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas Zilli
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Geneva
- Responsible party
- Sponsor-investigator, Thomas Zilli, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03258541
- Sponsor's protocol ID
- TraceIT_01268
- Status last verified
- May 2020
- First submitted
- 17 May 2017
- Last updated
- 15 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TraceIT® Hydrogel Spacer Injections for Vagina and Erectile Bundles Sparing in Rectal Cancer Patients Treated With Neoadjuvant Radiotherapy: a Feasibility Study
- ClinicalTrials.gov ID
- NCT03258541
- Acronym / sponsor ID
- TraceIT_01268
- Conditions
- Rectal Tumors, Rectal Cancer, Advanced Cancer
- Keywords
- TraceIT®, Hydrogel spacer, Rectal cancer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Surgical access not facilitated- residues of hydrogel.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Thomas ZilliUniversity, hospital or other
- Collaborators
- University Hospital, Geneva
- Study start
- 15 Jan 2017 (actual)
- Primary completion
- May 2020 (actual)
- Study completion
- May 2020 (actual)
- First posted
- 23 Aug 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.
For advanced rectal tumors, the standard of care is neoadjuvant radiotherapy (RT) +/- chemotherapy followed by surgery 8-10 weeks later. Despite its proven efficacy in reducing local relapse, the neo-adjuvant treatment has been associated to non-negligible side effects, especially in terms of impaired sexual function. For females, pelvic RT is frequently associated to long-term complications such as vaginal stenosis (VS), vaginal dryness, and dyspareunia, while in men RT doses delivered to the neurovascular peri-prostatic bundles and penile bulb have been associated to the risk to develop erectile dysfunction.
In prostate cancer, hydrogel spacers have been evaluated to create space between the target (prostate) and the organ (rectum) to be spared during radiotherapy treatments. Clinical studies have shown the ease of spacer application; patient tolerance and, good clinical outcomes (decrease in rectal toxicities).
This pilot study wishes to investigate feasibility and efficacy of the injected hydrogel spacers TraceIT® in sparing vagina/prostate in the treatment of rectal cancer patients.
Detailed description
This is a feasibility prospective pilot study. Ten patients (5 males and 5 females) with a histologically proven locally advanced rectal cancer with the indication of neoadjuvant radiotherapy or radio-chemotherapy will be recruited for this study. Prior to enrollment, potential candidates will undergo a thorough physical and clinical examination and documentation on medical and surgical history. If eligible, a baseline planning computed tomography (CT) simulation will be performed at the Radiation Oncology Department before the TraceIT® implant. Participants will undergo a transperineal injection of TraceIT® spacer gel between rectum and vagina or prostate performed by a trained radiologist under transrectal ultrasound guidance. A CT simulation will be repeated within 3 to 5 days post injection using the same imaging modality and treatment position used the pre- TraceIT® injection. Radiation treatment plans will be generated using scans realized pre- and post- TraceIT® injection and compared using dose volume histograms (DVH) analyses. Tolerance, side effects, and adverse events related to the procedure will be recorded prospectively from the injection until week-4 after EBRT (External Beam Radiation Therapy) completion. Radiological status of the spacer will be evaluated on the preoperative magnetic resonance Imaging (MRI). Histopathological results and any serious and/or unanticipated adverse events following surgery procedure will be recorded retrospectively.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- WHO (World Health Organization) performance status 0-1 at registration
- Locally advanced (T1-2 node positive or T3 N0/N+) histologically proven rectal adenocarcinoma located in the middle or in the high rectum. Patients with tumors located in the lower rectum may be eligible if the location of the tumor do not preclude the implant of the spacer (i.e. tumors located anteriorly in the proximity of the anal sphincter)
- Indication for preoperative radiotherapy or radio-chemotherapy
- Absence of any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
- Before patient registration/randomization, written informed consent must be given according to GCP/ICH (Guideline for Good Clinical Practice/Harmonised Tripartite Guideline), and national/local regulations.
Key exclusion criteria (12 listed)
- Patient <18 years old
- WHO performance status ≥ 2 at registration
- Patient with a local extension, clinical stage T4 and/or presenting a vagina/prostate/bladder invasion
- Active bleeding disorder or clinically significant coagulopathy (PTT >35sec/ or INR >1.4 (INR, international normalized ratio). Or platelet count < 100'000/mm3)
- Active inflammatory or infectious process involving the perineum, gastrointestinal or urinary tract
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 |
|---|---|---|
| TraceIT®This pilot study wishes to investigate feasibility and efficacy of the injected hydrogel spacers TraceIT® in sparing vagina/prostate in the treatment of rectal cancer patients. | Device | – |
| Volumetric Arc Therapy (VMAT)VMAT - fractionation Schedule : 1.8 Gy per fraction, one fraction per day, 5 fractions per week for the elective PTV and 2 Gy per fraction, one fraction per day, 5 fractions per week for the PTV-boost using a simultaneous integrated boost technique. | Radiation | – |
| SurgeryLow anterior resection of the rectum: 8-10 weeks post-radiotherapy | Procedure or surgery | – |
Primary outcome
Clinical performance
Time frame: 2 years
Incidence of serious adverse events.
1 secondary outcome
Comparative dosimetric studies
Time frame: 2 years
Results and safety
The study was stopped early (reason given: Surgical access not facilitated- residues of hydrogel.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2020.
- Individual participant dataSharing planned: No
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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?
A study testing TraceIT®, Volumetric Arc Therapy (VMAT) and Surgery in people with Rectal Tumors and Rectal Cancer, run by Thomas Zilli at 1 site in Switzerland.
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 12 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: stopped early, as of the sponsor's last update on 15 May 2020. 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 Switzerland. 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 was stopped early (reason given: Surgical access not facilitated- residues of hydrogel.). Results are not available in the source record.
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 performance (time frame: 2 years). 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 15 May 2020.