PROTECT: On-line Adaptive Proton Therapy for Cervical Cancer

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

External beam radiation therapy (EBRT) with concurrent chemotherapy followed by brachytherapy is a highly effective treatment for locally advanced cervical cancer (LACC). However, treatment-related toxicity is common and reduces the patient's quality of life (QoL) and may affect ability to complete treatment or undergo adjuvant therapies. Intensity modulated proton therapy (IMPT) enables a significant dose reduction in organs at risk (OAR), when compared to that of standard intensity-modulated radiation therapy (IMRT) or volumetric-modulated arc therapy (VMAT). However, clinical studies evaluating whether IMPT consequently reduces side effects for LACC are lacking. The PROTECT trial is a nonrandomized prospective multicenter phase-II-trial comparing clinical outcomes after IMPT or IMRT/VMAT in LACC. Thirty women aged >18 years with a histological diagnosis of LACC will be included in either the IMPT or IMRT/VMAT group. Treatment includes EBRT (45 Gy in 25 fractions of 1.8 Gy), concurrent five weekly cisplatin (40 mg/m2), and 3D image (MRI)-guided adaptive brachytherapy. The primary endpoint is pelvic bones Dmean and mean bowel V15Gy. Secondary endpoints include dosimetric parameters, oncological outcomes, health-related QoL, immune response, safety, and tolerability. This study provides the first data on the potential of IMPT to reduce OAR dose in clinical practice and improve toxicity and QoL for patients with LACC. ;

Study Design

Related Conditions & MeSH terms

Locally Advanced Cervical Carcinoma
Uterine Cervical Neoplasms

Clinical Trial Details

NCT number	NCT05406856
Study type	Interventional
Source	Leiden University Medical Center
Contact	Anouk Corbeau, MSc
Phone	+31 71 529 7893
Email	a.corbeau@lumc.nl
Status	Recruiting
Phase	N/A
Start date	May 2, 2022
Completion date	December 1, 2026

View Details

See also
Status	Clinical Trial	Phase
Not yet recruiting	`NCT03225443` - Observation and Evaluation of Short-term Curative Effect of Local Advanced Cervical Cancer Treated With Particle Radiotherapy Versus Neoadjuvant Chemotherapy	N/A
Recruiting	`NCT01373723` - Economic Evaluation of Three Populational Screening Strategies for Cervical Cancer	N/A
Terminated	`NCT01234480` - Intended Use Study of the BD SurePath Plus™ Pap
Completed	`NCT02808832` - An HPV Vaccine Provider Intervention in Safety Net Clinics	N/A
Terminated	`NCT01194609` - A Pilot Study of Radiation-Immune Cell Combination Therapy in Cervical Cancer	Phase 1/Phase 2
Terminated	`NCT01075412` - FLT PET Imaging for Cervical Cancer	Phase 2
Completed	`NCT01014026` - Self-sampling and Human Papillomavirus (HPV)-Testing for Unscreened Women in Cervical Cancer Prevention	Phase 3
Completed	`NCT02865889` - Cost-Effectiveness and Patients Satisfaction of Conventional vs Robotic-Assisted Laparoscopy in Gynecologic Oncologic Indications	N/A
Completed	`NCT00377845` - Cervix Cytological Screening - Comparison of Tampon Self-Test and the Routine Smear.	Phase 0
Recruiting	`NCT05531981` - Detection of Minimal Residual Disease Based on HPV ctDNA in Cervical Cancer
Recruiting	`NCT05393440` - First-in-human (FIH) Phase I Trial of BS-006 in Cervical Cancer	Phase 1
Recruiting	`NCT05007106` - MK-7684A With or Without Other Anticancer Therapies in Participants With Selected Solid Tumors (MK-7684A-005) (KEYVIBE-005)	Phase 2
Completed	`NCT02866006` - Safety and Tolerability Evaluation Study of BVAC-C in Patients With HPV Type 16 or 18 Positive Cervical Cancer	Phase 1/Phase 2
Completed	`NCT03270995` - Cognitive-Existential Group Therapy to Reduce Fear of Cancer Recurrence: A RCT Study	N/A
Completed	`NCT02320578` - 2D Versus 3D Radical Laparoscopic Hysterectomy for Cervical Cancer: a Prospective Randomized Trial	N/A
Terminated	`NCT02900248` - CureOne Registry: Advanced Malignancy or Myelodysplasia, Tested by Standard Sequencing and Treated by Physician Choice
Not yet recruiting	`NCT05065853` - Urinary and Vaginal HPV Testing in Cervical Cancer Screening
Completed	`NCT01231945` - Low-Cost Molecular Cervical Cancer Screening Study	N/A
Completed	`NCT01717391` - [F-18] Fluorothymidine PET/CT Imaging for Pelvic Cancers	Phase 2
Active, not recruiting	`NCT04947605` - Epidemiological Landscape of Cervical Cancer in Latin America

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

PROTECT: On-line Adaptive Proton Therapy for Cervical Cancer — PROTECT

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms