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NCT Number: NCT06462378

Proton Therapy for Locally Advanced Cervical Cancer

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.

Recruiting

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Key information

Conditions

Cervical Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Proton Therapy Radiation Injuries Radiotherapy Side Effect Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms Wounds and Injuries

Age range

18 year–99 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Department of Oncology, Capital Region Denmark

Copenhagen, Denmark

Location status: Recruiting

Location contact

Hanne Matthiesen

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

proton therapy

Radiation

External beam proton therapy combined with standard cisplatin and brachytherapy

Primary outcomes

  1. Acute Bone marrow toxicity

    Time frame: Worst recorded baseline to 3 months after RT

    Grade 2+ Bone marrow toxicity

Secondary outcomes

  1. Late bone marrow toxicity

    Time frame: >3 month to 5 years after RT

    Grade 2+ Bone marrow toxicity

  2. Toxicity

    Time frame: baseline to 5 years after RT

    Toxicity evaluated by NCI-CTCAE v. 5.0 (common terminology criteria for adverse events grade 0-5, 5 indicating worse outcome)

  3. Patient Reported outcomes

    Time frame: baseline to 5 years after treatment

    Patient reported outcomes (by EORTC QLQ-C30, grades 1-4 four indicating worse outcome)

  4. Patient Reported outcomes

    Time frame: baseline to 5 years after treatment

    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)

  5. cisplatin

    Time frame: 3 month

    Cummulative dose (mg)

  6. Oncological outcomes

    Time frame: 5-year

    Progression free survival

  7. Dosimetrics outcomes

    Time frame: 3 month

    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

Other outcomes

  1. Local control

    Time frame: 5-year

    Local tumor control

  2. Overall survial

    Time frame: 5-year

    Overall survial

Study contacts

Contact information is provided by the study sponsor or research team.

Camilla Kronborg, MD, PhD

CONTACT

[email protected]

004592432356

Hanne Matthiesen, MD, PhD

CONTACT

[email protected]

004592432356

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Aarhus University Hospital

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2029
Study completion
2034
First posted
Jun 17, 2024
Registry last updated
Jun 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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