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

Not Applicable

Completed

• Conditions: Cervical Neoplasms; Cancer of the Cervix
• Interventions: Radiation: Boost radiation

• Registration Number: NCT01627288
• Lead Sponsor: Duke University

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2012-06-04
• Study First Submitted: 2012-06-21
• Study First Submitted QC: 2012-06-22
• Study First Posted: 2012-06-25
• Primary Completion: 2018-11-16
• Study Completion: 2019-11-16
• Results First Submitted: 2020-01-28
• Results First Submitted QC: 2020-02-25
• Results First Posted: 2020-03-10
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-04
• Last Update Posted: 2021-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 12

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

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Exclusion Criteria

• Prior radiation to the abdomen or pelvis
• A history of Scleroderma or Inflammatory bowel disease
• Contraindication to chemotherapy or radiation

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Boost Radiation: Dose level 2	Boost radiation	2.6 Gy X 25 fractions = 65 Gy
Boost Radiation: Dose level 3	Boost radiation	2.8 Gy x 25 fractions = 70 Gy
Boost Radiation: Dose Level 1	Boost radiation	2.4 Gy X 25 fractions = 60 Gy
Experimental: Boost Radiation Dose Level 0	Boost radiation	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

Primary Outcome Measures

Name	Time	Method
Maximum Tolerated Dose of Integrated Boost Radiation Therapy, Administered With IMRT Technique With Concurrent Chemotherapy (Cisplatin).	During RT to 6 weeks post RT	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

Name	Time	Method
Number of Participants With Acute Dose Limiting Toxicities (DLT)	6 weeks following treatment	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.
Disease Free Survival (DFS)	3 years after treatment
Overall Survival (OS)	3 years after treatment
Number of Participants With Late Dose Limiting Toxicities (DLT)	3 years following treatment	Late DLTs will be defined at grade 3-4 GI or GU toxicity with onset after 6 weeks of treatment.
Time to Local-regional Control With Integrated Boost Radiation Therapy (TTLR)	3 years following treatment	Local-regional control is defined as local control without any nodal recurrence.
Time to Distant Recurrence (TTDR)	3 years after treatment

Trial Locations

Locations (1)

Radiation Oncology, DUMC; 🇺🇸 Durham, North Carolina, United States