Proton Therapy for Locally Advanced Cervical Cancer

Cervical Cancer Clinical Trial

Official title:

Proton Therapy in Locally Advanced Cervical Cancer in Combination With Concomitant Chemotherapy and Brachytherapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06462378
• Other study ID #: H-22065123
• Status: Recruiting
• Phase: Phase 2
• Start date: May 20, 2024
• Est. completion date: May 20, 2034

Study information

• Verified date: May 2024
• Source: University of Aarhus
• Contact: Hanne Matthiesen, MD, PhD
• Phone: 004592432356
• Email: hanne.from.mathiesen[@]regionh.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 55
• Est. completion date: May 20, 2034
• Est. primary completion date: May 20, 2029
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Cervical Cancer
• Proton Therapy
• Radiotherapy Side Effect
• Uterine Cervical Neoplasms

Intervention

Radiation:
• Proton therapy
External beam proton therapy combined with standard cisplatin and brachytherapy

Locations

Country	Name	City	State
Denmark	Department of Oncology, Capital Region Denmark	Copenhagen

Sponsors (2)

Lead Sponsor	Collaborator
University of Aarhus	Aarhus University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Local control	Local tumor control	5-year
Other	Overall survial	Overall survial	5-year
Primary	Acute Bone marrow toxicity	Grade 2+ Bone marrow toxicity	Worst recorded baseline to 3 months after RT
Secondary	Late bone marrow toxicity	Grade 2+ Bone marrow toxicity	>3 month to 5 years after RT
Secondary	Toxicity	Toxicity evaluated by NCI-CTCAE v. 5.0 (common terminology criteria for adverse events grade 0-5, 5 indicating worse outcome)	baseline to 5 years after RT
Secondary	Patient Reported outcomes	Patient reported outcomes (by EORTC QLQ-C30, grades 1-4 four indicating worse outcome)	baseline to 5 years after treatment
Secondary	Patient Reported outcomes	Patient reported outcomes (by European Organisation for Research and Treatment of Cancer (EORTC) (Quality of life Questionnaire) QLQ-CX24 grades 1-4 four indicating worse outcome)	baseline to 5 years after treatment
Secondary	cisplatin	Cummulative dose (mg)	3 month
Secondary	Oncological outcomes	Progression free survival	5-year
Secondary	Dosimetrics outcomes	External Beam Radiotherapy dose volume to organs at risk (NCI-CTCAE) and comparison to (Image Guided intensity modulated external beam radiochemotherapy and MRI based adaptive brachy therapy in loaclly advanced cervical cancer) EMBRACE II cohort	3 month