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Study Summary
No. RTOG0417:.......Cervix......Anuja Jhingran......Radiation Oncology
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Study Summary Title
Study Summary
Number:
RTOG0417
Study Title:A Phase II Study Of Bevacizumab In Combination With Definitive Radiotherapy And Cisplatin Chemotherapy In Untreated Patients With Locally Advanced Cervical Carcinoma
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Physician New Patient Referral
Name:Anuja JhingranPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:Radiation OncologyReferring MD
Call:
800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-563-6830
Contact us about clinical trials
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General Information
Disease Group:CervixSupported By:N/A
Phase of Study:Phase IIReturn
Visit:
Follow-up at 4-6 weeks post chemoradiation treatment; then q 3 months for the
first 2 years; q 4 months during 3rd year and q 6 months at 4-5 years and then
annually. CT/MRI/PET CT at 4-6 weeks post RT; tumor response assessment q
follow-up visit.
Treatment
Agents:
Bevacizumab
Cisplatin
Radiation
Home Care:NA
Treatment Loc:Independent Multicenter Arrangements
Estimated
Length of Stay
in Houston:
N/A
Description/
Intervention:
The goal of this clinical research study is to learn the side effects of giving
a combination of the chemotherapy drugs bevacizumab and cisplatin, along with
radiation, to treat locally advanced cervical cancer. Researchers also want to
learn if this treatment combination can help to control the disease.
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Study Objectives / Outcomes
Primary:
1. To determine treatment-related serious adverse event rates and adverse event rates, within first 90 days from treatment start, in patients with locally advanced carcinoma of the cervix treated by intravenous bevacizumab, intravenous weekly cisplatin and concurrent pelvic radiation therapy.

Secondary:
1. To evaluate treatment-related serous adverse events & adverse events at any time;
2. To evaluate disease-free survival (failure: local, regional or distant failure, or death due to any cause);
3. To evaluate overall survival (failure: death due to any cause);
4. To collect tissue to perform future immunohistochemical analyses for angiogenic markers to correlate with clinical outcome; to collect tissue to perform future microarray testing for evaluation of gene expression;
5. To collect urine and serum for future cytokine analysis;
6. To implement the image-based brachytherapy guidelines proposed by the Transatlantic Image-guided Brachytherapy Working Group and collect CT or MRI-based dosimetry of brachytherapy applications used during the course of treatment for later analysis of feasibility and consistency as well as dose/volume assessments of tumor control and complications.
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Study Status Information
Study Activation / Registration Date:06/14/2007
IRB Review and Approval Date:06/14/2007
Study Type:Phase Ii Or Phase I/Ii
Recruitment Status:Closed
Projected Accrual:57
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Enrollment Eligibility
If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:1) Histologic proof of squamous, adenocarcinoma, or adenosquamous carcinoma of the uterine cervix, including FIGO (International Federation of Gynecologists and Obstetricians) stage IIB to IIIB or patients with FIGO stage IB to IIA who have biopsy-proven pelvic node metastases and/or tumor size greater than or equal to 5 cm.

2) All patients must have confirmation of diagnosis by cervical biopsy.

3) Zubrod Performance Status 0-2.

4) White blood cell count >/= 3,000/mm^3

5) Absolute granulocyte count >/= 1,500/mm^3

6) Platelets >/= 100,000/mm^3

7) Total bilirubin </= 1.5 mg/dl

8) Serum creatinine </= 1.5 mg/dl

9) AST and ALT </= 2.5 x institutional upper normal limit

10) Serum calcium </= 1.3 x institutional upper normal limit

11) INR < 1.5

12) Negative Serum Pregnancy Test

13) Hemoglobin >/= 10 – Transfusion may be used to meet this criterion.

14) Urine protein screening must be performed within 21 days of study entry: (1) If urine analysis for urine protein creatinine (UPC) ratio > 0.5, then a 24-hour urine protein must be performed and must be < 1000 mg; (2) UPC is calculated using: (a) [urine protein]/[urine creatinine] - if both protein & creatinine are reported in mg/dL; (b) [urine protein) x0.088]/[urine creatinine] - if urine creatinine is reported in mmol/L.

15) Chest X-Ray, Chest CT, or PET-CT within 8 weeks prior to study entry

16) Evaluation of para-aortic lymph nodes is required to at least the level of the renal vessels by contrast-enhanced CT, MRI or PET-CT within 8 weeks prior to study entry. All patients with suspicious para-aortic lymph nodes on CT, MRI or PET-CT must have biopsy by fine needle aspirate or laparoscopy or laparotomy. FDG-PET scanning can be used to supplement cross sectional imaging for determination of nodal involvement or distant metastases. PET imaging is encouraged, but not required.

17) CT, MRI or PET-CT of the abdomen/pelvis that must include evaluation of the abdomen to at least the level of the renal vessels, with contrast-enhancement, within 8 weeks prior to study entry. MRI of the pelvis is strongly preferred in order to allow tumor measurement in three dimensions.

18) Signed study-specific informed consent prior to study entry.

19) Blood pressure level of 140/90mmHg.

Exclusion Criteria:1) Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years.

2) Medical illness preventing the use of full-dose chemotherapy.

3) Evidence of bleeding diathesis or coagulopathy, INR > 1.5

4) Patients who require the use of warfarin sodium > 1 mg.

5) Previous medical or psychiatric illness that would prevent informed consent or limit survival to < 6 months.

6) Prior surgery to treat carcinoma of the cervix other than biopsy.

7) Patients who have undergone surgical debulking of pelvic or para-aortic nodes.

8) Patients with positive para-aortic disease

9) Previous pelvic radiation therapy including transvaginal irradiation to control bleeding.

10) Prior systemic chemotherapy.

11) Patients with active GI ulcers, GI bleeding, or active inflammatory bowel disease.

12) Pregnant, nursing or woman of childbearing potential who are sexually active and not willing/able to use medically acceptable forms of contraception.

13) Clinically significant cardiac disease (e.g., uncontrolled hypertension [blood pressure of > 160/90 mmHg on medication], history of myocardial infarction or unstable angina within 12 months of registration), New York Heart Association (NYHA) Class II or greater congestive heart failure, unstable symptomatic arrhythmia requiring medication (subjects with chronic atrial arrhythmia, i.e., atrial fibrillation or paroxysmal supraventricular tachycardia) are not eligible.

14) Patients with a history of aneurysms, cerebrovascular accident (CVA) and arteriovenous malformations

15) Patients with arterial thromboembolic events, including transient ischemic attack (TIA), or clinically significant peripheral artery disease within 6 months of registration.

16) Tumor outside the pelvis.

17) Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to start of treatment, or anticipation of need for major surgical procedure during the course of the study.

18) Serious, non-healing wound, ulcer, or current healing fracture.

19) Patients with a history of any type of fistula (vesicovaginal, gastrointestinal, etc) or gastrointestinal perforation.

20) Intra-abdominal abscess within 6 months of study entry.

21) Patients who have had an organ transplant.

22) Patients with known hypersensitivity of Chinese hamster ovary cell products or other recombinant human antibodies.

23) Patients who are known to be HIV positive who have a CD4 cell count less than 350 cells/mm^3 within 21 days of registration; note, however, that HIV testing is not required for entry into this protocol. Excluding HIV positive patients with invasive cervical cancer and low CD4 cell counts is necessary because the treatments involved in this protocol may be significantly immunosuppressive.

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Links
Registration Number: NCT00369122
Study Information on Clinical Trials Registry (clinicaltrials.gov)

Other Links:
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Results


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