Integrated Dose Escalation for Advanced, Localized Gynecologic Cancer (The IDEAL - GYN Trial)
Conditions
Cancer of the Cervix - Cervical Neoplasms
Conditions: official terms
Uterine Cervical Neoplasms
Study Type
Interventional
Study Phase
N/A
Study Design
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Boost radiation
Type: Radiation
Overall Status
Recruiting
Summary
The purpose of this study is to determine the maximum tolerated dose of integrated boost radiation therapy when given with concurrent chemotherapy (cisplatin).
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Female
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
Location
Radiation Oncology, DUMC
Durham, North Carolina, United States
Status: Recruiting
Contact: Junzo Chino, MD - 919-668-7336 - junzo.chino@dm.duke.edu
Start Date
June 2012
Completion Date
June 2020
Sponsors
Duke University
Source
Duke University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page