search
Back to results

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

Primary Purpose

Cancer of the Cervix, Cervical Neoplasms

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Boost radiation
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cancer of the Cervix

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Radiation Oncology, DUMC

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Boost Radiation: Dose Level 1

Boost Radiation: Dose level 2

Boost Radiation: Dose level 3

Experimental: Boost Radiation Dose Level 0

Arm Description

2.4 Gy X 25 fractions = 60 Gy

2.6 Gy X 25 fractions = 65 Gy

2.8 Gy x 25 fractions = 70 Gy

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Time to Local-regional Control With Integrated Boost Radiation Therapy (TTLR)
Local-regional control is defined as local control without any nodal recurrence.
Time to Distant Recurrence (TTDR)
Disease Free Survival (DFS)
Overall Survival (OS)
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.
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.

Full Information

First Posted
June 21, 2012
Last Updated
February 4, 2021
Sponsor
Duke University
search

1. Study Identification

Unique Protocol Identification Number
NCT01627288
Brief Title
Integrated Dose Escalation for Advanced, Localized Gynecologic Cancer (The IDEAL - GYN Trial)
Acronym
IDEAL
Official Title
Integrated Dose Escalation for Advanced, Localized Gynecologic Cancer (The IDEAL - GYN Trial)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
June 4, 2012 (Actual)
Primary Completion Date
November 16, 2018 (Actual)
Study Completion Date
November 16, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer of the Cervix, Cervical Neoplasms

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Boost Radiation: Dose Level 1
Arm Type
Experimental
Arm Description
2.4 Gy X 25 fractions = 60 Gy
Arm Title
Boost Radiation: Dose level 2
Arm Type
Experimental
Arm Description
2.6 Gy X 25 fractions = 65 Gy
Arm Title
Boost Radiation: Dose level 3
Arm Type
Experimental
Arm Description
2.8 Gy x 25 fractions = 70 Gy
Arm Title
Experimental: Boost Radiation Dose Level 0
Arm Type
Experimental
Arm Description
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
Intervention Type
Radiation
Intervention Name(s)
Boost radiation
Intervention Description
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
Primary Outcome Measure Information:
Title
Maximum Tolerated Dose of Integrated Boost Radiation Therapy, Administered With IMRT Technique With Concurrent Chemotherapy (Cisplatin).
Description
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.
Time Frame
During RT to 6 weeks post RT
Secondary Outcome Measure Information:
Title
Time to Local-regional Control With Integrated Boost Radiation Therapy (TTLR)
Description
Local-regional control is defined as local control without any nodal recurrence.
Time Frame
3 years following treatment
Title
Time to Distant Recurrence (TTDR)
Time Frame
3 years after treatment
Title
Disease Free Survival (DFS)
Time Frame
3 years after treatment
Title
Overall Survival (OS)
Time Frame
3 years after treatment
Title
Number of Participants With Acute Dose Limiting Toxicities (DLT)
Description
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.
Time Frame
6 weeks following treatment
Title
Number of Participants With Late Dose Limiting Toxicities (DLT)
Description
Late DLTs will be defined at grade 3-4 GI or GU toxicity with onset after 6 weeks of treatment.
Time Frame
3 years following treatment

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Junzo Chino, MD
Organizational Affiliation
Duke Cancer Center/Radiation Oncology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Radiation Oncology, DUMC
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs