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| 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) |
| STRATIFY | REGISTER |
| Diagnosis | |
- Endometrial Carcinoma
- Cervical Carcinoma
|
- Endometrial cancer patients: IMRT 28 fractions over 5.5 weeks
- 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 |
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