RTOG Address
Search  
HomeMember InfoProtocolsResearcherMeetingsVisitorsFAQSite Map




Summaries - Gynecology
Gynecology Cancer Protocols
RTOG 0724
Title: Phase III Randomized Study of Concurrent Chemotherapy and Pelvic Radiation Therapy With or Without Adjuvant Chemotherapy in High-Risk Patients With Early-Stage Cervical Carcinoma Following Radical Hysterectomy
Eligibility: Patients must have undergone radical hysterectomy (open, laparoscopically or robotic) and staging including both para-aortic and pelvic node sampling for cervical carcinoma within 70 days prior to study entry.
Patients must have undergone radical hysterectomy (open, laparoscopically or robotic) and staging including both para-aortic and pelvic node sampling for cervical carcinoma within 70 days prior to study entry.
Patients with clinical stage IA2, IB or IIA squamous, adenosquamous, or adenocarcinoma of the cervix who have any/all of the following high-risk features after surgery:
  • positive pelvic nodes; positive parametrium;
  • positive para-aortic nodes- completely resected, PET/CT negative (PET only required if positive para-aortic nodes during surgery).
No distant metastases, based upon the following minimum diagnostic workup:
  • history/physical examination within 56 days prior to study entry;
  • contrast-enhanced imaging of the abdomen and pelvis by either CT, MRI, or PET-CT (whole body) within 90 days prior to registration;
  • chest x-ray (PA and lateral) or chest CT within 70 days prior to study entry (except for those who have had whole body PET-CT).
Zubrod performance status 0-1.
Age > 18.
CBC/differential obtained 14 days prior to study entry, with adequate bone marrow function defined as follows:
  • absolute neutrophil count (ANC) > 1,800 cells/mm3;
  • platelets > 100,000 cells/mm3;
  • hemoglobin > 10.0 g/dl;
  • white blood cell count > 4000 cells/mm3.
Adequate hepatic and renal function defined as follows:
  • serum creatinine 1.5 mg/dL within 14 days prior to study entry;
  • bilirubin 1.5 times normal 14 days prior to study entry;
  • alkaline phosphatase within upper limits of institutional normal within 14 days prior to study entry;
  • AST/SGOT within upper limits of institutional normal within 14 days prior to study entry;
  • patients with known HIV positive must have a CD4 cell count be > 350 cells/mm3 within 14 days prior to study entry (note, however, that HIV testing is not required for entry into this protocol).
Patient must provide study-specific informed consent prior to study entry.
Cisplatin, radiotherapy ±, carboplatin/paclitaxel: Arm A
Concurrent weekly cisplatin and RT ± brachytherapy

Versus

Arm B
Concurrent weekly cisplatin and RT ± brachytherapy

FOLLOWED BY

Carboplatin and paclitaxel
Study size:400


RTOG 0921
Title: A PHASE II STUDY OF POSTOPERATIVE INTENSITY MODULATED RADIATION THERAPY (IMRT) WITH CONCURRENT CISPLATIN AND BEVACIZUMAB FOLLOWED BY CARBOPLATIN AND PACLITAXEL FOR PATIENTS WITH ENDOMETRIAL CANCER
Eligibility: Patients must have undergone a hysterectomy (total abdominal, vaginal, robotic-assisted, radical, or laparoscopic-assisted vaginal hysterectomy) for carcinoma of the uterus within 56 days prior to study entry. Patients must also have had a bilateral salpingo-oophorectomy. Patients must have confirmed uterine cancer with one of the following: Grade 3 carcinoma with greater than 50% myometrial invasion (Stages IC or IIA); all papillary serous and clear cell carcinoma will be considered Grade 3. Grade 2 or 3 carcinoma with any cervical stromal invasion (Stage IIB); Known extra-uterine disease confined to the pelvis (Stages III-IVA), any grade; Endometrioid endometrial adenocarcinoma, clear-cell carcinoma, papillary serous adenocarcinoma, adenosquamous carcinoma, or other adenocarcinoma variant histologies; Patients must have Zubrod performance status 0-1; Age > 18; History/physical examination including normal post-operative exam within 56 days prior to study entry; Patients must have adequate bone marrow, renal and hepatic function; as indicated by the following laboratory assessments within 21 days prior to study entry: ANC > to 1500cells/mm³; without use of growth factors, Platelets > 100,000/mm3; Serum creatinine < 1.5 mg/dl; Total bilirubin < 1.5 times institutional upper normal limit; Hemoglobin > 10 g/dl; (transfusion may be used to meet this criterion); AST and ALT < 2 times institutional upper normal limit; Urine protein should be screened by urine analysis for Urine Protein Creatinine (UPC) ratio. For UPC ratio > 0.5, 24-hour urine protein should be obtained and should be <1000 mg for patient enrollment. Note: UPC ratio of spot urine is an estimation of the 24-hour urine protein excretion - a UPC ratio of 1 is roughly equivalent to a 24-hour urine protein of 1 gm. The UPC ratio is calculated using one of the following formulae: [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; INR < 1.5 for patients treated with Warfarin within 14 days prior to study entry; To assess the abdomen and pelvis in patients with FIGO stage III or IVA disease, CT or PET-CT of the abdomen and pelvis within 56 days of study entry; To assess the chest for all patients regardless of stage, a chest x-ray or chest CT or PET-CT within 56 days of study entry; Patients must sign a study-specific informed consent.

Concurrent Chemoradiation

Adjuvant Chemotherapy		 PELVIC IMRT WITH OPTIONAL BOOST AND CONCURRENT CISPLATIN AND BEVACIZUMAB

FOLLOWED WITH ADJUVANT CHEMOTHERAPY OF CARBOPLATIN AND PACLITAXEL
Study size:34