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

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

Study Overview

• Status: Completed
• Conditions: Cervical Neoplasms; Cancer of the Cervix
• Intervention / Treatment: Radiation: Boost radiation

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Radiation Oncology, DUMC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Boost Radiation: Dose Level 1; 2.4 Gy X 25 fractions = 60 Gy	Radiation: Boost radiation; 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
Experimental: Boost Radiation: Dose level 2; 2.6 Gy X 25 fractions = 65 Gy	Radiation: Boost radiation; 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
Experimental: Boost Radiation: Dose level 3; 2.8 Gy x 25 fractions = 70 Gy	Radiation: Boost radiation; 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
Experimental: 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	Radiation: Boost radiation; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Local-regional Control With Integrated Boost Radiation Therapy (TTLR)	Local-regional control is defined as local control without any nodal recurrence.	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)	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)	Late DLTs will be defined at grade 3-4 GI or GU toxicity with onset after 6 weeks of treatment.	3 years following treatment

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Principal Investigator: Junzo Chino, MD, Duke Cancer Center/Radiation Oncology

Study record dates

Study Major Dates

• Study Start (Actual): June 4, 2012
• Primary Completion (Actual): November 16, 2018
• Study Completion (Actual): November 16, 2019

Study Registration Dates

• First Submitted: June 21, 2012
• First Submitted That Met QC Criteria: June 22, 2012
• First Posted (Estimate): June 25, 2012

Study Record Updates

• Last Update Posted (Actual): February 8, 2021
• Last Update Submitted That Met QC Criteria: February 4, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Diseases; Uterine Cervical Neoplasms
• Other Study ID Numbers: Pro00033820

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No