Clinical Trials Logo

Clinical Trial Summary

The study investigators will conduct a prospective study on patients with non-metastatic vulvar cancer who will receive radiation treatment using Volumetric Arc Therapy (VMAT) modality with curative intent. Our aim is to compare straight-leg versus frog-leg position in terms of RTOG acute skin toxicity. Also, the study investigators will evaluate if positioning has an impact on the total treatment time and deviation on Cone Beam CT (CBCT) that might warrant re-simulation and consequently re-planning.


Clinical Trial Description

Vulvar cancer is a rare tumor with a prevalence of about 3-5% of gynecological malignancies with squamous cell carcinoma being the most common histopathologic subtype. It is more common among elderly and postmenopausal women. Surgery is the cornerstone for the management of patients with early stage vulvar cancer. Radiotherapy is an integral part of the management of vulvar cancer both in the definitive and adjuvant settings. Several studies have shown that intensity modulated radiotherapy IMRT is associated with better locoregional control compared with 3-dimensional conformal radiotherapy 3DCRT. In addition, it is associated with dosimetric advantage and better sparing of the organs at risk. Historically, frog-leg position was the standard to provide better access for electron boost in conventional era. After evolution of inverse planning, electron boost is not further needed. Some centers have adopted straight-leg position. There is paucity of literature regarding vulvar cancer in general and there is lack of data addressing radiation therapy treatment position specifically. The study investigators will conduct a prospective study on patients with non-metastatic vulvar cancer who will receive radiation treatment using Volumetric Arc Therapy (VMAT) modality with curative intent. Our aim is to compare straight-leg versus frog-leg position in terms of RTOG acute skin toxicity. Also, the investigators will evaluate if positioning has an impact on the total treatment time and deviation on Cone Beam CT (CBCT) that might warrant re-simulation and consequently re-planning. If both positions proved to be similar in terms of skin toxicity, then the investigators will adopt supine position in the treatment of all patients with vulvar cancer. It will be more comfortable position, and so more reproducible and this reproducibility will be reflected on better treatment outcomes. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05014191
Study type Observational
Source King Hussein Cancer Center
Contact FAWZI J Abuhijla, MD, MSc
Phone +962796500577
Email fhijle@khcc.jo
Status Recruiting
Phase
Start date July 1, 2020
Completion date December 1, 2024

See also
  Status Clinical Trial Phase
Completed NCT04059809 - Photobiomodulation for Breast Cancer Radiodermatitis Phase 2/Phase 3
Recruiting NCT03876860 - An Enhanced Vaginal Dilator to Reduce Radiation-Induced Vaginal Stenosis N/A
Completed NCT02058550 - Phone or Email Reminder in Increasing Vaginal Dilator Use in Patients With Gynecologic Cancers Undergoing Brachytherapy Phase 1
Completed NCT01399372 - Rituximab, Methotrexate, Vincristine Sulfate, Procarbazine Hydrochloride, and Cytarabine With or Without Radiation Therapy in Treating Patients With Primary Central Nervous System Lymphoma Phase 2
Completed NCT01434290 - Radiation Therapy in Treating Patients With Prostate Cancer Phase 2
Active, not recruiting NCT00087815 - Hyperbaric Oxygen Therapy in Treating Patients With Radiation Necrosis of the Brain N/A
Completed NCT01407770 - Genetic Susceptibility to Radiation-Induced Skin Reactions in Racial/Ethnic Groups of Patients With Breast Cancer
Completed NCT00003313 - Amifostine in Treating Patients With Stage II or Stage III Non-small Cell Lung Cancer Phase 3
Completed NCT03783364 - Pre- or Postoperative Accelerated Radiotherapy N/A
Enrolling by invitation NCT04305613 - Cardiotoxicity in Locally Advanced Lung Cancer Patients Treated With Chemoradiation Therapy
Recruiting NCT06036706 - Neurocognitive Impact of Different Irradiation Modalities for Patients With Grade I-II Skull Base Meningioma: N/A
Withdrawn NCT04593914 - A Novel Skin Barrier Protectant for Acute Radiodermatitis N/A
Recruiting NCT04110223 - Validation Studies of Biomarkers for Precision Radiation Oncology in Locally Advanced Solid Tumors
Active, not recruiting NCT02259218 - Metabolomic and Epigenetic Profiling of Bodyfluids From Lung and Brain Cancer Receiving Radiation Therapy
Recruiting NCT06073509 - Atrial Fibrillation and Other Cardiac Arrhythmias and Diseases After Radiotherapy for Breast Cancer : Watch Your HeaRT
Withdrawn NCT02017925 - Pulmonary Rehabilitation in Improving Lung Function in Patients With Locally Advanced Non-Small Cell Lung Cancer Undergoing Chemoradiation N/A
Completed NCT01170299 - Low-Fiber Diet or High-Fiber Diet in Preventing Bowel Side Effects in Patients Undergoing Radiation Therapy for Gynecological Cancer, Bladder Cancer, Colorectal Cancer, or Anal Cancer N/A
Completed NCT00974168 - Spinal Cord Compression Re-Treat Study Phase 2
Completed NCT00008398 - Sargramostim in Decreasing Mucositis in Patients Receiving Radiation Therapy for Head and Neck Cancer Phase 3
Enrolling by invitation NCT04047823 - Temperature and Injury in Radiotherapy Radiation Skin Injury