Organ-sparing With TraceIT® for Rectal Cancer Radiotherapy

NCT03258541 | Terminated DMC FDA Device

• 1 other identifier: TraceIT_01268
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Rectal Tumors; Rectal Cancer; Advanced Cancer

Keywords

TraceIT®; Hydrogel spacer; Rectal cancer

Outcome Measures

Primary Outcomes (1)

• Clinical performance

  Incidence of serious adverse events.

  2 years

Secondary Outcomes (1)

• Comparative dosimetric studies

  2 years

Interventions

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.

Surgery PROCEDURE

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

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Thomas Zilli: lead
• University Hospital, Geneva: collaborator

Study Sites (1)

University Hospital of Geneva

Geneva, 1205, Switzerland

Location

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Radiotherapy, Intensity-Modulated; Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, PD, Médecin adjoint agrégé

Study Record Dates

• First Submitted: May 17, 2017
• First Posted: August 23, 2017
• Study Start: January 15, 2017
• Primary Completion: May 1, 2020
• Study Completion: May 1, 2020
• Last Updated: May 15, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)