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

Cancer of the Cervix Clinical Trial

— IDEAL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01627288
• Other study ID #: Pro00033820
• Status: Completed
• Phase: N/A
• Start date: June 4, 2012
• Est. completion date: November 16, 2019

Study information

• Verified date: February 2021
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: November 16, 2019
• Est. primary completion date: November 16, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer of the Cervix
• Cervical Neoplasms
• Uterine Cervical Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	Radiation Oncology, DUMC	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Time to Distant Recurrence (TTDR)		3 years after treatment
Secondary	Disease Free Survival (DFS)		3 years after treatment
Secondary	Overall Survival (OS)		3 years after treatment
Secondary	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
Secondary	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