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Summaries - Gynecology
Gynecology Cancer Protocols

RTOG 0417
Title: A Phase II Study of Bevacizumab in Combination With Definitive Radiotherapy and Cisplatin Chemotherapy in Untreated Patients With Locally Advanced Cervical Carcinoma
Eligibility:

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 > or = 5 cm. All patients must have confirmation of diagnosis by cervical biopsy within 8 weeks prior to study entry. Biopsies must be done > 7 days prior to study entry. Zubrod Performance Status 0-2. Laboratory values must be as follows (Within 21 Days of registration):

White blood cell count: > or = 3,000/mm3
Absolute granulocyte count: > or = 1,500/mm3
Platelets: > or = 100,000/mm3
Total bilirubin: < or = 1.5 mg/dl
Serum creatinine: < or = 1.5 mg/dl
AST and ALT: < or = 2.5 x institutional upper normal limit
Serum calcium: < or = 1.3 x institutional upper normal limit
INR: < 1.5
Serum Pregnancy: Negative
Hemoglobin > or = 10 – Transfusion may be used to meet this criterion

Urine protein screening must be performed within 21 days of study entry. 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. UPC is calculated using one of the following formulas:

  • [urine protein]/[urine creatinine] – if both protein and creatinine are reported in mg/dL
  • [(urine protein) x0.088]/[urine creatinine] – if urine creatinine is reported in mmol/L

Chest X-Ray, Chest CT, or PET-CT within six weeks prior to study entry. 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 6 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. 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 6 weeks prior to study entry. MRI of the pelvis is strongly preferred in order to allow tumor measurement in three dimensions. Signed study-specific informed consent prior to study entry.

Treatment: Pelvic RT: 45 Gy given in 25 once-daily fractions (1.8 Gy/fraction) Monday-Friday over 5 weeks, then LDR x 2 or HDR x 5, then parametrial boost (if indicated)

Bevacizumab (Avastin®): IV Q2 weeks (Days 1, 15 and 29) during chemoradiation, given before cisplatin, on the same day as cisplatin

Cisplatin: Weekly infusion x 6 weeks


Proton pump inhibitor (PPI) medications must be administered to all patients.
Study size: 57


RTOG 0418
Title: A Phase II Study of Intensity Modulated Radiation Therapy (IMRT) to the Pelvis +/- Chemotherapy for Post-operative Patients with either Endometrial or Cervical Carcinoma
Eligibility: Patients must have undergone a hysterectomy (total abdominal hysterectomy, vaginal hysterectomy or radical hysterectomy or laparoscopic-assisted vaginal hysterectomy) for carcinoma of the cervix or endometrium within 7 weeks prior to study entry. Patients with endometrial carcinoma must also have had a bilateral salpingo-oophorectomy. Patients must require postoperative radiation therapy (endometrial cancer) or chemo/radiation therapy (cervical cancer). Endometrial Cancer patients with stage IB, grade 3, IC grade 1-3, IIA or IIB requiring post-operative pelvic radiation therapy are eligible for this trial. Patients with unstaged (no lymph node dissection or sampling) Stage IB, grade 2 are eligible for this trial. Patients with Stage IIIC, pelvic lymph node positive only, para-aortic nodes sampled and negative and not going to receive chemotherapy are eligible for this trial. Cervical Cancer patients initially treated with a radical hysterectomy and lymph node dissection that require post-operative pelvic radiation therapy are eligible for this trial. Cervical cancer patients treated with a simple hysterectomy with negative margins and negative nodes by CT/MRI/PET-CT are eligible for this trial. Cervical cancer patients: post-radical hysterectomy - if the patient has positive pelvic nodes (negative para-aortic nodes); post-radical hysterectomy - if the patient has microscopic parametrial invasion and negative margins; and post-radical hysterectomy - if the patient qualifies by having met the Sedlis criteria for post-surgery for pelvic radiation therapy are eligible for this study. The patient must have two of the following risk factors for this criterion: 1/3 or more stromal invasion; lymph-vascular space invasion; large clinical tumor diameter (> 4 cm); Age > 18; Zubrod performance status 0-2; Patients with adequate bone marrow, renal and hepatic function (all labs are to be obtained < 14 days prior to registration): Hemoglobin > 8.0 g/dl (Note: The use of transfusion or other interventions to achieve Hg > 8.0 g/dl is acceptable.) (Endometrial and cervix patients); WBC > 4,000/mm3 (Cervix patients only);ANC > 1,800 cells/mm3 (Cervix patients only); Platelets > 100,000 cells/mm3(Cervix patients only); Serum Creatinine < 2.0 mg/dl and calculated creatinine clearance > 50 cc/min (Cervix patients only); AST < 2 x ULN (Cervix patients only); Bilirubin < 2 x ULN (Cervix patients only); Alkaline phosphatase, Mg, BUN and electrolytes must be obtained and recorded (Cervix patients only). Prior to registration CT/MRI/PET-CT of abdomen/pelvis, for initial radiological staging, must be performed pre- or post-surgery (Cervix patients only). Chest x-ray or chest CT must be performed within 8 weeks prior to study entry. The patient must sign a study-specific informed consent.
(Treatment)
STRATIFYREGISTER
Diagnosis 
  1. Endometrial Carcinoma

  2. Cervical Carcinoma
  1. Endometrial cancer patients: IMRT 28 fractions over 5.5 weeks

  2. Cervical cancer patients: IMRT 28 fractions over 5.5 weeks and concurrent cisplatin starting on a Monday or a Tuesday for 5 weeks.
Study size:92