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Organ-sparing With TraceIT® for Rectal Cancer Radiotherapy

Primary Purpose

Rectal Tumors, Rectal Cancer, Advanced Cancer

Status

Terminated

Phase

Not Applicable

Locations

Switzerland

Study Type

Interventional

Intervention

TraceIT®

Volumetric Arc Therapy (VMAT)

Surgery

About this trial

This is an interventional treatment trial for Rectal Tumors focused on measuring TraceIT®, Hydrogel spacer, Rectal cancer

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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)
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

Sites / Locations

University Hospital of Geneva

Outcomes

Primary Outcome Measures

Clinical performance

Incidence of serious adverse events.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT03258541

First Posted

May 17, 2017

Last Updated

May 13, 2020

Sponsor

Thomas Zilli

Collaborators

University Hospital, Geneva

1. Study Identification

Unique Protocol Identification Number

NCT03258541

Brief Title

Organ-sparing With TraceIT® for Rectal Cancer Radiotherapy

Official Title

TraceIT® Hydrogel Spacer Injections for Vagina and Erectile Bundles Sparing in Rectal Cancer Patients Treated With Neoadjuvant Radiotherapy: a Feasibility Study

Study Type

Interventional

2. Study Status

Record Verification Date

May 2020

Overall Recruitment Status

Terminated

Why Stopped

Surgical access not facilitated- residues of hydrogel.

Study Start Date

January 15, 2017 (Actual)

Primary Completion Date

May 2020 (Actual)

Study Completion Date

May 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Thomas Zilli

Collaborators

University Hospital, Geneva

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rectal Tumors, Rectal Cancer, Advanced Cancer

Keywords

TraceIT®, Hydrogel spacer, Rectal cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

2 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Device

Intervention Name(s)

TraceIT®

Intervention Description

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.

Intervention Type

Radiation

Intervention Name(s)

Volumetric Arc Therapy (VMAT)

Intervention Description

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.

Intervention Type

Procedure

Intervention Name(s)

Surgery

Intervention Description

Low anterior resection of the rectum: 8-10 weeks post-radiotherapy

Primary Outcome Measure Information:

Title

Clinical performance

Description

Incidence of serious adverse events.

Time Frame

2 years

Secondary Outcome Measure Information:

Title

Comparative dosimetric studies

Description

Dosimetric parameters to determine effectiveness of this technique to reduce RT (radiotherapy) doses to the vagina/erectile bundles as assessed by comparative dosimetric studies.

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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) 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

Facility Information:

Facility Name

University Hospital of Geneva

City

Genève

ZIP/Postal Code

1205

Country

Switzerland

12. IPD Sharing Statement

Plan to Share IPD

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Organ-sparing With TraceIT® for Rectal Cancer Radiotherapy

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