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 of the University of Pennsylvania (Other)
• Overall Status: Terminated
• CT.gov ID: NCT01016561
• Collaborator: (none)
• Enrollment: 12
• Location: 1
• Arm: 1
• Duration (Months): 89
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cervical Cancer	Radiation: intracavitary balloon brachytherapy; Radiation: external beam radiation therapy; Radiation: intensity-modulated radiation therapy; Radiation: radiation therapy treatment planning/simulation; Radiation: 3-dimensional conformal radiation therapy; Drug: Cisplatin	N/A

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:

1. To evaluate the feasibility of using MRI based treatment planning for intracavitary brachytherapy treatment planning.

SECONDARY OBJECTIVES:

1. To evaluate the incidence of early toxicities, specifically genitourinary and gastrointestinal.

2. To evaluate the incidence of late toxicities, specifically genitourinary and gastrointestinal.

3. 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 Design

• Study Type: Interventional
• Actual Enrollment: 12 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Pilot Study of MR Imaging Based Intracavitary Brachytherapy for Cervical Cancer
• Study Start Date: Jul 1, 2009
• Actual Primary Completion Date: Jul 1, 2012
• Actual Study Completion Date: Dec 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm I 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.	Radiation: intracavitary balloon brachytherapy; Radiation: external beam radiation therapy; Other Names: EBRT ; Radiation: intensity-modulated radiation therapy; Other Names: IMRT ; Radiation: radiation therapy treatment planning/simulation; Radiation: 3-dimensional conformal radiation therapy; Other Names: 3D-CRT, conformal radiation therapy ; Drug: Cisplatin

Outcome Measures

Primary Outcome Measures

1. Feasibility of Using MRI for Intracavitary Brachytherapy Treatment Planning. [Completion of study]

   Feasibility will be defined if no greater than 10% of patients experience one of the following events: a) patient is unable to tolerate 50% of MRI-based brachytherapy treatments and b) patient experiences any grade 4 acute ("early") non-hematologic toxicity attributed to brachytherapy. Acute toxicity occurs within 60 days of therapy.

Secondary Outcome Measures

1. Frequency of Grade 2 and Higher Gastrointestinal and Genitourinary Early Event Rates as Compared to Historical Series. [60 days post treatment]

2. True Pelvis Failure [Time to local recurrence]

3. Pelvis Failure [Time to loco-regional recurrence]

4. Progression-free Survival [Time to recurrence]

5. Overall Survival [Time to death]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Subjects must have histologically confirmed squamous cell, adenosquamous or adenocarcinoma of the cervix

• Subjects must have non-metastatic FIGO Stage Ia-IVa cervical cancer

• Claustrophobic subjects must agree to be sedated during MRI procedures

• ECOG performance status of 0-2

Exclusion Criteria:

• Subjects with an inability to tolerate MR imaging

• Subjects who have had prior surgery for treatment of disease other than exploratory laparotomy or biopsy

• Study subjects who have contraindication to MRI scanning such as but not limited to subjects with pacemakers, metal fragments in the eye or certain metallic implants

• Women of childbearing potential who have a positive result on screening serum pregnancy test

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Abramson Cancer Center of the Unviersity of Pennsylvania	Philadelphia	Pennsylvania	United States	19104

Sponsors and Collaborators

• Abramson Cancer Center of the University of Pennsylvania

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Abramson Cancer Center of the University of Pennsylvania
• ClinicalTrials.gov Identifier: NCT01016561
• Other Study ID Numbers: UPCC 01809
• First Posted: Nov 19, 2009
• Last Update Posted: May 5, 2021
• Last Verified: May 1, 2021

• Additional relevant MeSH terms: Uterine Cervical Neoplasms; Cisplatin

Study Results

Participant Flow

Arm/Group Title	Arm I
Arm/Group Description	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. intracavitary balloon brachytherapy external beam radiation therapy intensity-modulated radiation therapy radiation therapy treatment planning/simulation 3-dimensional conformal radiation therapy Cisplatin
Period Title: Overall Study
STARTED	0
COMPLETED	0
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Arm I
Arm/Group Description	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. intracavitary balloon brachytherapy external beam radiation therapy intensity-modulated radiation therapy radiation therapy treatment planning/simulation 3-dimensional conformal radiation therapy Cisplatin
Overall Participants	0
Age () []
<=18 years
Between 18 and 65 years
>=65 years
Age (years) []
Sex: Female, Male () []
Female
Male
Ethnicity (NIH/OMB) () []
Hispanic or Latino
Not Hispanic or Latino
Unknown or Not Reported
Race (NIH/OMB) () []
American Indian or Alaska Native
Asian
Native Hawaiian or Other Pacific Islander
Black or African American
White
More than one race
Unknown or Not Reported
Region of Enrollment (participants) []

