Proton Therapy for Locally Advanced Cervical Cancer

NCT06462378 | Recruiting Phase 2

• 1 other identifier: H-22065123
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Cancer; Proton Therapy; Radiotherapy Side Effect

Outcome Measures

Primary Outcomes (1)

• Acute Bone marrow toxicity

  Grade 2+ Bone marrow toxicity

  Worst recorded baseline to 3 months after RT

Secondary Outcomes (7)

• Late bone marrow toxicity

  >3 month to 5 years after RT

• Toxicity

  baseline to 5 years after RT

• Patient Reported outcomes

  baseline to 5 years after treatment

• Patient Reported outcomes

  baseline to 5 years after treatment

• cisplatin

  3 month

Other Outcomes (2)

• Local control

  5-year

• Overall survial

  5-year

Study Arms (1)

Proton therapy

EXPERIMENTAL

Proton therapy

Radiation: Proton therapy

Interventions

Proton therapy RADIATION

External beam proton therapy combined with standard cisplatin and brachytherapy

Proton therapy

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Aarhus: lead
• Aarhus University Hospital: collaborator

Study Sites (1)

Department of Oncology, Capital Region Denmark

Copenhagen, Denmark

RECRUITING

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Radiation Injuries

Interventions

Proton Therapy

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Heavy Ion Radiotherapy; Radiotherapy; Therapeutics

Study Officials

• Hanne Matthiesen, MD, PhD

  Department of Oncology, Capital Region Denmark

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hanne Matthiesen, MD, PhD

CONTACT

004592432356; hanne.from.mathiesen@regionh.dk

Camilla Kronborg, MD, PhD

CONTACT

004592432356; camkro@rm.dk

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Proton therapy

Study Record Dates

• First Submitted: May 28, 2024
• First Posted: June 17, 2024
• Study Start: May 20, 2024
• Primary Completion (Estimated): May 20, 2029
• Study Completion (Estimated): May 20, 2034
• Last Updated: June 17, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)