A Phase II Study of Extended Field IMRT External Beam Irradiation and Intracavitary Brachytherapy With Concurrent Weekly Cisplatin in Patients With Stage I-IVA Cervical Cancer Who Have FDG PET Positive Pelvic or Para-Aortic Lymph Nodes
18 Years
N/A
Female
Cervical Cancer
Trial Information
A Phase II Study of Extended Field IMRT External Beam Irradiation and Intracavitary Brachytherapy With Concurrent Weekly Cisplatin in Patients With Stage I-IVA Cervical Cancer Who Have FDG PET Positive Pelvic or Para-Aortic Lymph Nodes
Prior to entrance on the study, patients will undergo a history and physical and evaluation
of Karnofsky Performance Status. They will have a biopsy of their tumor and will undergo a
FDG PET scan and must include evaluation of para-aortic lymph nodes. Blood work will be
done (CBC, differential, platelets. BUN, serum creatinine, bilirubin, AST, ALT and alkaline
phosphatase. Also, pre-treatment, patients will receive a chest x-ray and an IVP (unless a
CT with contrast has been performed). Additionally, patient may undergo a CT, MRI and/or
lymphangiogram.
Patients will then be registered to a treatment arm, depending on the outcome of their PET
scan. Patients with positive pelvic lymph nodes but no positive para-aortic lymph nodes by
PET will be assigned to Treatment Arm 1. Patients with positive pelvic lymph nodes and
positive para-aortic lymph nodes by PET will be assigned to treatment arm 2.
Treatment Arm 1. Either a conventional or CT simulation may be performed. Patients will be
treated with IMRT extended field external beam radiation therapy (to cover pelvis and
para-aortic lymph nodes) and intracavitary radiation (6 HDR treatments) concurrently with
cisplatin (40 mg/m2/week)
Treatment Arm 2. A CT simulation must be performed. Patients will be treated with extended
field external beam radiation therapy to the pelvis and with IMRT to cover the para-aortic
lymph nodes to 60 Gy, 50.4 Gy to the para-aortic lymph node bed in conjunction with external
beam pelvic radiation therapy as appropriate for disease stage and intracavitary radiation
(6 HDR treatments) concurrently with cisplatin (40 mg/m2/week).
Inclusion Criteria:
- Patients must have carcinoma of the uterine cervix.
- Patients with squamous cell, adenocarcinoma, and adenosquamous carcinoma are
eligible.
- FIGO Stage I to IVA
- Patients must have no evidence of metastatic disease outside of the pelvis (except to
the para-aortic nodes), by PET.
- Patients must have a Karnofsky Performance Status of >= 60 and no medical
contraindications to the administration of chemotherapy.
- Age >= 18.
- Adequate bone marrow function: WBC >= 4000/mm3, platelets >= 100,000 mm3.
- Adequate renal function: BUN <= 25 mg/dl, creatinine <= 1.2 mg/dl (urinary diversion
is permitted to improve renal function).
- Patients must have bilirubin <= 1.5 mg/dl.
- Signed study-specific informed consent.
Exclusion Criteria:
- No positive lymph nodes by FDG PET
- Positive supraclavicular lymph nodes by FDG PET Scan or evidence of more distant
disease.
- FIGO Stage IVB+ Cervical Cancer
- No prior (within 5 years) or simultaneous malignancies (other than cutaneous basal
cell carcinoma).
- Karnofsky Performance Status <60.
- Patients with significant medical illness preventing the use of full dose
chemotherapy are excluded.
- Patients with the following histologies are excluded: small cell, carcinoid, glassy
cell, clear cell and adenoid cystic.
- Life expectancy < 6 months.
- Patients with poorly controlled diabetes mellitus (fasting blood glucose level > 200
mg/dL) are not eligible.
- No prior surgery for treatment of disease other than exploratory laparotomy or
biopsy.
- No previous systemic chemotherapy.
- No pelvic radiation therapy is permitted other than transvaginal irradiation to
control bleeding.
- Pregnant women are ineligible and those of child-bearing potential should practice
contraception.
- Patients with abnormal liver function tests
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Group 1 - Tolerance, acute toxicity and efficacy of IMRT extended-field external radiotherapy to pelvis and para-aortic region, combined with intracavitary irradiation, and cisplatin chemotherapy.
Outcome Time Frame:
5 years of followup
Safety Issue:
Yes
Principal Investigator
Perry Grigsby, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Washington University School of Medicine
Authority:
United States: Institutional Review Board
Study ID:
03-0300 / 201105362
NCT ID:
NCT00590967
Start Date:
April 2003
Completion Date:
January 2013
Related Keywords:
- Cervical Cancer
- para-aortic lymph nodes
- Uterine Cervical Neoplasms
Name | Location |
|---|---|
| Washington University School of Medicine | Saint Louis, Missouri 63110 |
