Status:
COMPLETED
Intensity-Modulated Radiation Therapy to the Pelvis With or Without Chemotherapy in Treating Patients With Endometrial Cancer or Cervical Cancer That Has Been Removed By Surgery
Lead Sponsor:
Radiation Therapy Oncology Group
Collaborating Sponsors:
National Cancer Institute (NCI)
NRG Oncology
Conditions:
Cervical Cancer
Endometrial Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
RATIONALE: Specialized radiation therapy (RT), such as intensity-modulated radiation therapy (IMRT), that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause le...
Detailed Description
OBJECTIVES: * Determine the transportability of intensity modulated radiotherapy (IMRT) to a multi-institutional setting in patients with resected endometrial or cervical cancer. * Compare the effica...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Must have undergone a hysterectomy (total abdominal, vaginal, radical, or laparoscopic-assisted vaginal) within 7 weeks prior to study entry
- Patients with endometrial cancer must have also undergone a bilateral salpingo-oophorectomy
- Histologically confirmed diagnosis of 1 of the following:
- Endometrial cancer meeting 1 of the following criteria:
- Stage IB grade 3, IC grade 1-3, IIA, or IIB disease requiring postoperative pelvic radiotherapy
- Unstaged (no lymph node dissection or sampling) stage IB grade 2 disease
- Stage IIIC with all of the following:
- Pelvic lymph node positive only
- Para-aortic nodes sampled negative
- Not receiving chemotherapy
- Cervical cancer meeting 1 of the following criteria:
- Post-radical hysterectomy and requires postoperative pelvic radiotherapy due to any of the following:
- Positive pelvic nodes (negative para-aortic nodes)
- Microscopic parametrial involvement and negative margins
- Disease qualified by Sedlis criteria must have 2 of the following risk factors:
- 1/3 or more stromal invasion
- Lymph-vascular space invasion
- Large clinical tumor diameter (≥ 4 cm)
- Post-simple hysterectomy with negative margins and negative nodes by CT scan, MRI, or positron emission tomography-CT scan
- No requirement for extended-field radiotherapy beyond the pelvis
- No histologically confirmed papillary serous, clear cell, or neuroendocrine (either large or small cell) disease, endometrial stromal sarcoma, leiomyosarcoma, or malignant müllerian mixed tumor
- No evidence of metastatic disease outside of the pelvis
- No microscopic involvement of the resection margin (\< 3 mm)
- PATIENT CHARACTERISTICS:
- Zubrod performance status 0-2
- WBC (white blood cell count) ≥ 4,000/mm³ (cervical cancer patients only)
- Absolute neutrophil count ≥ 1,800/mm³ (cervical cancer patients only)
- Platelet count ≥ 100,000/mm³ (cervical cancer patients only)
- Hemoglobin ≥ 8.0 g/dL (transfusion allowed)
- Serum creatinine ≤ 2.0 mg/dL (cervical cancer patients only)
- Creatinine clearance ≥ 50 mL/min (cervical cancer patients only)
- AST (aspartate aminotransferase) ≤ 2 times upper limit of normal
- Bilirubin ≤ 2 times upper limit of normal
- Patients must not exceed the weight and size limits of the treatment table or CT scanner
- No mental status changes or bladder control problems that would preclude study compliance with bladder-filling instructions
- No active inflammatory bowel disease
- No severe, active, concurrent illness, defined as any of the following:
- Unstable angina and/or congestive heart failure requiring hospitalization within the past 6 months
- Transmural myocardial infarction within the past 6 months
- Acute bacterial or fungal infection requiring IV antibiotics
- Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy
- Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
- AIDS
- No history of allergy to cisplatin (cervical cancer patients)
- No prior invasive malignancy (except nonmelanoma skin cancer) unless disease-free for ≥ 3 years
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior radiotherapy to the pelvis that would result in overlap of radiotherapy fields
- No prior platinum-based chemotherapy (cervical cancer patients)
- No concurrent prophylactic growth factors (e.g., filgrastim \[G-CSF\], sargramostim \[GM-CSF\], or pegfilgrastim)
- No concurrent prophylactic thrombopoietic agents
- No concurrent amifostine or other protective agents
Exclusion
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2016
Estimated Enrollment :
106 Patients enrolled
Trial Details
Trial ID
NCT00331760
Start Date
March 1 2006
End Date
December 1 2016
Last Update
February 26 2019
Active Locations (153)
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1
Auburn Radiation Oncology
Auburn, California, United States, 95603
2
Radiation Oncology Centers - Cameron Park
Cameron Park, California, United States, 95682
3
Mercy Cancer Center at Mercy San Juan Medical Center
Carmichael, California, United States, 95608
4
East Bay Radiation Oncology Center
Castro Valley, California, United States, 94546