PROTECT: On-line Adaptive Proton Therapy for Cervical Cancer
PROTECT
1 other identifier
interventional
30
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2022
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 2, 2022
CompletedFirst Submitted
Initial submission to the registry
May 11, 2022
CompletedFirst Posted
Study publicly available on registry
June 7, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
ExpectedOctober 11, 2023
October 1, 2023
3.2 years
May 11, 2022
October 10, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Dmean to the pelvic bones
Mean dose to the pelvic bones (Gy).
During treatment
Mean V15Gy to the bowel
Mean volume of the bowel (cc) receiving 15Gy.
During treatment
Secondary Outcomes (18)
Key dosimetric parameters of the bladder
During treatment
Key dosimetric parameters of the rectum
During treatment
Key dosimetric parameters of the sigmoid
During treatment
Key dosimetric parameters of the bowel
During treatment
Key dosimetric parameters of the body
During treatment
- +13 more secondary outcomes
Study Arms (2)
IMRT/VMAT group
ACTIVE COMPARATORThis group receives standard of care curative treatment with primary external beam radiation therapy (IMRT/VMAT), combined with chemotherapy, followed by 3D image (MRI)-guided adaptive brachytherapy.
IMPT group
EXPERIMENTALThis group receives curative treatment with primary external beam radiation therapy (IMPT), combined with chemotherapy, followed by 3D image (MRI)-guided adaptive brachytherapy.
Interventions
EBRT is given to a total dose of 45 Gy in 25 daily fractions of 1.8 Gy in 5 weeks. Involved nodes are boosted using a simultaneous integrated boost (SIB) to reach a total EBRT plus brachytherapy dose of 60 Gy EQD2 to provide high nodal control.
EBRT is given to a total dose of 45 Gy in 25 daily fractions of 1.8 Gy in 5 weeks. Involved nodes are boosted using a simultaneous integrated boost (SIB) to reach a total EBRT plus brachytherapy dose of 60 Gy EQD2 to provide high nodal control.
The standard chemotherapy regimen is weekly cisplatin (40 mg/m2) for 5 weeks.
Brachytherapy is performed using a high-dose rate (HDR) after loading system to deliver a boost to any residual tumor and the cervix. Brachytherapy dose is (21-) 28 Gy in fractions of 7 Gy specified at 100% isodose around the high-risk CTV, according to the EMBRACE-II prescription protocol. The aim is to reach an equivalent dose in 2 Gy fractions including EBRT (EQD2\_D90) of the high-risk CTV between 90-95 Gy, using MRI-guided adaptive brachytherapy.
Eligibility Criteria
You may qualify if:
- Histologically confirmed diagnosis of cervical cancer (squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma, HPV positive or negative) with an indication for curative treatment with primary chemoradiation with concurrent cisplatin followed by 3D image-guided adaptive brachytherapy.
- Indication to include the common iliac region (minimum 5, maximum 8) or the common iliac and para-aortic regions (minimum 7, maximum 10) into the elective clinical target volume of the external beam radiotherapy.
- No distant metastasis beyond the para-aortic lymph node chain as determined by diagnostic imaging (CT or PET-CT scan)
- Age ≥ 18 years
- WHO 0-1
- Adequate systemic organ function:
- Creatinine clearance (\> 50 cc/min)
- Adequate bone marrow function : white blood cells (WBCs) ≥3.0 x 109/l, neutrophils ≥1.5 x 109/l, platelets ≥100 x 109/l
- Patients must be accessible for treatment and follow-up
- Written informed consent according to the local Ethics Committee requirements
You may not qualify if:
- Small cell cancer, melanoma and other rare histological types of the cervix.
- History of another primary malignancy that could conceivably be active evaluated by the study physician. Examples of exception include, but are not limited to:
- Malignancy treated with curative intent and with no known active disease ≥5 years.
- Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.
- Other severe diseases such as recent myocardial infarction, clinical signs of cardiac failure or clinically significant arrhythmias
- Previous pelvic or abdominal radiotherapy
- History of active primary immunodeficiency
- Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease \[e.g. colitis or Crohn's disease\])
- The use of immunosuppressive drugs at baseline
- Contraindications for weekly Cisplatin (or Carboplatin)
- Contraindications for the use of MRI
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Leiden University Medical Centerlead
- Erasmus Medical Centercollaborator
- HollandPTCcollaborator
Study Sites (2)
Leiden University Medical Center
Leiden, 2333 ZA, Netherlands
Erasmus Medical Center
Rotterdam, 3015 GD, Netherlands
Related Publications (1)
Corbeau A, Nout RA, Mens JWM, Horeweg N, Godart J, Kerkhof EM, Kuipers SC, van Poelgeest MIE, Kroep JR, Boere IA, van Doorn HC, Hoogeman MS, van der Heide UA, Putter H, Welters MJP, van der Burg SH, Creutzberg CL, de Boer SM. PROTECT: Prospective Phase-II-Trial Evaluating Adaptive Proton Therapy for Cervical Cancer to Reduce the Impact on Morbidity and the Immune System. Cancers (Basel). 2021 Oct 15;13(20):5179. doi: 10.3390/cancers13205179.
PMID: 34680328BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stephanie M. de Boer, MD, PhD
Leiden University Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- prof., dr.
Study Record Dates
First Submitted
May 11, 2022
First Posted
June 7, 2022
Study Start
May 2, 2022
Primary Completion
July 1, 2025
Study Completion (Estimated)
December 1, 2026
Last Updated
October 11, 2023
Record last verified: 2023-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, CSR
- Time Frame
- After final publication
- Access Criteria
- Approval by the trial management group is necessary
After completion of the trial and publication of the final results, data will be available upon request with a scientific proposal. Approval by the trial management group is necessary.