Status:
TERMINATED
Organ-sparing With TraceIT® for Rectal Cancer Radiotherapy
Lead Sponsor:
Thomas Zilli
Collaborating Sponsors:
University Hospital, Geneva
Conditions:
Rectal Tumors
Rectal Cancer
Eligibility:
All Genders
18-85 years
Phase:
NA
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-...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 15 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2020
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT03258541
Start Date
January 15 2017
End Date
May 1 2020
Last Update
May 15 2020
Active Locations (1)
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1
University Hospital of Geneva
Geneva, Switzerland, 1205