Pelvic IMRT With Tomotherapy: A Phase I Feasibility Study in Post-Hysterectomy Cervical Cancer Patients
13. juni 2016 opdateret af: Washington University School of Medicine
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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
28
Fase
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Missouri
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St. Louis, Missouri, Forenede Stater, 63110
- Washington University School of Medicine
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Kvinde
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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). |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Determine the feasibility of using helical tomotherapy to deliver IMRT
Tidsramme: After all patients are enrolled and complete treatment
|
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
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Measure the acute toxicity
Tidsramme: Up through 30 days after completion of treatment
|
Up through 30 days after completion of treatment
|
|
Measure the late toxicity
Tidsramme: Starting 30 days from completion of treatment through 1 year post start of treatment
|
Starting 30 days from completion of treatment through 1 year post start of treatment
|
|
Measure the local, regional, and distant recurrence rates
Tidsramme: 5 years after completion of treatment
|
5 years after completion of treatment
|
|
Measure the 5-year disease free and 5-year overall survival rates
Tidsramme: 5 years after completion of treatment
|
5 years after completion of treatment
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Perry W Grigsby, M.D., Washington University Medical School
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. februar 2006
Primær færdiggørelse (Faktiske)
1. juli 2010
Studieafslutning (Faktiske)
1. januar 2016
Datoer for studieregistrering
Først indsendt
2. august 2006
Først indsendt, der opfyldte QC-kriterier
2. august 2006
Først opslået (Skøn)
3. august 2006
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
15. juni 2016
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
13. juni 2016
Sidst verificeret
1. juni 2016
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 05-0977 / 201104019
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .