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New treatment option for Tumor Recurrence
Official title Clinical Study on the Re-irradiation of Lateral Pelvic Recurrences of Gynecological Malignancies
ClinicalTrials.gov ID: NCT05457595
What this study is testing
- What it's testing
- The study aims to obtain a local control rate in patients with lateral pelvic relapses of gynecologycal cancers previously irradiated. High LET (Linear Energy Transfer) particles as carbon ions can guarantee a biologic advantage compared to photons in radioresistant neoplasms, given to their higher biological efficacy (RBE).
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- Patients ≥ 18 years of age
- Karnofsky Index ≥ 70
- Histological or radiological diagnosis of pelvic and groin recurrence
- Contraindications for radical surgery
- No other distant progression or stable disease (SD) of known secondarisms (≥6 months)
You likely can't join if
- Hip prosthesis, metal prostheses or any other condition that prevents adequate imaging to identify the target volume and calculate the dose in the...
- Intestinal infiltration
- Bladder infiltration
- Vessel infiltration
- Previous therapy with anti-angiogenesis drugs
- Psychic or other disorders that may prevent informed consent
See the full eligibility criteria
- Patients ≥ 18 years of age
- Karnofsky Index ≥ 70
- Histological or radiological diagnosis of pelvic and groin recurrence
- Contraindications for radical surgery
- No other distant progression or stable disease (SD) of known secondarisms (≥6 months)
- Previous radiation therapy on pelvis
- Distance ≥ 10mm between tumour and close intestinal tract (small intestine), radiologically evaluated
- Possibility to perform a surgery to space the intestinal loops, in case of distance \< 10mm
- If needed, spacer in biocompatible material (silicon, goretex) or anatomical material (omentum, muscle patch), non-absorbable.
- DICOM (Digital Imaging and COmmunications in Medicine) images of the previous treatment plan availability
- Written informed consent
- Patient's ability to understand the characteristics and consequences of the clinical trial
- Hip prosthesis, metal prostheses or any other condition that prevents adequate imaging to identify the target volume and calculate the dose in the treatment plan
- Intestinal infiltration
- Bladder infiltration
- Vessel infiltration
- Previous therapy with anti-angiogenesis drugs
- Psychic or other disorders that may prevent informed consent
- Previous invasive tumor, with the exception of skin cancer (excluding melanoma) unless disease-free for at least 3 years
- Spacer in absorbable material (i.e. vycril)
- Distance \< 10mm between tumour and close intestinal tract (small intestine), radiologically evaluated
- Impossibility to assess MRI
The study team makes the final eligibility decision.
Where it's taking place
- Pavia, Pv, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Pavia, Pv, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.