Re-irradiation for pelvic recurrences of gynecological cancers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness of carbon ion radiation therapy (CIRT) in treating patients with lateral pelvic recurrences of gynecological malignancies that have previously undergone radiation. The primary aim is to assess clinical response rates, while secondary aims include analyzing the safety profile of CIRT and its impact on patient survival. Patients eligible for this study must have specific criteria, including prior radiation therapy and the ability to undergo necessary imaging. The study is conducted at the CNAO National Center of Oncological Hadrontherapy in Pavia, Italy.

Why it matters

Who can join: the full rules

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

Where it's running

• Cnao
  Pavia, Pv, Italy Recruiting

Study contacts

• Principal investigator: Amelia Barcellini, MD — CNAO National Center of Oncological Hadrontherapy
• Study coordinator: Amelia Barcellini, MD
• Email: amelia.barcellini@cnao.it
• Phone: 390382075501

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Testing ONM-501 alone and with Cemiplimab for advanced solid tumors and lymphomas

  This study is testing a new treatment called ONM-501, both alone and with another drug called cemiplimab, to see if it can help people with advanced solid tumors and lymphomas who have run out of other treatment options.

  Recruiting at 5 sites Phase 1 OncoNano Medicine, Inc. · Los Angeles, California and 15 other locations · NCT06022029

• High Dose Rate Brachytherapy for Prostate Cancer Recurrence

  This study is testing if a special type of radiation treatment called High Dose Rate Brachytherapy can help men with prostate cancer that has come back after surgery feel better and have fewer side effects compared to regular radiation.

  Recruiting Clinica Universidad de Navarra, Universidad de Navarra · Pamplona, Foral Community of Navarre · NCT06982469

• Re-irradiation for local prostate cancer recurrences

  This study is testing if a special type of radiation therapy can safely help men whose prostate cancer has come back after previous treatment.

  Recruiting Phase 2 Maria Sklodowska-Curie National Research Institute of Oncology · Gliwice · NCT06201078

• Trimipramine with atezolizumab and bevacizumab for recurrent glioblastoma

  Researchers will try whether adding the antidepressant trimipramine to the immunotherapy atezolizumab plus bevacizumab helps people with recurrent glioblastoma.

  Recruiting at 7 sites Phase 2 Centre Hospitalier Universitaire Vaudois · Basel, Basel and 6 other locations · NCT07263438

• New tool to select liver transplant candidates for liver cancer

  This study is testing a new tool to see if it can help doctors choose more patients with liver cancer for liver transplants, even if they don't meet the usual criteria.

  Recruiting Centro Hospitalar de Lisboa Central · Lisbon · NCT04499833

• Impact of surgical margin width on recurrence and survival in liver cancer from colorectal metastasis

  This study is testing whether having wider surgical margins during liver surgery for colorectal cancer spread can help patients live longer and have fewer recurrences of cancer.

  Recruiting Fudan University · Shanghai, Shanghai Municipality · NCT06934018

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.