Neoplasms

Digestive System Diseases

Gland and Hormone Related Diseases

All Conditions

Rare Diseases

Pancreatic Neoplasms

Adenocarcinoma

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Antineoplastic Agents

All Drugs and Chemicals

Micronutrients

Hematinics

Gastrointestinal Agents

Vitamins

Irinotecan

Leucovorin

Fluorouracil

Levoleucovorin

Oxaliplatin

Folic Acid

Pancrelipase

Pancreatin

Antimetabolites

Immunosuppressive Agents

Immunologic Factors

Topoisomerase I Inhibitors

Enzyme Inhibitors

Folinic Acid

Folate

Vitamin B9

Preoperative chemotherapy, carbon ion therapy, surgery

Preoperative chemotherapy

Preoperative radiotherapy

Francesca Valvo, MD

Direzione medica

Cristina Bono, MSc

Relapses free survival will be evaluated as efficacy of carbon ions radiation therapy released before surgery.

Enrolled subjects will undergo to 3 cycles of Folfirinox before re-evaluation of the lesion. Then, 4D planning and imaging with respiratory gating end rescanning technique will be adopted to calculate the optimal treatment plan to carbon ions radiation therapy: 38.4 Gy\[RBE\] is the prescribed dose to CTV. 4.8 Gy\[RBE\]/fraction will be delivered 4 times a week in two weeks. 4/6 weeks after hadrontherapy, after a CT scan with contrast, patient will undergo to a surgery. After 4/6 weeks, Gemcitabine will be administered for 6 cycles.

Secondary endpoints of the trial are overall survival, resectability rate (operable vs borderline operable), acute toxicity within 3 months, 3-6 months, over 6 months.

The trial enrolls subjects that will receive in order: chemotherapy, carbon ion therapy, followed by surgical resection after 4/6 weeks then adjuvant chemotherapy.

Carbon Ions Radiation Therapy for Resectable or Borderline Resectable Pancreas Adenocarcinoma

Phase II Clinical Study on Resectable or Borderline Resectable Pancreas Adenocarcinoma Preoperative Treatment With Chemotherapy and Carbon Ions Radiation Therapy (Hadrontherapy)

The local progression free survival is measured

the overall survival of enrolled patients is considered

how many surgeries completed according to the procedures and with histopathological margins free from the disease/enrolled patients

Incidence of acute, medium term and late toxicity according to CTCAE v 4.0 grading toxicity

Foundation IRCCS San Matteo Hospital

CNAO National Center of Oncological Hadrontherapy

Principal investigator

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Symptoms and General Pathology

Ovarian Neoplasms

Recurrence

Vulvar Neoplasms

Disease Attributes

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Gonadal Disorders

Ovarian Cancer

Vulvar Cancer

All enrolled subjects will undergo carbon ion radiation therapy. Patients affected by pelvic recurrence of gynecological neoplasia, already undergone to radiotherapy on pelvis, will be enrolled in the study.

CIRT: Planning Target Volume (PTV) will be delivered a total dose of 48-52.8 GyRBE in 12 fractions, 4 fractions per week. Treatment duration 3 weeks.

Treatment lasting more than 5 weeks or cases of treatment with less than 6 fractions in 14 consecutive days will not be accepted.

carbon ion radiation therapy

Amelia Barcellini, MD

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).

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

Enrolled subjects will undergo to carbon ion radiation therapy. It is a monocentric, prospective II study.

The research applies to gynecological tumors.

Clinical Study on the Re-irradiation of Lateral Pelvic Recurrences of Gynecological Malignancies

Phase II Clinical Study on the Re-irradiation of Lateral Pelvic Recurrences of Gynecological Malignancies

absence of progression disease, in patients with lateral pelvic recurrences of gynecological malignancies

Reduction of the tumor volume \> 65% of the initial volume

Volume increase \> 73% of the initial volume.

Tto define acute, intermediate and late toxicities according to Common Terminology Criteria for Adverse Events (CTCAE version 5.0)

Progression free survival (PFS) with qualitative evaluation as a narrative of progression

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Carbon Ions Radiation Therapy for Resectable or Borderline Resectable Pancreas Adenocarcinoma	NCT03822936	Cancer of Pancr... Pancreas Adenoc... Resectable Panc...	Preoperative ch... Preoperative ra...	18 Years - 75 Years	CNAO National Center of Oncological Hadrontherapy
Clinical Study on the Re-irradiation of Lateral Pelvic Recurrences of Gynecological Malignancies	NCT05457595	Tumor Recurrenc... Malignant Epith... Malignant Epith... Malignant Epith...	carbon ion radi...	18 Years -	CNAO National Center of Oncological Hadrontherapy
Carbon Ions Radiation Therapy for Resectable or Borderline Resectable Pancreas Adenocarcinoma	NCT03822936	Cancer of Pancr... Pancreas Adenoc... Resectable Panc...	Preoperative ch... Preoperative ra...	18 Years - 75 Years	CNAO National Center of Oncological Hadrontherapy
Clinical Study on the Re-irradiation of Lateral Pelvic Recurrences of Gynecological Malignancies	NCT05457595	Tumor Recurrenc... Malignant Epith... Malignant Epith... Malignant Epith...	carbon ion radi...	18 Years -	CNAO National Center of Oncological Hadrontherapy

Spots Global Cancer Trial Database for carbon ion radiation therapy