N/A
N=12
Integrated Dose Escalation for Advanced, Localized Gynecologic Cancer (The IDEAL - GYN Trial)
Cancer of the Cervix · Cervical Neoplasms
Bottom Line
View on ClinicalTrials.gov: NCT01627288 ↗Enrolled (actual)
12
Serious AEs
25.0%
Results posted
Mar 2020
Primary outcome: Primary: Maximum Tolerated Dose of Integrated Boost Radiation Therapy, Administered With IMRT Technique With Concurrent Chemotherapy (Cisplatin). — 70 Gray (Gy)
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Boost radiation (Radiation)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Duke University
- Primary completion
- Nov 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Tolerated Dose of Integrated Boost Radiation Therapy, Administered With IMRT Technique With Concurrent Chemotherapy (Cisplatin). |
70 | — |
| SECONDARY Time to Local-regional Control With Integrated Boost Radiation Therapy (TTLR) |
1.5; NA; 0.65; 1.52 | — |
| SECONDARY Time to Distant Recurrence (TTDR) |
1.4; NA; 1.2; 1.29 | — |
| SECONDARY Disease Free Survival (DFS) |
1.3; 0.85; 1.05; 1.34 | — |
| SECONDARY Overall Survival (OS) |
1.6; 0.85; 1.08; 1.7 | — |
| SECONDARY Number of Participants With Acute Dose Limiting Toxicities (DLT) |
1; 0; 0; 1 | — |
| SECONDARY Number of Participants With Late Dose Limiting Toxicities (DLT) |
1; 0; 0; 1 | — |
Summary
The purpose of this study is to determine the maximum tolerated dose of integrated boost radiation therapy when given with concurrent chemotherapy (cisplatin).
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01627288). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.