Integrated Dose Escalation for Advanced, Localized Gynecologic Cancer (The IDEAL - GYN Trial) (IDEAL)
4 februari 2021 uppdaterad 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).
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
12
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
North Carolina
-
Durham, North Carolina, Förenta staterna, 27710
- Radiation Oncology, DUMC
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Kvinna
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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
|
|
Experimentell: 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
|
|
Experimentell: 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
|
|
Experimentell: 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
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Maximum Tolerated Dose of Integrated Boost Radiation Therapy, Administered With IMRT Technique With Concurrent Chemotherapy (Cisplatin).
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Time to Local-regional Control With Integrated Boost Radiation Therapy (TTLR)
Tidsram: 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)
Tidsram: 3 years after treatment
|
3 years after treatment
|
|
|
Disease Free Survival (DFS)
Tidsram: 3 years after treatment
|
3 years after treatment
|
|
|
Overall Survival (OS)
Tidsram: 3 years after treatment
|
3 years after treatment
|
|
|
Number of Participants With Acute Dose Limiting Toxicities (DLT)
Tidsram: 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)
Tidsram: 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
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Junzo Chino, MD, Duke Cancer Center/Radiation Oncology
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
4 juni 2012
Primärt slutförande (Faktisk)
16 november 2018
Avslutad studie (Faktisk)
16 november 2019
Studieregistreringsdatum
Först inskickad
21 juni 2012
Först inskickad som uppfyllde QC-kriterierna
22 juni 2012
Första postat (Uppskatta)
25 juni 2012
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
8 februari 2021
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
4 februari 2021
Senast verifierad
1 februari 2021
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- Pro00033820
Läkemedels- och apparatinformation, studiedokument
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