Clinical trial NCT05457595: Clinical Study on the Re-irradiation of Lateral Pelvic Recurrences of Gynecological Malignancies
Official title: Phase II Clinical Study on the Re-irradiation of Lateral Pelvic Recurrences of Gynecological Malignancies
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Tumor Recurrence
Malignant Epithelial Neoplasm of Vulva
Malignant Epithelial Tumor of Ovary
Malignant Epithelial Neoplasm
Keywords: gynecological cancer
carbon ion radiation therapy
recurrencies
CIRT
Lead sponsor: CNAO National Center of Oncological Hadrontherapy
Sponsor class: OTHER
First posted: 2022-07-14
Enrollment: 55
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Enrolled subjects will undergo to carbon ion radiation therapy. It is a monocentric, prospective II study.
Primary purpose: TREATMENT

Brief summary: 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).

Detailed description: Primary aim: estimate the effect, in terms of clinical response, of carbon ion treatment (CIRT) in patients with lateral pelvic recurrences of gynecological malignancies.

Secondary aims:

1. To describe the safety profile of carbon ion therapy.
2. To estimate the effect, in terms of survival, of carbon ion treatment

Eligibility criteria: Inclusion 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: local control
timeFrame: 1 year after treatment
measure: complete response
timeFrame: 1 year after treatment
measure: partial response
timeFrame: 1 year after treatment
measure: stable disease
timeFrame: 1 year after treatment
measure: progression disease
timeFrame: 1 year after treatment
Secondary outcomes:
measure: overall survival
timeFrame: 1 year after treatment
measure: Toxicity assessment according to CTCAE v. 5
timeFrame: 1 year after treatment
measure: Progression free survival
timeFrame: 1 year after treatment
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: CNAO
state: Pv
Study officials:
affiliation: CNAO National Center of Oncological Hadrontherapy
name: Amelia Barcellini, MD
role: PRINCIPAL_INVESTIGATOR
References: