Pelvic IMRT With Tomotherapy: A Phase I Feasibility Study in Post-Hysterectomy Cervical Cancer Patients

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00359866
First received: August 2, 2006
Last updated: January 28, 2014
Last verified: January 2014
  Purpose

Indications for post-hysterectomy radiation therapy (RT) have been well established by clinical data. Adjuvant RT has demonstrated local control and survival benefit. In patients with nodal disease, adjuvant chemotherapy concurrent with radiation has further improved the clinical outcome. The acute hematological and gastrointestinal toxicity of concurrent chemo-radiotherapy can be quite high, sometimes preventing patients from completed their full treatment course, potentially compromising the therapeutic benefit of treatment. Intensity modulated radiation therapy (IMRT) is an advanced method of delivering external beam radiation that may minimize the volume of normal tissue irradiated to high dose and thus decrease the risk of normal tissue toxicity. Helical tomotherapy is a novel treatment device with sophisticated imaging and treatment delivery features that are optimally suited for IMRT. There are retrospective clinical data supporting the use of non-tomotherapy delivered IMRT to treat patients with gynecologic cancers. The proposed study will prospectively test whether helical tomotherapy is a feasible method for delivering IMRT in post-hysterectomy cervical cancer patients receiving adjuvant RT. Here, the question of feasibility is simply one of verifying that target volumes are reliably covered by 'sculpted' IMRT high-dose regions. Although this is not a treatment effectiveness study, we will also follow the clinical outcome of these patients, including toxicity, local control and survival, in anticipation that this information will be valuable if the treatment modality is judged feasible and will be used for further treatments of this patient population.


Condition Intervention Phase
Uterine Cervical Neoplasms
Radiation: IMRT with tomotherapy
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pelvic IMRT With Tomotherapy: A Phase I Feasibility Study in Post-Hysterectomy Cervical Cancer Patients

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • Determine the feasibility of using helical tomotherapy to deliver IMRT [ Time Frame: After all patients are enrolled and complete treatment ] [ Designated as safety issue: No ]
    Feasibility is defined as the ability to deliver 95% of the prescription dose to 90% of the original planning target volume in at least 90% of the patients, as verified by actual dose delivered calculations using on board CT scan.


Secondary Outcome Measures:
  • Measure the acute toxicity [ Time Frame: Up through 30 days after completion of treatment ] [ Designated as safety issue: Yes ]
  • Measure the late toxicity [ Time Frame: Starting 30 days from completion of treatment through 1 year post start of treatment ] [ Designated as safety issue: Yes ]
  • Measure the local, regional, and distant recurrence rates [ Time Frame: 5 years after completion of treatment ] [ Designated as safety issue: No ]
  • Measure the 5-year disease free and 5-year overall survival rates [ Time Frame: 5 years after completion of treatment ] [ Designated as safety issue: No ]

Enrollment: 28
Study Start Date: February 2006
Estimated Study Completion Date: July 2015
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pelvic IMRT with Tomotherapy

Helical tomotherapy will be used to plan and deliver the radiation treatment.

Treatment volume will include the upper third of the vagina and para-vaginal tissue and the common, external and internal iliac nodal regions.

External beam radiation will be delivered in 160-180 cGy daily fractions to a total dose of 4500-5120 cGY.

Receive treatment once a day for five days a week for approximately 6 weeks.

Treating physician will make determination if patient is to receive intracavitary brachytherapy.

Treating physician will make determination if patient is to receive chemotherapy (allowed but not mandated).

Radiation: IMRT with tomotherapy

Detailed Description:

Patients with cervical cancer receiving post-operative radiotherapy (RT) for high risk features found on pathologic review will be treated with pelvic intensity modulated radiation therapy (IMRT). Helical tomotherapy will be used to plan and deliver the radiation treatment. Treatment volume will include the upper third of the vagina and para-vaginal tissue and the common, external and internal iliac nodal regions. External beam radiation will be delivered in 180 cGy daily fractions to a total dose of 5040 cGy. Patients will receive once a day treatment five days a week, for approximately 6 weeks. Concurrent chemotherapy and/or intracavitary brachytherapy may be included in the treatment plan at the discretion of the treating physician, consistent with routine clinical practice.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age >= 18
  • Karnofsky Performance Status of >= 60
  • FIGO Stage I -IIB
  • Pathologic confirmation of cervical cancer
  • Status post hysterectomy
  • Patients with local or regional metastases are eligible for this protocol, but not those with distant metastases

Exclusion Criteria:

  • Age < 18
  • Karnofsky Performance Status < 60
  • Radiographic or pathologic evidence of distant metastatic disease
  • Prior pelvic radiation therapy, other than trans-vaginal ring brachytherapy irradiation for acute hemostasis
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00359866

Locations
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Perry W Grigsby, M.D. Washington University Medical School
  More Information

Additional Information:
No publications provided

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00359866     History of Changes
Other Study ID Numbers: 05-0977 / 201104019
Study First Received: August 2, 2006
Last Updated: January 28, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Neoplasms
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on April 22, 2014