Overview

This trial is active, not recruiting.

Conditions cancer of the cervix, cervical neoplasms
Treatment boost radiation
Sponsor Duke University
Start date June 2012
End date August 2017
Trial size 12 participants
Trial identifier NCT01627288, Pro00033820

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
2.4 Gy X 25 fractions = 60 Gy
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
(Experimental)
2.6 Gy X 25 fractions = 65 Gy
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
(Experimental)
2.8 Gy x 25 fractions = 70 Gy
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
(Experimental)
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
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

Primary Outcomes

Measure
Maximum tolerated dose of integrated boost radiation therapy, administered with IMRT technique with concurrent chemotherapy (cisplatin).
time frame: 3 years after treatment

Secondary Outcomes

Measure
Local-regional control with integrated boost radiation therapy (TTLR)
time frame: 3 years following treatment
Time to distant recurrence (TTDR)
time frame: 3 tears after treatment
Disease free survival(DFS).
time frame: 3 years after treatment
Overall survival (OS)
time frame: 3 years after treatment
The number of acute dose limiting toxicities (DLT).
time frame: 6 weeks following treatment
The number of late dose limiting toxicities (DLT)
time frame: 3 years following treatment

Eligibility Criteria

Female participants at least 18 years old.

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

Additional Information

Official title Integrated Dose Escalation for Advanced, Localized Gynecologic Cancer (The IDEAL - GYN Trial)
Principal investigator Junzo Chino, MD
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Duke University.
Location data was received from the National Cancer Institute and was last updated in August 2016.