Clinical trial · Interventional
Magnetic Resonance Imaging-Based Radiation Therapy and Cisplatin in Patients With Stage I, Stage II, Stage III, or Stage IV Cervical Cancer
A Pilot Study of MR Imaging Based Intracavitary Brachytherapy for Cervical Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Poor accrual/enrollments
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 3-dimensional conformal radiation therapy | Radiation | — | UNRESOLVED |
| Cisplatin | Drug | Cisplatin | ALIAS |
| external beam radiation therapy | Radiation | — | UNRESOLVED |
| intensity-modulated radiation therapy | Radiation | — | UNRESOLVED |
| intracavitary balloon brachytherapy | Radiation | — | UNRESOLVED |
| radiation therapy treatment planning/simulation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm I
- 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.
- interventionNames
- 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
Primary outcomes (1)
- measure
- Feasibility of Using MRI for Intracavitary Brachytherapy Treatment Planning.
- timeFrame
- Completion of study
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available