Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
NCT05406856

PROTECT: On-line Adaptive Proton Therapy for Cervical Cancer

Led by Leiden University Medical Center · Updated on 2023-10-11

30

Participants Needed

2

Research Sites

239 weeks

Total Duration

On this page

Sponsors

L

Leiden University Medical Center

Lead Sponsor

E

Erasmus Medical Center

Collaborating Sponsor

AI-Summary

What this Trial Is About

This prospective, multicenter, nonrandomized phase-II-trial investigates in clinical practice the differences between intensity modulated proton therapy (IMPT) and standard intensity-modulated radiation therapy (IMRT) or volumetric-modulated arc therapy (VMAT) in the effects on dose-volume parameters and treatment-related morbidity for women with locally advanced cervical cancer undergoing chemoradiation.

CONDITIONS

Official Title

PROTECT: On-line Adaptive Proton Therapy for Cervical Cancer

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Histologically confirmed cervical cancer (squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma, HPV positive or negative) with indication for curative chemoradiation including cisplatin and 3D image-guided adaptive brachytherapy
  • Indication to include common iliac region (5 to 8) or common iliac and para-aortic regions (7 to 10) in the elective clinical target volume of external beam radiotherapy
  • No distant metastasis beyond para-aortic lymph node chain as shown by CT or PET-CT scan
  • Age 18 years or older
  • WHO performance status 0-1
  • Adequate organ function including creatinine clearance > 50 cc/min and sufficient bone marrow function (WBC ≥ 3.0 x 10^9/l, neutrophils ≥ 1.5 x 10^9/l, platelets ≥ 100 x 10^9/l)
  • Accessible for treatment and follow-up
  • Provided written informed consent according to local Ethics Committee requirements
Not Eligible

You will not qualify if you...

  • Small cell cancer, melanoma, or other rare cervical cancer histological types
  • History of other primary malignancy that may be active, except cured malignancies without disease for ≥5 years or treated non-melanoma skin cancer/lentigo maligna without evidence of disease
  • Severe diseases like recent heart attack, heart failure signs, or significant arrhythmias
  • Previous pelvic or abdominal radiotherapy
  • History of active primary immunodeficiency
  • Active or prior autoimmune or inflammatory diseases, including inflammatory bowel disease such as colitis or Crohn's disease
  • Use of immunosuppressive drugs at baseline
  • Contraindications to weekly cisplatin or carboplatin chemotherapy
  • Contraindications to MRI use in the study procedures

AI-Screening

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Trial Site Locations

Total: 2 locations

1

Leiden University Medical Center

Leiden, Netherlands, 2333 ZA

Actively Recruiting

2

Erasmus Medical Center

Rotterdam, Netherlands, 3015 GD

Not Yet Recruiting

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Research Team

A

Anouk Corbeau, MSc

CONTACT

S

Stephanie M. de Boer, MD, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

2

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