Rectal Cancer Clinical Trial
Official title:
TraceIT® Hydrogel Spacer Injections for Vagina and Erectile Bundles Sparing in Rectal Cancer Patients Treated With Neoadjuvant Radiotherapy: a Feasibility Study
Verified date | May 2020 |
Source | University Hospital, Geneva |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 2 |
Est. completion date | May 2020 |
Est. primary completion date | May 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Switzerland | University Hospital of Geneva | Genève |
Lead Sponsor | Collaborator |
---|---|
Thomas Zilli | University Hospital, Geneva |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Clinical performance | Incidence of serious adverse events. | 2 years | |
Secondary | 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. | 2 years |
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