NCT06462378RecruitingPhase 2
Proton Therapy for Locally Advanced Cervical Cancer
Proton Therapy in Locally Advanced Cervical Cancer in Combination With Concomitant Chemotherapy and Brachytherapy
Source: ClinicalTrials.gov · Last updated 17 Jun 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 55 (estimated)
- First submitted
- 28 May 2024
- Start date
- 20 May 2024
- Primary completion date
- 20 May 2029
- Lead sponsor
- University of Aarhus
- Diseases
- Cervical cancer
- NCT number
- NCT06462378
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 55
- From 20 May 2024 to the primary completion date, 20 May 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous pelvic or abdominal radiotherapy
- Combination of preoperative radiotherapy with surgery
- Patients receiving neoadjuvant chemotherapy
Other illness
- 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)
- Active infection or severe medical condition endangering treatment delivery
- Human Immune Deficiency Virus (HIV)
Other
- Contra indications to MRI
- Contra indications to IGABT
- Contra indications to protontherapy
- Small cell histology (neuroendocrine tumors)
- Pregnant, lactating or childbearing potential without adequate contraception
- Patients with no possibility of follow up
Who the study is looking for
- 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
Age in the registry: 18 years to 99 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Oncology, Capital Region Denmark Coordinator of this site? Confirm its status | Copenhagen | Denmark | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.