Phase
Condition
Cervical Cancer
Pelvic Cancer
Vaginal Cancer
Treatment
IMRT
PET-guided Bone Marrow-Sparing Intensity Modulated Radiation Therapy (IMRT)
Cisplatin
Clinical Study ID
Ages > 18 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Biopsy-proven, invasive squamous cell carcinoma, adenocarcinoma, or adenosquamouscarcinoma of the cervix
Biopsy result positive for carcinoma within 60 days prior to registration
FIGO clinical stage I-IVA disease, based on standard diagnostic workup,including:History/physical examination and/or Examination under anesthesia (ifindicated)
If the patient is status post hysterectomy, one or more of the following conditionsmust be present: positive lymph nodes, positive margins, parametrial invasion, ornon-radical surgery (i.e., simple hysterectomy).
If the patient is inoperable, one or more of the following conditions must bepresent: clinical stage IB2-IVA, positive lymph nodes on nodal sampling or frozensection, and/or parametrial invasion
Within 42 days prior to registration, the patient must have any of the following, ifclinically indicated: examination under anesthesia, cystoscopy, sigmoidoscopy, rigidproctoscopy, or colonoscopy.
X-ray (PA and lateral), CT scan, or PET/CT scan of the chest within 42 days prior toregistration;
CT scan, MRI, or PET/CT of the pelvis within 42 days prior to registration;
Karnofsky Performance Status 60-100
Absolute neutrophil count (ANC) ≥ 1500 cells/mm3; Platelets ≥ 100,000 cells/mm3;Hemoglobin ≥ 10.0 g/dl (Note: The use of transfusion or other intervention toachieve Hgb ≥ 10.0 g/dl is acceptable); Creatinine clearance ≥ 50 mg/dl; Bilirubin < 1.5 mg/dl; WBC ≥ 3,000/μl; ALT/AST < 3 x ULN; INR ≤ 1.5
Negative serum pregnancy test for women of child-bearing potential
Exclusion
Exclusion Criteria:
Prior invasive malignancy (except non-melanomatous skin cancer), unless disease freefor a minimum of 3 years;
Prior systemic chemotherapy within the past three years
Prior radiotherapy to the pelvis or abdomen that would result in overlap ofradiation therapy fields;
Para-aortic, inguinal, or gross (unresected) pelvic nodal metastasis. Gross pelvicnodal metastasis is defined as either: Radiographic evidence of nodal metastasis onCT or MRI (node having short axis diameter > 1 cm)OR Radiographic evidence of nodalmetastasis on diagnostic FDG-PET or PET/CT scan (abnormally increased FDG uptake asdetermined and documented by the radiologist)OR Biopsy-proven metastasis (e.g.needle biopsy) in undissected node
Distant metastasis
Unstable angina and/or congestive heart failure requiring hospitalization within thepast 6 months
Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
Uncontrolled diabetes, defined as diabetes mellitus, which in the opinion of any ofthe patient's physicians requires an immediate change in management;
Uncompensated heart disease or uncontrolled high blood pressure
Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC definition
Study Design
Study Description
Connect with a study center
Xijing Hospital
Xi'an, 710032
ChinaSite Not Available
University Hospital Hradec Králové
Hradec Králové,
Czech RepublicSite Not Available
University Hospital Hradec Králové
Hradec Králové,
CzechiaSite Not Available
Tata Memorial Hospital
Parel, Mumbai 400 012
IndiaSite Not Available
Asan (Hyundai) Medical Center
Songpa-Gu, Seoul
Korea, Republic ofSite Not Available
Marie Sklodowska Cancer Center
Gliwice,
PolandSite Not Available
Far Eastern Memorial Hospital
Pan-Chiao, Taipai 220
TaiwanSite Not Available
King Chulalongkorn Hospital
Bangkok,
ThailandSite Not Available
Istanbul Bilim University
Gayrettepe, Istabul 34340
TurkeySite Not Available
Royal Surrey County Hospital
Guildford, Surrey 7XX
United KingdomSite Not Available
Moores UC San Diego Cancer Center
La Jolla, California 92093
United StatesSite Not Available
University of Miami Miller School of Medicine
Miami, Florida 33136
United StatesSite Not Available
Moffitt Cancer Center and Research Institute, H. Lee Moffitt Cancer Center
Tampa, Florida 33612
United StatesSite Not Available
Holden Comprehensive Cancer Center
Iowa City, Iowa 52242
United StatesSite Not Available
University of Pittsburgh Cancer Center, UPMC
Pittsburgh, Pennsylvania 15243
United StatesSite Not Available
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