Integrated Dose Escalation for Advanced, Localized Gynecologic Cancer (The IDEAL - GYN Trial) (IDEAL Trial)

N/A

Waitlist Available

Led By Junzo Chino, MD

Research Sponsored by Duke University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years following treatment

Awards & highlights

No Placebo-Only Group

Summary

The purpose of this study is to determine the maximum tolerated dose of integrated boost radiation therapy when given with concurrent chemotherapy (cisplatin).

Eligible Conditions

Cervical Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years following treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years following treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years following treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Maximum Tolerated Dose of Integrated Boost Radiation Therapy, Administered With IMRT Technique With Concurrent Chemotherapy (Cisplatin).

Secondary study objectives

Number of Participants With Acute Dose Limiting Toxicities (DLT)

Number of Participants With Late Dose Limiting Toxicities (DLT)

Time to Local-regional Control With Integrated Boost Radiation Therapy (TTLR)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Group I: Experimental: Boost Radiation Dose Level 0Experimental Treatment1 Intervention

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

Group II: Boost Radiation: Dose level 3Experimental Treatment1 Intervention

2.8 Gy x 25 fractions = 70 Gy

Group III: Boost Radiation: Dose level 2Experimental Treatment1 Intervention

2.6 Gy X 25 fractions = 65 Gy

Group IV: Boost Radiation: Dose Level 1Experimental Treatment1 Intervention

2.4 Gy X 25 fractions = 60 Gy

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Boost radiation

2012