Proton Therapy for Locally Advanced Cervical Cancer | NCT06462378

Studies
Proton Therapy for Locally Advanced Cervical Cancer

NCT06462378

Sponsor

University of Aarhus

Status

Recruiting

Last Update Posted

Jun 17, 2024Actual

Enrollment

55Estimated

Phase

Phase 2

Conditions

Cervical Cancer
Proton Therapy
Radiotherapy Side Effect

Interventions

Proton therapy

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 20, 2024Actual

Primary Completion Date

May 20, 2029Estimated

Completion Date

May 20, 2034Estimated

First Submitted Date

May 28, 2024

First Submission Date that Met QC Criteria

Jun 11, 2024

First Posted Date

Jun 17, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 11, 2024

Last Update Posted Date

Jun 17, 2024Actual

Name	Class
Aarhus University Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

55Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Proton therapy	Experimental	Proton therapy	Radiation: Proton therapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Proton therapy	Radiation	External beam proton therapy combined with standard cisplatin and brachytherapy	Proton therapy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Acute Bone marrow toxicity	Grade 2+ Bone marrow toxicity	Worst recorded baseline to 3 months after RT

Secondary Outcomes

Measure	Description	Time Frame
Late bone marrow toxicity	Grade 2+ Bone marrow toxicity	>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)

Other Outcomes

Measure	Description	Time Frame
Local control	Local tumor control	5-year
Overall survial	Overall survial	5-year

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

99 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Hanne Matthiesen, MD, PhD	Contact	004592432356		hanne.from.mathiesen@regionh.dk
Camilla Kronborg, MD, PhD	Contact	004592432356		camkro@rm.dk

Overall Officials

Name	Affiliation	Role
Hanne Matthiesen, MD, PhD	Department of Oncology, Capital Region Denmark	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Oncology, Capital Region Denmark	Recruiting	Copenhagen			Denmark

ID	Term
D002583	Uterine Cervical Neoplasms
D011832	Radiation Injuries

ID	Term
D014594	Uterine Neoplasms
D005833	Genital Neoplasms, Female
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site

ID	Term
D063193	Heavy Ion Radiotherapy
D011878	Radiotherapy
D013812	Therapeutics