NCT00278304

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Sep 2005

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 16, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 18, 2006

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2006

Completed
Last Updated

June 20, 2013

Status Verified

April 1, 2006

First QC Date

January 16, 2006

Last Update Submit

June 18, 2013

Conditions

Cervical Cancer

Keywords

cervical adenocarcinomacervical adenosquamous cell carcinomacervical squamous cell carcinomastage IB cervical cancerstage IIA cervical cancerstage IIB cervical cancerstage III cervical cancerstage IVA cervical cancerstage IVB cervical cancer

Outcome Measures

Primary Outcomes (2)

  • Feasibility

  • Comparison of dose-volume estimations based on 3D imaging-based treatment planning, with the traditional point dose method based on orthogonal radiographs

Secondary Outcomes (6)

  • Tolerance

  • Toxicity

  • Correlate three-dimensional dose-volume histograms of organs at risk with treatment toxicity

  • Disease status

  • Time and patterns of relapse

  • +1 more secondary outcomes

Interventions

brachytherapyRADIATION
radiation therapyRADIATION

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Bethesda, Maryland, 20892-1182, United States

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

BrachytherapyRadiotherapy

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Shervin Karimpour, MD

    NCI - Radiation Oncology Branch; ROB

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

January 16, 2006

First Posted

January 18, 2006

Study Start

September 1, 2005

Study Completion

June 1, 2006

Last Updated

June 20, 2013

Record last verified: 2006-04

Locations

US(1)