Ignite Creation Date:
2025-12-24 @ 1:00 PM
Ignite Modification Date:
2026-02-25 @ 8:18 PM
Study NCT ID:
NCT01016561
Status:
TERMINATED
Last Update Posted:
2021-05-05
First Post:
2009-11-18
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Magnetic Resonance Imaging-Based Radiation Therapy and Cisplatin in Patients With Stage I, Stage II, Stage III, or Stage IV Cervical Cancer
Sponsor:
Abramson Cancer Center at Penn Medicine
Organization:
Study Overview
Official Title:
A Pilot Study of MR Imaging Based Intracavitary Brachytherapy for Cervical Cancer
Status:
TERMINATED
Status Verified Date:
2021-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Poor accrual/enrollments
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Rationale: Computer systems that allow doctors to create a 3 dimensional (3-D) picture of the tumor may help in planning radiation therapy and may result in more tumor cells being killed. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs, such as cisplatin, may make tumor cells more sensitive to radiation therapy.
Detailed Description:
PURPOSE: This clinical trial is studying magnetic resonance imaging-based radiation therapy and cisplatin in treating patients with stage I, stage II, stage III, or stage IV cervical cancer.Detailed DescriptionPRIMARY OBJECTIVES:
I. To evaluate the feasibility of using MRI based treatment planning for intracavitary brachytherapy treatment planning.
SECONDARY OBJECTIVES:
I. To evaluate the incidence of early toxicities, specifically genitourinary and gastrointestinal.
II. To evaluate the incidence of late toxicities, specifically genitourinary and gastrointestinal.
III. To evaluate local, regional, and distant recurrence rates. IV. To evaluate disease-free and overall survival rates. OUTLINE: Patients undergo external beam radiotherapy (3-dimensional conformal OR intensity-modulated) and 4-6 insertions of MRI-guided intracavitary brachytherapy over 8 weeks. Patients also receive cisplatin IV over 30-60 minutes for 5-6 weeks during radiotherapy.
After completion of study treatment, patients are followed at 6 weeks, every 4 months for 2 years, and then every 6 months for 3 years.
I. To evaluate the feasibility of using MRI based treatment planning for intracavitary brachytherapy treatment planning.
SECONDARY OBJECTIVES:
I. To evaluate the incidence of early toxicities, specifically genitourinary and gastrointestinal.
II. To evaluate the incidence of late toxicities, specifically genitourinary and gastrointestinal.
III. To evaluate local, regional, and distant recurrence rates. IV. To evaluate disease-free and overall survival rates. OUTLINE: Patients undergo external beam radiotherapy (3-dimensional conformal OR intensity-modulated) and 4-6 insertions of MRI-guided intracavitary brachytherapy over 8 weeks. Patients also receive cisplatin IV over 30-60 minutes for 5-6 weeks during radiotherapy.
After completion of study treatment, patients are followed at 6 weeks, every 4 months for 2 years, and then every 6 months for 3 years.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: