Phase I Trial of Dose Escalated IMRT to the Para-aortic Nodes With Concurrent Cisplatin and Amifostine in Locally Advanced Cervical Cancer
19 Years
N/A
Female
Cervical Cancer
Trial Information
Phase I Trial of Dose Escalated IMRT to the Para-aortic Nodes With Concurrent Cisplatin and Amifostine in Locally Advanced Cervical Cancer
This is a Phase I open-label multi-institutional study that will enroll a minimum of 27 and
up to 42 patients with locally advanced cervical cancer (a minimum of 27 will be entered if
all dose levels are explored without reaching a dose limiting toxicity at any level). The
primary objective is to determine the maximum tolerated dose (MTD) of external beam
radiation to the para-aortic lymph nodes using IMRT and amifostine. Patients will be
stratified according to gross tumor volume (GTV) prior to dose escalation.
Within each GTV stratum, the dose escalation will be determined as follows: Accrue 3
patients in the first dose level based on the determined stratum. A Dose Limiting Toxicity
is defined as the development of > Grade 3 acute GI toxicity, per the RTOG acute toxicity
scale. If no DLT is observed at the first dose level, 3 patients will be enrolled at the
next dose level. If one patient experiences DLT at a given dose level, 3 additional
patients will be enrolled at that dose level. If 0 of these 3 additional patients
experience DLT, dosing of the next dose level is begun. If 1 or more of these 3 additional
patients experience DLT at the highest dose level below the maximally administered dose,
this dose becomes the recommended dose. At least 6 patients must be entered at this
recommended dose. The Maximum Tolerated Dose (MTD) is defined as the dose preceding that at
which 2 of 6 patients experience dose limiting toxicity.
Inclusion Criteria:
- No prior therapy other than biopsy of the cervix or endoscopic pelvic nodal
resection.
- Patients may have endoscopic resection of enlarged pelvic and low common iliac nodes,
however, needle biopsy only of enlarged para-aortic nodes will be eligible for entry.
- Patients with squamous cell, adenocarcinoma, and adenosquamous carcinoma are
eligible.
- Patients must have no evidence of metastatic disease outside of the pelvis (except to
the para-aortic nodes).
- Patients must have Zubrod performance status 0-1 and no medical contraindications to
the administration of full dose chemotherapy.
- Patients must have a life expectancy > 6 months
- Adequate bone marrow function: white blood cell (WBC) 3000/mm3 (absolute neutrophil
count [ANC] 1500/mm3); adequate renal function: creatinine 1.5 mg/dl (urinary
diversion is permitted to improve renal function); patients must have bilirubin 1.5
mg/dl, ALT 2 x normal.
- No prior (within last 3 years) or simultaneous malignancies (other than basal cell or
non-invasive tumors)
Exclusion Criteria:
- Complete resection of the involved para-aortic nodes.
- Patients with evidence of bowel adherent to the GTV by contrast enhanced computed
tomography (CT) scan will be ineligible.
- Patients with the following histologies will be ineligible: glassy cell, small cell,
carcinoid, adenoid cystic, and clear cell.
- Prior (within last 3 years) malignancies other than basal cell carcinoma or
non-invasive malignancies.
- Prior chemotherapy.
- Prior pelvic or abdominal radiation (other than transvaginal irradiation to control
bleeding).
- Prior tumor-directed surgery other than lymph node sampling/staging
- Life expectancy < 6 months
- Patients who are pregnant will be ineligible.
- Patients with insulin dependent diabetes will be ineligible.
- Patients who are obese, such that reliable immobilization is not achieved.
- Patients with pain or discomfort that would preclude lying still for extended periods
of time.
- Patients with tumors that are bleeding and require more immediate treatment.
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
The primary objective is to determine the maximum tolerated dose (MTD) of external beam radiation to the para-aortic lymph nodes using IMRT and amifostine.
Principal Investigator
Jennifer F De Los Santos, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of Alabama at Birmingham
Authority:
United States: Institutional Review Board
Study ID:
ETH175-04D
NCT ID:
NCT00137358
Start Date:
Completion Date:
Related Keywords:
- Cervical Cancer
- Cervical
- Uterine
- Para-aortic
- Nodes
- IMRT
- Cancer
- Uterine Cervical Neoplasms
Name | Location |
|---|---|
| University of Alabama at Birmingham | Birmingham, Alabama 35294-3300 |
