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

Duke University

Status: Completed

Conditions: Cervical Neoplasms; Cancer of the Cervix

Treatments: Radiation: Boost radiation

Study type: Interventional

Funder types: Other

Identifiers

NCT01627288

Pro00033820

Details and patient eligibility

About

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

Enrollment: 12 patients

Sex: Female

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 4 patient groups

Boost Radiation: Dose Level 1

Experimental group

Description:

2.4 Gy X 25 fractions = 60 Gy

Treatment:

Radiation: Boost radiation

Boost Radiation: Dose level 2

Experimental group

Description:

2.6 Gy X 25 fractions = 65 Gy

Treatment:

Radiation: Boost radiation

Boost Radiation: Dose level 3

Experimental group

Description:

2.8 Gy x 25 fractions = 70 Gy

Treatment:

Radiation: Boost radiation

Experimental: Boost Radiation Dose Level 0

Experimental group

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

Treatment:

Radiation: Boost radiation