Radiation Therapy in Treating Patients With Cervical Cancer

Cervical Cancer Clinical Trial

Official title:

A Pilot Study of MR-Guided High Dose Rate Brachytherapy With MR Image Acquisition for Patients With Cervical Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00278304
• Other study ID #: CDR0000454997
• Secondary ID: NCI-05-C-0233
• Status: Completed
• Phase: Phase 2
• First received: January 16, 2006
• Last updated: June 18, 2013
• Start date: September 2005
• Est. completion date: June 2006

Study information

• Verified date: April 2006
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Internal radiation uses radioactive material placed directly into or near a tumor to kill tumor cells. Giving radiation therapy in different ways may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving external-beam radiation together with internal radiation works in treating patients with cervical cancer.

Description:

OBJECTIVES:

Primary

• Determine the feasibility of magnetic resonance-guided, endocavitary, high-dose rate brachytherapy implants in patients with stage IB-IVB cervical cancer.

• Provide more reliable dose-volume estimations based on three-dimensional imaging-based treatment planning in patients treated with this regimen.

Secondary

• Determine the toxic effects and treatment tolerance in patients treated with this regimen.

• Correlate three-dimensional dose-volume histograms of organs at risk with treatment toxicity in patients treated with this regimen.

• Determine the disease status, time and patterns of relapse, and survival of patients treated with this regimen.

OUTLINE: Patients undergo external beam radiotherapy 4-5 days a week for up to 7 weeks. Patients also undergo MRI-guided high-dose brachytherapy comprising one brachytherapy implant a week for 3-6 implants. Brachytherapy may be administered during or after external beam radiotherapy.

After completion of study treatment, patients are followed periodically for 5 years.

PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.

Other known NCT identifiers

• NCT00214396

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

DISEASE CHARACTERISTICS:

• Histologically confirmed carcinoma of the cervix of 1 of the following cellular subtypes:

• Squamous cell

• Adenocarcinoma

• Adenosquamous cell

• Stages IB-IVA disease

• Stage IVB disease allowed provided the impact on the quality of life is tremendous (e.g., "frozen pelvis" or massive pelvic disease and fistula formation, severe pain, or bleeding)

• Measurable and/or evaluable disease on MRI

PATIENT CHARACTERISTICS:

• ECOG performance status 0-2

• No physical or physiological capacity that would preclude study treatment

• No cognitively impaired patients who cannot provide informed consent

• Not pregnant or nursing

• Negative pregnancy test

• No contraindication to MRI, including any of the following:

• Weight > 136 kg

• Allergy to MR contrast agent

• Pacemakers, cerebral aneurysm clips, shrapnel injury, or implantable electronic devices

• No significant unrelated systemic illness

• No serious infections

• No significant cardiac, pulmonary, hepatic, or other organ dysfunction that would preclude study treatment

• Must be medically fit to receive anesthesia

PRIOR CONCURRENT THERAPY:

• No prior definitive brachytherapy procedures

• Ring implants or intravaginal cones for the relief of excessive bleeding allowed

• No prior definitive surgical oncologic procedures (e.g., radical hysterectomy)

• Concurrent chemotherapy, immunotherapy, or hormonal therapy allowed

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

Radiation:
• brachytherapy

• radiation therapy

Locations

Country	Name	City	State
United States	Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility			No
Primary	Comparison of dose-volume estimations based on 3D imaging-based treatment planning, with the traditional point dose method based on orthogonal radiographs			No
Secondary	Tolerance			Yes
Secondary	Toxicity			Yes
Secondary	Correlate three-dimensional dose-volume histograms of organs at risk with treatment toxicity			Yes
Secondary	Disease status			No
Secondary	Time and patterns of relapse			No
Secondary	Survival distributions			No