Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05758688
Other study ID # UPCC 27822
Secondary ID 852760
Status Recruiting
Phase N/A
First received
Last updated
Start date November 6, 2023
Est. completion date March 2026

Study information

Verified date December 2023
Source Abramson Cancer Center at Penn Medicine
Contact Neil K Taunk, MD, MSCTS
Phone 267-593-9059
Email taunk@pennmedicine.upenn.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a single institution, multi-center, Phase II, single-arm study, using Whole Pelvis (WP) Pencil Beam Scanning Proton Radiation (PBS PRT) in the post-surgical, adjuvant setting for definitive treatment of gynecologic cancers. The purpose of this study is to estimate rate of acute clinician-reported gastrointestinal (GI) toxicity using WP PBS PRT in the definitive treatment of gynecologic cancers in the post-surgical, adjuvant setting.


Description:

Study Population: This is a single institution, multi-site study, and thus will include patients from geographic locations with Penn proton centers in the Philadelphia, Lancaster and South New Jersey area. Description of Sites/Facilities: The study will be conducted at the University of Pennsylvania Department of Radiation Oncology and associated Clinical facilities. Enrolling Sites: Enrolling sites are within the Penn institution and have proton capabilities. They include the following facilities: 1. Penn Medicine Abramson Center in Philadelphia, PA 2. Penn Medicine Lancaster General Health in Lancaster, PA 3. Penn Medicine Virtua Voorhees in South New Jersey Description of Study Intervention: Patients will be treated with PBS PRT with doses of 45 or 50.4Gy relative biological effectiveness (RBE) in 1.8Gy daily fractions. Study Duration: The duration of the study will be 6 months after the last patient was treated. The recruitment period is planned over 24 months. Thus, estimated time from when study opens to completion of data analysis is 36 months. Participant Duration: 6 months from end of treatment, which including treatment time is approximately 7.5 months


Recruitment information / eligibility

Status Recruiting
Enrollment 25
Est. completion date March 2026
Est. primary completion date September 2025
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - Histologically confirmed cervical or endometrial cancer - Indication for adjuvant whole pelvic radiation therapy, with or without systemic therapy - Age of 18 years or older - Written informed consent - ECOG of 0-2 Exclusion Criteria: - Prior course of pelvic radiation - Metastatic disease outside of the pelvis - Active inflammatory bowel disease - Incapacity to provide informed consent

Study Design


Related Conditions & MeSH terms


Intervention

Radiation:
Whole Pelvis (WP) Pencil Beam Scanning Proton Radiation (PBS PRT)
The study intervention is Whole Pelvis (WP) Pencil Beam Scanning Proton Radiation (PBS PRT) as part of the definitive treatment of gynecologic cancers in the post-hysterectomy, adjuvant setting. Patients will be treated with doses of 45 or 50.4 Gy in 1.8 Gy daily fractions. The volume treated will include the whole pelvis according to Radiation Therapy Oncology Group post-hysterectomy pelvis guidelines.

Locations

Country Name City State
United States Penn Medicine Philadelphia Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
Abramson Cancer Center at Penn Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Acute clinician-reported gastrointestinal (GI) toxicity. Determine the rate of acute clinician-reported gastrointestinal (GI), with the Common Terminology Criteria for Adverse Events (CTCAE v5.0) criteria. This will be assessed and documented up to 6 months after end of treatment at follow up visits.
Secondary Acute clinician-reported genitourinary (GU) toxicity. Determine the rate of the acute patient-reported gastrointestinal (GI) and genitourinary (GU), with the Common Terminology Criteria for Adverse Events (CTCAE v5.0) criteria. These surveys will be administered up to 6 months after end of treatment at follow up visits.
Secondary Acute patient-reported gastrointestinal (GI) and genitourinary (GU) toxicity and quality of life. Determine the rate of acute patient-reported gastrointestinal (GI) and genitourinary (GU) toxicity and quality of life using the EPIC urinary and bowel score (expanded prostate cancer index composite) and FACT-Cx. These surveys will be administered up to 6 months after end of treatment at follow up visits.
Secondary Loco-regional recurrence free survival, disease free survival, and overall survival. Determine loco-regional recurrence free survival, disease free survival, and overall survival. The survival data will be followed until up to 2 years.
See also
  Status Clinical Trial Phase
Recruiting NCT06223308 - A Study Evaluating the Safety and Efficacy of HB0028 in Subjects With Advanced Solid Tumors Phase 1/Phase 2
Terminated NCT03367871 - Combination Pembrolizumab, Chemotherapy and Bevacizumab in Patients With Cervical Cancer Phase 2
Active, not recruiting NCT04537156 - Efficacy, Immunogenicity and Safty Study of Recombinant Human Papillomavirus Vaccine(6,11,16,18,31,33,45,52,58 Type)(E.Coli) Phase 3
Recruiting NCT03668639 - Safety and Antiemetic Efficacy of Akynzeo Plus Dexamethasone During Radiotherapy and Concomitant Weekly Cisplatin Phase 2/Phase 3
Active, not recruiting NCT04242199 - Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099280 in Participants With Advanced Solid Tumors Phase 1
Withdrawn NCT04806945 - A Phase III Study to Evaluate Efficacy and Safety of First-Line Treatment With HLX10 + Chemotherapy in Patients With Advanced Cervical Cancer Phase 3
Active, not recruiting NCT04185389 - Long-Term Follow-Up of HPV FOCAL Participants
Withdrawn NCT03007771 - Magnetic Resonance-guided High-Intensity Focused Ultrasound (MR-HIFU) Used for Mild Hyperthermia Phase 1
Completed NCT03384511 - The Use of 18F-ALF-NOTA-PRGD2 PET/CT Scan to Predict the Efficacy and Adverse Events of Apatinib in Malignancies. Phase 4
Recruiting NCT05107674 - A Study of NX-1607 in Adults With Advanced Malignancies Phase 1
Completed NCT05120167 - Strategies for Endocervical Canal Investigation in Women With Abnormal Screening Cytology and Negative Colposcopy N/A
Recruiting NCT05483491 - KK-LC-1 TCR-T Cell Therapy for Gastric, Breast, Cervical, and Lung Cancer Phase 1
Recruiting NCT05736588 - Elimisha HPV (Human Papillomavirus) N/A
Completed NCT05862844 - Promise Women Project N/A
Recruiting NCT04934982 - Laparoscopic or Abdominal Radical Hysterectomy for Cervical Cancer(Stage IA1 With LVSI, IA2) N/A
Recruiting NCT03876860 - An Enhanced Vaginal Dilator to Reduce Radiation-Induced Vaginal Stenosis N/A
Completed NCT03652077 - A Safety and Tolerability Study of INCAGN02390 in Select Advanced Malignancies Phase 1
Completed NCT00543543 - Broad Spectrum HPV (Human Papillomavirus) Vaccine Study in 16-to 26-Year-Old Women (V503-001) Phase 3
Terminated NCT04864782 - QL1604 Plus Chemotherapy in Subjects With Stage IVB, Recurrent, or Metastatic Cervical Cancer Phase 2/Phase 3
Recruiting NCT04226313 - Self-sampling for Non-attenders to Cervical Cancer Screening N/A