Outcome Measures

1. Primary Outcome

Title	Feasibility of Using MRI for Intracavitary Brachytherapy Treatment Planning.
Description	Feasibility will be defined if no greater than 10% of patients experience one of the following events: a) patient is unable to tolerate 50% of MRI-based brachytherapy treatments and b) patient experiences any grade 4 acute ("early") non-hematologic toxicity attributed to brachytherapy. Acute toxicity occurs within 60 days of therapy.
Time Frame	Completion of study

Outcome Measure Data

Analysis Population Description

he study was terminated and the PI has left the institution. Despite all possible efforts to contact the PI/study team members, no data are available to be reported

Arm/Group Title	Arm I
Arm/Group Description	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. intracavitary balloon brachytherapy external beam radiation therapy intensity-modulated radiation therapy radiation therapy treatment planning/simulation 3-dimensional conformal radiation therapy Cisplatin
Measure Participants	0

2. Secondary Outcome

Title	Frequency of Grade 2 and Higher Gastrointestinal and Genitourinary Early Event Rates as Compared to Historical Series.
Time Frame	60 days post treatment

Outcome Measure Data

Analysis Population Description

he study was terminated and the PI has left the institution. Despite all possible efforts to contact the PI/study team members, no data are available to be reported

Arm/Group Title	Arm I
Arm/Group Description	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. intracavitary balloon brachytherapy external beam radiation therapy intensity-modulated radiation therapy radiation therapy treatment planning/simulation 3-dimensional conformal radiation therapy Cisplatin
Measure Participants	0

3. Secondary Outcome

Title	True Pelvis Failure
Time Frame	Time to local recurrence

Outcome Measure Data

Analysis Population Description

he study was terminated and the PI has left the institution. Despite all possible efforts to contact the PI/study team members, no data are available to be reported

Arm/Group Title	Arm I
Arm/Group Description	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. intracavitary balloon brachytherapy external beam radiation therapy intensity-modulated radiation therapy radiation therapy treatment planning/simulation 3-dimensional conformal radiation therapy Cisplatin
Measure Participants	0

4. Secondary Outcome

Title	Pelvis Failure
Time Frame	Time to loco-regional recurrence

Outcome Measure Data

Analysis Population Description

he study was terminated and the PI has left the institution. Despite all possible efforts to contact the PI/study team members, no data are available to be reported

Arm/Group Title	Arm I
Arm/Group Description	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. intracavitary balloon brachytherapy external beam radiation therapy intensity-modulated radiation therapy radiation therapy treatment planning/simulation 3-dimensional conformal radiation therapy Cisplatin
Measure Participants	0

5. Secondary Outcome

Title	Progression-free Survival
Time Frame	Time to recurrence

Outcome Measure Data

Analysis Population Description

he study was terminated and the PI has left the institution. Despite all possible efforts to contact the PI/study team members, no data are available to be reported

Arm/Group Title	Arm I
Arm/Group Description	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. intracavitary balloon brachytherapy external beam radiation therapy intensity-modulated radiation therapy radiation therapy treatment planning/simulation 3-dimensional conformal radiation therapy Cisplatin
Measure Participants	0

6. Secondary Outcome

Title	Overall Survival
Time Frame	Time to death

Outcome Measure Data

Analysis Population Description

Not enough patients were accrued to the study for analysis.

Arm/Group Title	Arm I
Arm/Group Description	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. intracavitary balloon brachytherapy external beam radiation therapy intensity-modulated radiation therapy radiation therapy treatment planning/simulation 3-dimensional conformal radiation therapy Cisplatin
Measure Participants	0

Adverse Events

Adverse Event Reporting Description	The study was terminated and the PI has left the institution. Despite all possible efforts to contact the PI/study team members, no data are available to be reported
Arm/Group Title	Arm I
Arm/Group Description	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. intracavitary balloon brachytherapy external beam radiation therapy intensity-modulated radiation therapy radiation therapy treatment planning/simulation 3-dimensional conformal radiation therapy Cisplatin
All Cause Mortality
	Arm I
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)
Serious Adverse Events
	Arm I
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Arm I
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.