A Phase II Study of Extended Field IMRT External Beam Irradiation and Intracavitary Brachytherapy

Stopped early · Phase 2

Conditions studied: Cervical Cancer

In brief

Recent studies have shown that the chance of survival among women with advanced cervical cancer is increased when they receive concurrent chemotherapy and radiation to the pelvis. However, patients who have advanced disease show loco-regional failure as well as a high incidence of distant metastasis. Positron emission tomography (PET) scanning has high sensitivity and specificity in the detection of pelvic and para-aortic lymph node metastases. While the detection of para-aortic metastases by PET significantly impacts prognosis, PET has been known to show positive lymph node metastasis in the pelvis only while not detecting micrometastatic disease in the para-aortic lymph nodes (despite the fact that they are histologically known). In addition, patients with positive para-aortic lymph nodes on PET, greater amounts (more than 45 Gy) of radiation must be used to improve the probability of controlling the cancer. However, doses greater than this have been limited because of the dose and volume limits to the small bowel. But, Intensity Modulated Radiation Therapy (IMRT) is a new way of calculating and delivering radiation therapy. Compared to external beam radiation, IMRT has the improved ability to deliver large doses of radiation to specific targets while minimizing the exposure to surrounding normal tissue. With IMRT, however, the effective dose/volume can be increased more safely and lower the toxicity of surrounding tissue, thus making prophylactic dosing to para-aortic lymph nodes not detected by PET safer and more effective.

Key facts

Study ID: NCT00590967
Run by: Washington University School of Medicine
People needed: 69
Starts: 2003-05-01
Expected to finish: 2013-01-01
Last updated by the study team: 2016-08-29

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

Patients must have carcinoma of the uterine cervix.
Patients with squamous cell, adenocarcinoma, and adenosquamous carcinoma are eligible.
International Federation of Gynecology and Obstetrics (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: white blood cells (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.

You may not qualify if…

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

Where it is running

Washington University School of Medicine — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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