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

NCT00359866 | Completed Phase 1

• 1 other identifier: 05-0977 / 201104019
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Uterine Cervical Neoplasms

Outcome Measures

Primary Outcomes (1)

• Determine the feasibility of using helical tomotherapy to deliver IMRT

  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.

  After all patients are enrolled and complete treatment

Secondary Outcomes (4)

• Measure the acute toxicity

  Up through 30 days after completion of treatment

• Measure the late toxicity

  Starting 30 days from completion of treatment through 1 year post start of treatment

• Measure the local, regional, and distant recurrence rates

  5 years after completion of treatment

• Measure the 5-year disease free and 5-year overall survival rates

  5 years after completion of treatment

Study Arms (1)

Pelvic IMRT with Tomotherapy

EXPERIMENTAL

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

Interventions

IMRT with tomotherapy RADIATION

Pelvic IMRT with Tomotherapy

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Radiotherapy, Intensity-Modulated

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, Conformal; Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics

Study Officials

• Perry W Grigsby, M.D.

  Washington University Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2006
• First Posted: August 3, 2006
• Study Start: February 1, 2006
• Primary Completion: July 1, 2010
• Study Completion: January 1, 2016
• Last Updated: June 15, 2016

Record last verified: 2016-06

Locations

US (1)