Cervical CancerNCT01016561
Magnetic Resonance Imaging-Based Radiation Therapy and Cisplatin in Patients With Stage I, Stage II, Stage III, or Stage IV Cervical Cancer
A study testing intracavitary balloon brachytherapy, external beam radiation therapy and intensity-modulated radiation therapy in people with Cervical Cancer, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- intracavitary balloon brachytherapy, external beam radiation therapy and intensity-modulated radiation therapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2009to Dec 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Abramson Cancer Center of the Unviersity of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: A Pilot Study of MR Imaging Based Intracavitary Brachytherapy for Cervical Cancer
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.
Read the 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:
- To evaluate the feasibility of using MRI based treatment planning for intracavitary brachytherapy treatment planning.
SECONDARY OBJECTIVES:
- 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.
- Conditions
- Cervical Cancer
- Being tested
- intracavitary balloon brachytherapy, external beam radiation therapy, intensity-modulated radiation therapy, radiation therapy treatment planning/simulation, 3-dimensional conformal radiation therapy
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intracavitary balloon brachytherapyRadiation
external beam radiation therapyRadiation
Also called EBRT
intensity-modulated radiation therapyRadiation
Also called IMRT
radiation therapy treatment planning/simulationRadiation
3-dimensional conformal radiation therapyRadiation
Also called 3D-CRT, conformal radiation therapy
CisplatinDrug
| Study group | Role | What they receive |
|---|---|---|
| Arm I | Experimental | 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Using MRI for Intracavitary Brachytherapy Treatment Planning.
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.
Measured: Completion of study
Secondary outcomes (5)
Frequency of Grade 2 and Higher Gastrointestinal and Genitourinary Early Event Rates as Compared to Historical Series.
Measured: 60 days post treatment
True Pelvis Failure
Measured: Time to local recurrence
Pelvis Failure
Measured: Time to loco-regional recurrence
Progression-free Survival
Measured: Time to recurrence
Overall Survival
Measured: Time to death
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2009 (estimated)
- Study startJul 2009
- Primary completionJul 2012
- Study completionDec 2016
Why it stopped: Poor accrual/enrollments
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by Abramson Cancer Center at Penn MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01016561
- Sponsor's protocol ID
- UPCC 01809
- Status last verified
- May 2021
- First submitted
- 18 Nov 2009
- Last updated
- 5 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of MR Imaging Based Intracavitary Brachytherapy for Cervical Cancer
- ClinicalTrials.gov ID
- NCT01016561
- Acronym / sponsor ID
- UPCC 01809
- Conditions
- Cervical Cancer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor accrual/enrollments
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Jul 2012 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 19 Nov 2009 (estimated)
- Results
- Posted 5 May 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To evaluate the feasibility of using MRI based treatment planning for intracavitary brachytherapy treatment planning.
SECONDARY OBJECTIVES:
- 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm I | Experimental | 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: CisplatinPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intracavitary balloon brachytherapy | Radiation | Arm I |
| external beam radiation therapyAlso: EBRT | Radiation | Arm I |
| intensity-modulated radiation therapyAlso: IMRT | Radiation | Arm I |
| radiation therapy treatment planning/simulation | Radiation | Arm I |
| 3-dimensional conformal radiation therapyAlso: 3D-CRT, conformal radiation therapy | Radiation | Arm I |
| Cisplatin | Drug | Arm I |
Primary outcome
Feasibility of Using MRI for Intracavitary Brachytherapy Treatment Planning.
Time frame: 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.
5 secondary outcomes
Frequency of Grade 2 and Higher Gastrointestinal and Genitourinary Early Event Rates as Compared to Historical Series.
Time frame: 60 days post treatment
True Pelvis Failure
Time frame: Time to local recurrence
Pelvis Failure
Time frame: Time to loco-regional recurrence
Progression-free Survival
Time frame: Time to recurrence
Overall Survival
Time frame: Time to death
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Cervical Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
Proton Re-irradiation in Patients With Recurrent or Second Primary Head and Neck Cancer , a Multicentre Phase II Single Arm Trial
Head & Neck Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
RecruitingPhase 4
Lidocaine Infiltration and Neuroimmunomodulation in Head and Neck Cancer Surgery
Head and Neck Cancer (H&N)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intracavitary balloon brachytherapy, external beam radiation therapy and intensity-modulated radiation therapy in people with Cervical Cancer, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of Using MRI for Intracavitary Brachytherapy Treatment Planning. (time frame: Completion of study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2021.