Magnetic Resonance Imaging-Based Radiation Therapy and Cisplatin in Patients With Stage I, Stage II, Stage III, or Stage IV Cervical Cancer

NCT01016561 | Terminated Results DMC

• 1 other identifier: UPCC 01809
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  Completion of study

Secondary Outcomes (5)

• Frequency of Grade 2 and Higher Gastrointestinal and Genitourinary Early Event Rates as Compared to Historical Series.

  60 days post treatment

• True Pelvis Failure

  Time to local recurrence

• Pelvis Failure

  Time to loco-regional recurrence

• Progression-free Survival

  Time to recurrence

• Overall Survival

  Time to death

Study Arms (1)

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.

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

Interventions

intracavitary balloon brachytherapy RADIATION

Arm I

external beam radiation therapy RADIATION

Also known as: EBRT

Arm I

intensity-modulated radiation therapy RADIATION

Also known as: IMRT

Arm I

radiation therapy treatment planning/simulation RADIATION

Arm I

3-dimensional conformal radiation therapy RADIATION

Also known as: 3D-CRT, conformal radiation therapy

Arm I

Cisplatin DRUG

Arm I

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead

Study Sites (1)

Abramson Cancer Center of the Unviersity of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Radiotherapy, Intensity-Modulated; Radiotherapy, Conformal; Cisplatin

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Results Point of Contact

• Title: Lilie Lin, MD
• Organization: University of Pennsylvania

lin@xrt.upenn.edu

215-662-6515

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2009
• First Posted: November 19, 2009
• Study Start: July 1, 2009
• Primary Completion: July 1, 2012
• Study Completion: December 1, 2016
• Last Updated: May 5, 2021
• Results First Posted: May 5, 2021

Record last verified: 2021-05

Locations

US (1)