Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Uterine Cervical Neoplasms

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Antineoplastic Agents

All Drugs and Chemicals

Cisplatin

Pelvic Lymph Nodes Only Positive on FDG PET.

IMRT External Beam radiation to the para-aortic region (45 Gy)

Pelvis intracavitary brachytherapy (6 HDR treatments)

Weekly cisplatin 40 mg/m\^2

Para-Aortic Lymph Nodes Positive on FDG PET

IMRT (50.4 Gy to para-aortic lymph node bed with a 10.8 Gy boost to nodes)

IMRT external beam pelvic radiation therapy as appropriate for stage

Intracavitary brachytherapy (6 HDR treatments)

Weekly cisplatin (40 mg/m\^2)

IMRT extended field external beam radiation therapy

Brachytherapy

Perry Grigsby, MD

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.

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 fluorodeoxyglucose (FDG) PET scan and must include evaluation of para-aortic lymph nodes. Blood work will be done (complete blood count (CBC), differential, platelets, blood urea nitrogen(BUN), serum creatinine, bilirubin, aspartate aminotransferase (AST), alanine aminotransferase (ALT) and alkaline phosphatase. Also, pre-treatment, patients will receive a chest x-ray and an intravenous push (IVP) (unless a computed tomography (CT) with contrast has been performed). Additionally, patient may undergo a CT, magnetic resonance (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 Group 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 high dose radiation (HDR) treatments) concurrently with cisplatin (40 mg/m\^2/week)

Treatment Group 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/m\^2/week).

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

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

-The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for all toxicity reporting.

Washington University School of Medicine

Serious adverse events are events that had serious adverse event reports filed with the institutional review board.

Pelvic Lymph Nodes Only Positive on FDG PET.

IMRT External Beam radiation to the para-aortic region (45 Gy)

Pelvis intracavitary brachytherapy (6 HDR treatments)

Weekly cisplatin (40 mg/m\^2)

Treatment Group 1 (IMRT, Brachytherapy, Cisplatin)

Treatment Group 2 (IMRT, Brachytherapy, Cisplatin)

Total

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

Perry Grigsby, M.D.

Neutropenia

Anorexia

Diarrhea

Hypomagnesemia

Leukopenia

Lymphopenia

Dyspnea

Fatigue

Hemoglobin

Hematocrit

Hyperkalemia

Hypoglycemia

Hyponatremia

Infection without neutropenia

Platelets

Renal failure

Tolerance of IMRT Extended-field External Radiotherapy to Pelvis and Para-aortic Region, Combined With Intracavitary Irradiation, and Cisplatin Chemotherapy as Measured the Number of Participants With by Grade 4 or Higher Toxicity

Absolute neutrophil count

Anxiety

Dysuria

Granulocytes/bands

Vaginal bleeding

Hyperglycemia

Hypermagnesemia

Hypertension

Hypocalcemia

Hypokalemia

Infection with neutropenia

Infection (Urinalysis)

Nausea

Abdominal pain

Pelvic pain

Pain - not otherwise specified (NOS)

packed red blood cell (PRBC) Transfusion

Proteinuria

Skin

Vomiting

Weight loss

Albumin

Atrial fibrillation

Confusion

Creatinine

Vaginal mucosa erythematous

Edema

erythrocyte sedimentation rate (ESR)

international normalized ratio (INR)

Leucocyte esterase

Prothrombin time (PT)

partial thromboplastin time (PTT)

aspartate aminotransferase (ALT)

Yeast infection

Number of Participants With Acute Toxicity of IMRT Extended-field External Radiotherapy to Pelvis and Para-aortic Region, Combined With Intracavitary Irradiation, and Cisplatin Chemotherapy (Grade 3 or Higher)

Positive PET scan

Negative PET scan

Equivocal PET scan

PET scan not performed

Efficacy of IMRT Extended-field Radiation Combined With Intracavitary Irradiation, and Cisplatin Chemotherapy as Measured by PET Scan Disease Status

The data was not collected for this secondary outcome. Due to the the early termination of this study, only data for the primary outcomes were collected and analyzed.

Efficacy of IMRT to the Para-aortic Lymph Nodes, IMRT External Beam Radiotherapy to the Pelvis, Intracavitary Irradiation, and Cisplatin Chemotherapy as Measured by the Frequency of Distant Metastasis

Pelvic Lymph Nodes Only Positive on fluorodeoxyglucose (FDG) positron emission tomography (PET).

Intensity-modulated radiation therapy (IMRT) External Beam radiation to the para-aortic region (45 Gy)

Pelvis intracavitary brachytherapy (6 high dose radiation (HDR) treatments)

Weekly cisplatin 40 mg/m\^2

Overall Study

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Phase II Study of Extended Field IMRT External Beam Irradiation and Intracavitary Brachytherapy	NCT00590967	Cervical Cancer	IMRT extended f... Brachytherapy Cisplatin	18 Years -	Washington University School of Medicine
A Phase II Study of Extended Field IMRT External Beam Irradiation and Intracavitary Brachytherapy	NCT00590967	Cervical Cancer	IMRT extended f... Brachytherapy Cisplatin	18 Years -	Washington University School of Medicine
A Phase II Study of Extended Field IMRT External Beam Irradiation and Intracavitary Brachytherapy	NCT00590967	Cervical Cancer	IMRT extended f... Brachytherapy Cisplatin	18 Years -	Washington University School of Medicine

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