Cervical CancerPhase 2NCT06462378
Proton Therapy for Locally Advanced Cervical Cancer
A Phase 2 study testing Proton therapy in people with Cervical Cancer and Proton Therapy, run by University of Aarhus at 1 site in Denmark.
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). Read more about this study
- Who is it for?
- Ages 18 to 99 years, women only
- Conditions the study is for
- Cervical Cancer, Proton Therapy, Radiotherapy Side Effect
- What is being tested?
- Proton therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteDenmark
- Study dates
- 20 May 2024to 20 May 2034
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- Patient written, informed consent
- Age≥18 years
- Patients must be able to understand a Danish or Swedish
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Department of Oncology, Capital Region Denmark
Copenhagen
Hanne Matthiesen
About this study
Official title: Proton Therapy in Locally Advanced Cervical Cancer in Combination With Concomitant Chemotherapy and Brachytherapy
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.
- Conditions
- Cervical Cancer, Proton Therapy, Radiotherapy Side Effect
- Being tested
- Proton therapy
- Medical subject headings
- Uterine Cervical Neoplasms, Radiation Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proton therapyRadiation
External beam proton therapy combined with standard cisplatin and brachytherapy
| Study group | Role | What they receive |
|---|---|---|
| Proton therapy | Experimental | Proton therapy Receives: Radiation: Proton therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute Bone marrow toxicity
Grade 2+ Bone marrow toxicity
Measured: Worst recorded baseline to 3 months after RT
Secondary outcomes (7)
Late bone marrow toxicity
Grade 2+ Bone marrow toxicity
Measured: >3 month to 5 years after RT
Toxicity
Toxicity evaluated by NCI-CTCAE v. 5.0 (common terminology criteria for adverse events grade 0-5, 5 indicating worse outcome)
Measured: baseline to 5 years after RT
Patient Reported outcomes
Patient reported outcomes (by EORTC QLQ-C30, grades 1-4 four indicating worse outcome)
Measured: baseline to 5 years after treatment
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)
Measured: baseline to 5 years after treatment
cisplatin
Cummulative dose (mg)
Measured: 3 month
Oncological outcomes
Progression free survival
Measured: 5-year
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
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2024
- Study start20 May 2024
- Primary completion20 May 2029 (estimated)
- Study completion20 May 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Proton therapy
- Masking
- None (open label)
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital
- Responsible party
- Sponsor
- Investigators
- Hanne Matthiesen, MD, PhD, Principal investigator, Department of Oncology, Capital Region Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06462378
- Sponsor's protocol ID
- H-22065123
- Status last verified
- May 2024
- First submitted
- 28 May 2024
- Last updated
- 17 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proton Therapy in Locally Advanced Cervical Cancer in Combination With Concomitant Chemotherapy and Brachytherapy
- ClinicalTrials.gov ID
- NCT06462378
- Acronym / sponsor ID
- H-22065123
- Conditions
- Cervical Cancer, Proton Therapy, Radiotherapy Side Effect
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aarhus University Hospital
- Study start
- 20 May 2024 (actual)
- Primary completion
- 20 May 2029 (estimated)
- Study completion
- 20 May 2034 (estimated)
- First posted
- 17 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Proton therapy
| Arm | Type | Receives |
|---|---|---|
| Proton therapy | Experimental | Radiation: Proton therapyProton therapy |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Proton therapyExternal beam proton therapy combined with standard cisplatin and brachytherapy | Radiation | Proton therapy |
Primary outcome
Acute Bone marrow toxicity
Time frame: Worst recorded baseline to 3 months after RT
Grade 2+ Bone marrow toxicity
7 secondary outcomes
Late bone marrow toxicity
Time frame: >3 month to 5 years after RT
Toxicity
Time frame: baseline to 5 years after RT
Patient Reported outcomes
Time frame: baseline to 5 years after treatment
Patient Reported outcomes
Time frame: baseline to 5 years after treatment
cisplatin
Time frame: 3 month
Oncological outcomes
Time frame: 5-year
Dosimetrics outcomes
Time frame: 3 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hanne Matthiesen, MD, PhD principal investigator
Department of Oncology, Capital Region Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Proton therapy in people with Cervical Cancer and Proton Therapy, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hanne Matthiesen, MD, PhD (004592432356, hanne.from.mathiesen@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute Bone marrow toxicity (time frame: Worst recorded baseline to 3 months after RT). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2024.