Clinical trial NCT06462378: Proton Therapy for Locally Advanced Cervical Cancer
Official title: Proton Therapy in Locally Advanced Cervical Cancer in Combination With Concomitant Chemotherapy and Brachytherapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Cervical Cancer
Proton Therapy
Radiotherapy Side Effect
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
First posted: 2024-06-17
Enrollment: 55
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Proton therapy
Primary purpose: TREATMENT

Brief summary: The purpose of this protocol is to determine toxicity and efficacy of proton therapy in combination with standard concomitant platinum-based chemotherapy and standard image-guided adaptive brachytherapy (IGABT) in patients with locally advanced cervical cancer (LACC). The over-all aim is to maintain a high disease control and at the same time reduce acute morbidity as well as late side effects after treatment.


Eligibility criteria: Inclusion Criteria:

* Inclusion criteria:

  * Cancer of the uterine cervix considered suitable for curative treatment with definitive radio- (chemo) therapy including IGABT
  * Positive biopsy showing squamous-cell carcinoma, adenocarcinoma or adeno-squamous cell carcinoma of the uterine cervix.
  * Staging according to Intenational federation of Gynecology and Obstetrics (FIGO) and TNM guidelines
  * T1-3N1M0 (FIGO stage IIIC1 (with ≥3 pelvic lymph node metastases) and IIIC2)
  * Para-aortic metastatic nodes below L1-L2 are allowed (FIGO stage IVB)
  * Magnetic Resonance Imaging (MRI) and Positron Emission Tomogaraphy-computerized Tomograpy (PET-CT) of the retroperitoneal space and abdomen at diagnosis
  * Patient written, informed consent
  * Age≥18 years
  * Patients must be able to understand a Danish or Swedish

Exclusion Criteria:

* Other primary malignancies except carcinoma in situ of the cervix and basal cell carcinoma of the skin
* Metastatic disease beyond para-aortic region (L1-L2 interspace)
* Previous pelvic or abdominal radiotherapy
* Combination of preoperative radiotherapy with surgery
* Patients receiving neoadjuvant chemotherapy
* Contra indications to MRI
* Contra indications to IGABT
* Contra indications to protontherapy
* Small cell histology (neuroendocrine tumors)
* Active infection or severe medical condition endangering treatment delivery
* Pregnant, lactating or childbearing potential without adequate contraception
* Human Immune Deficiency Virus (HIV)
* Patients with no possibility of follow up

Primary outcomes:
measure: Acute Bone marrow toxicity
timeFrame: Worst recorded baseline to 3 months after RT
Secondary outcomes:
measure: Late bone marrow toxicity
timeFrame: >3 month to 5 years after RT
measure: Toxicity
timeFrame: baseline to 5 years after RT
measure: Patient Reported outcomes
timeFrame: baseline to 5 years after treatment
measure: Patient Reported outcomes
timeFrame: baseline to 5 years after treatment
measure: cisplatin
timeFrame: 3 month
measure: Oncological outcomes
timeFrame: 5-year
measure: Dosimetrics outcomes
timeFrame: 3 month
Other outcomes:
measure: Local control
timeFrame: 5-year
measure: Overall survial
timeFrame: 5-year
Locations:
city: Copenhagen
country: Denmark
facility: Department of Oncology, Capital Region Denmark
Study officials:
affiliation: Department of Oncology, Capital Region Denmark
name: Hanne Matthiesen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: