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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


Phase 2
18 Years
N/A
Not Enrolling
Female
Cervical Cancer

Thank you

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 MedicineSaint Louis, Missouri  63110