Integrated Dose Escalation for Advanced, Localized Gynecologic Cancer (The IDEAL - GYN Trial)
IDEAL
1 other identifier
interventional
12
1 country
1
Brief Summary
The purpose of this study is to determine the maximum tolerated dose of integrated boost radiation therapy when given with concurrent chemotherapy (cisplatin).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2012
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 4, 2012
CompletedFirst Submitted
Initial submission to the registry
June 21, 2012
CompletedFirst Posted
Study publicly available on registry
June 25, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 16, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
November 16, 2019
CompletedResults Posted
Study results publicly available
March 10, 2020
CompletedFebruary 8, 2021
February 1, 2021
6.5 years
June 21, 2012
January 28, 2020
February 4, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Maximum Tolerated Dose of Integrated Boost Radiation Therapy, Administered With IMRT Technique With Concurrent Chemotherapy (Cisplatin).
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
Secondary Outcomes (6)
Time to Local-regional Control With Integrated Boost Radiation Therapy (TTLR)
3 years following treatment
Time to Distant Recurrence (TTDR)
3 years after treatment
Disease Free Survival (DFS)
3 years after treatment
Overall Survival (OS)
3 years after treatment
Number of Participants With Acute Dose Limiting Toxicities (DLT)
6 weeks following treatment
- +1 more secondary outcomes
Study Arms (4)
Boost Radiation: Dose Level 1
EXPERIMENTAL2.4 Gy X 25 fractions = 60 Gy
Boost Radiation: Dose level 2
EXPERIMENTAL2.6 Gy X 25 fractions = 65 Gy
Boost Radiation: Dose level 3
EXPERIMENTAL2.8 Gy x 25 fractions = 70 Gy
Experimental: Boost Radiation Dose Level 0
EXPERIMENTALIf 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
Interventions
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Prior radiation to the abdomen or pelvis
- A history of Scleroderma or Inflammatory bowel disease
- Contraindication to chemotherapy or radiation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Duke Universitylead
Study Sites (1)
Radiation Oncology, DUMC
Durham, North Carolina, 27710, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Jennifer Mewshaw, MS RN
- Organization
- Duke University Health System
Study Officials
- PRINCIPAL INVESTIGATOR
Junzo Chino, MD
Duke Cancer Center/Radiation Oncology
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 21, 2012
First Posted
June 25, 2012
Study Start
June 4, 2012
Primary Completion
November 16, 2018
Study Completion
November 16, 2019
Last Updated
February 8, 2021
Results First Posted
March 10, 2020
Record last verified: 2021-02