- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01627288
Integrated Dose Escalation for Advanced, Localized Gynecologic Cancer (The IDEAL - GYN Trial) (IDEAL)
4. februar 2021 oppdatert av: Duke University
The purpose of this study is to determine the maximum tolerated dose of integrated boost radiation therapy when given with concurrent chemotherapy (cisplatin).
Studieoversikt
Status
Fullført
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
12
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
North Carolina
-
Durham, North Carolina, Forente stater, 27710
- Radiation Oncology, DUMC
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Hunn
Beskrivelse
Inclusion Criteria:
- Biopsy confirmed malignancy of the gynecologic tract
- Involved pelvic or para-aortic lymph nodes
- Treatment plan to include delivery of concurrent chemoradiotherapy.
- Good performance status
- Negative pregnancy test in women of child-bearing potential
- Signed study-specific informed consent
- Lab results within study specific limits
Exclusion Criteria:
- Prior radiation to the abdomen or pelvis
- A history of Scleroderma or Inflammatory bowel disease
- Contraindication to chemotherapy or radiation
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: Boost Radiation: Dose Level 1
2.4 Gy X 25 fractions = 60 Gy
|
Many studies have utilized a sequential boost to deliver a total dose of 55 - 60 Gy to the pelvic sidewall (covering the lower pelvic lymph nodes), including 8-10 Gy that is usually delivered with brachytherapy (1-3).
This study treatment plan will escalate the dose to pelvic and para-aortic nodal disease from 60 Gy in 2.4 Gy per fraction to 70Gy in 2.8 Gy per fraction in 3 dose cohorts, using an integrated boost technique utilizing the same number of fractions for all cohorts (25 fractions) while the elective volumes are held constant at 45Gy
|
Eksperimentell: Boost Radiation: Dose level 2
2.6 Gy X 25 fractions = 65 Gy
|
Many studies have utilized a sequential boost to deliver a total dose of 55 - 60 Gy to the pelvic sidewall (covering the lower pelvic lymph nodes), including 8-10 Gy that is usually delivered with brachytherapy (1-3).
This study treatment plan will escalate the dose to pelvic and para-aortic nodal disease from 60 Gy in 2.4 Gy per fraction to 70Gy in 2.8 Gy per fraction in 3 dose cohorts, using an integrated boost technique utilizing the same number of fractions for all cohorts (25 fractions) while the elective volumes are held constant at 45Gy
|
Eksperimentell: Boost Radiation: Dose level 3
2.8 Gy x 25 fractions = 70 Gy
|
Many studies have utilized a sequential boost to deliver a total dose of 55 - 60 Gy to the pelvic sidewall (covering the lower pelvic lymph nodes), including 8-10 Gy that is usually delivered with brachytherapy (1-3).
This study treatment plan will escalate the dose to pelvic and para-aortic nodal disease from 60 Gy in 2.4 Gy per fraction to 70Gy in 2.8 Gy per fraction in 3 dose cohorts, using an integrated boost technique utilizing the same number of fractions for all cohorts (25 fractions) while the elective volumes are held constant at 45Gy
|
Eksperimentell: Experimental: Boost Radiation Dose Level 0
If the 2 dose limiting toxicities are documented at dose level 1, therapy will be de-escalated to Dose level 0 defined below. Dose level 0: 2.2 Gy X 25 fractions = 55 Gy |
Many studies have utilized a sequential boost to deliver a total dose of 55 - 60 Gy to the pelvic sidewall (covering the lower pelvic lymph nodes), including 8-10 Gy that is usually delivered with brachytherapy (1-3).
This study treatment plan will escalate the dose to pelvic and para-aortic nodal disease from 60 Gy in 2.4 Gy per fraction to 70Gy in 2.8 Gy per fraction in 3 dose cohorts, using an integrated boost technique utilizing the same number of fractions for all cohorts (25 fractions) while the elective volumes are held constant at 45Gy
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Maximum Tolerated Dose of Integrated Boost Radiation Therapy, Administered With IMRT Technique With Concurrent Chemotherapy (Cisplatin).
Tidsramme: During RT to 6 weeks post RT
|
Concurrent radiation therapy and chemotherapy is the standard of care for node positive cervical cancer.
While there are several acceptable means to boost the disease in the low pelvis (i.e.
brachytherapy, IMRT, or external beam), there is limited research into boosting gross disease in the pelvis or para-aortic region.
This protocol is designed to determine the maximum tolerated dose of treating tumor bearing regions within the abdomen and pelvis, using an integrated boost technique and concurrent chemotherapy.
|
During RT to 6 weeks post RT
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Time to Local-regional Control With Integrated Boost Radiation Therapy (TTLR)
Tidsramme: 3 years following treatment
|
Local-regional control is defined as local control without any nodal recurrence.
|
3 years following treatment
|
Time to Distant Recurrence (TTDR)
Tidsramme: 3 years after treatment
|
3 years after treatment
|
|
Disease Free Survival (DFS)
Tidsramme: 3 years after treatment
|
3 years after treatment
|
|
Overall Survival (OS)
Tidsramme: 3 years after treatment
|
3 years after treatment
|
|
Number of Participants With Acute Dose Limiting Toxicities (DLT)
Tidsramme: 6 weeks following treatment
|
Acute DLT will be defined based on the side effects inherent from radiation therapy for gynecologic cancers, including effects on bowel, bladder, and skin.Since integrated radiation dose escalation is unlikely to substantially affect the hematopoietic system, only non-hematologic, grade 3-4, acute toxicity will be considered the primary dose-limiting toxicity (acute DLT).
Dose limiting toxicity will include any of the following during treatment or within 6 weeks of completion: Acute Grade 3-4 enteritis or proctitis, Acute Grade 3-4 bladder toxicity, Acute Grade 4 dermatologic toxicity.
|
6 weeks following treatment
|
Number of Participants With Late Dose Limiting Toxicities (DLT)
Tidsramme: 3 years following treatment
|
Late DLTs will be defined at grade 3-4 GI or GU toxicity with onset after 6 weeks of treatment.
|
3 years following treatment
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Junzo Chino, MD, Duke Cancer Center/Radiation Oncology
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
4. juni 2012
Primær fullføring (Faktiske)
16. november 2018
Studiet fullført (Faktiske)
16. november 2019
Datoer for studieregistrering
Først innsendt
21. juni 2012
Først innsendt som oppfylte QC-kriteriene
22. juni 2012
Først lagt ut (Anslag)
25. juni 2012
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
8. februar 2021
Siste oppdatering sendt inn som oppfylte QC-kriteriene
4. februar 2021
Sist bekreftet
1. februar 2021
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- Pro00033820
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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