PROTECT: Prospective Phase-II-Trial Evaluating Adaptive Proton Therapy for Cervical Cancer to Reduce the Impact on Morbidity and the Immune System.
Anouk Corbeau, Remi A Nout, Jan Willem M Mens...
https://pubmed.ncbi.nlm.nih.gov/34680328Actively Recruiting
Phase Not Applicable
Age: 18Years +
FEMALE
ID05406856
PROTECT: On-line Adaptive Proton Therapy for Cervical Cancer to Reduce the Impact on Morbidity and the Immune System
Led by Leiden University Medical Center · Updated on 2023-10-11
30
Participants Needed
2
Research Sites
74 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
Researchers are evaluating the differences between intensity modulated proton therapy (IMPT) and standard radiation therapies (IMRT or VMAT) in women with locally advanced cervical cancer undergoing chemoradiation. This phase-II, prospective, multicenter trial aims to compare the effects on radiation dose to organs and treatment-related side effects, including impacts on the immune system and quality of life. Thirty women aged 18 and older with a confirmed diagnosis of locally advanced cervical cancer will participate in this study. Participants will receive external beam radiation therapy (EBRT) totaling 45 Gy delivered in 25 daily fractions over 5 weeks, combined with weekly cisplatin chemotherapy for five weeks. After EBRT, all patients undergo MRI-guided adaptive brachytherapy with a high-dose rate system delivering 21 to 28 Gy in fractions of 7 Gy. Women are assigned to either the IMPT group or the IMRT/VMAT group, both receiving chemotherapy and brachytherapy as standard care. The study monitors the dose to pelvic bones and bowel as primary measures. During the study, participants will have multiple assessments including imaging, blood tests, and questionnaires to monitor radiation doses to various organs, immune system effects, treatment safety, tolerability, and quality of life at baseline, during treatment, and up to 12 months after treatment ends. Researchers will also evaluate cancer control by checking survival and recurrence at 3 and 12 months. Follow-up visits include evaluations of immune response and bone marrow changes. The total participation includes treatment and up to one year of follow-up.
CONDITIONS
Brief Title
PROTECT: On-line Adaptive Proton Therapy for Cervical Cancer
Who Can Participate
Age: 18Years +
FEMALE
Eligibility Criteria
You may qualify if you...
- Histologically confirmed cervical cancer (squamous, adenocarcinoma, or adenosquamous carcinoma) with indication for curative chemoradiation including cisplatin and 3D image-guided adaptive brachytherapy
- Inclusion of common iliac or para-aortic lymph nodes in the radiotherapy target volume as specified
- No distant metastasis beyond para-aortic lymph nodes by CT or PET-CT
- Age 18 years or older
- WHO performance status 0-1
- Adequate organ function: creatinine clearance >50 cc/min; white blood cells 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 Ethics Committee requirements
You will not qualify if you...
- Small cell cancer, melanoma, or other rare cervical histologies
- History of another active primary malignancy except certain treated cancers without disease for 5 years
- Severe diseases such as recent myocardial infarction, cardiac failure, or significant arrhythmias
- Previous pelvic or abdominal radiotherapy
- History of active primary immunodeficiency
- Active or prior autoimmune or inflammatory disorders including inflammatory bowel disease
- Use of immunosuppressive drugs at baseline
- Contraindications to weekly cisplatin or carboplatin chemotherapy
- Contraindications for MRI scans
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Approximately 8 to 9 weeks total: 5 weeks of EBRT and chemotherapy, then brachytherapy
Participants receive external beam radiation therapy (EBRT) combined with weekly chemotherapy, followed by MRI-guided adaptive brachytherapy.
Daily visits for 5 weeks for EBRT and weekly chemotherapy visits; brachytherapy involves several sessions as per imaging schedule
Follow-up
Duration - Up to 12 months after end of treatment
Participants are monitored for treatment outcomes, quality of life, safety, and immune system effects.
Visits at Month 1, Month 2, Month 3, Month 6, Month 9, and Month 12 after treatment
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
S
Stephanie M. de Boer, MD, PhD
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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