Health Condition 1: null- Biopsy-proven, Stage I-IV invasive cervical carcinoma. Post-hysterectomy with high-risk features or Locally advanced, inoperable/intact cervix
Conditions
Interventions
Intervention1: Intensity Modulated Radiation Therapy (IMRT): IMRT, 45.0 (intact) or 50.4 Gy (Postoperative high-risk) in 1.8 Gy daily fractions over 5-5.5 weeks
Intracavitary Brachytherapy (Optional f
Sponsors
University of California San Diego
Eligibility
Inclusion criteria
Inclusion criteria: 1. Biopsy-proven, invasive squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the cervix 2. Biopsy result positive for carcinoma within 60 days prior to registration 3. FIGO clinical stage I-IVA disease (see Appendix II), based on standard diagnostic workup, including: History/physical examination Examination under anesthesia (if indicated)i. If the patient is status post hysterectomy, one or more of the following conditions must be present: positive lymph nodes, positive margins, parametrial invasion, or non-radical surgery (i.e., simple hysterectomy). ii. If the patient is inoperable, one or more of the following conditions must be present: clinical stage IB2-IVA, positive lymph nodes on nodal sampling or frozen section, and/or parametrial invasion 4. History/physical examination within 14 days prior to registration to document cervical tumor size and stage 5. Within 42 days prior to registration, the patient must have any of the following, if clinically indicated: examination under anesthesia, cystoscopy, sigmoidoscopy, rigid proctoscopy, or colonoscopy. 6. X-ray (PA and lateral), CT scan, or PET/CT scan of the chest within 42 days prior to registration 7. CT scan, MRI, or PET/CT of the pelvis within 42 days prior to registration; 8. Karnofsky Performance Status 60-100 (see Appendix III) 9. Age >= 18 10. Laboratory data obtained 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 to achieve Hgb >= 10.0 g/dl is acceptable) Creatinine clearance >= 50 mg/dl Bilirubin WBC >= 3,000/μl ALT/AST INR Negative serum pregnancy test for women of child-bearing potential 11. Women of childbearing potential must have a negative serum pregnancy test and must agree to practice effective birth control throughout their participation in the treatment phase of the study. 12. If there is clinical suspicion of AIDS, an HIV test must be done within 42 days prior to registration.Note: HIV positive patients with a CD4+ T cell count > 200 per μL of blood and >14% of all lymphocytes are eligible for this trial. 13. Patients must sign informed consent prior to study entry.
Exclusion criteria
Exclusion criteria: 1. Prior invasive malignancy (except non-melanomatous skin cancer), unless disease free for a minimum of 3 years; 2. Prior systemic chemotherapy within the past three years 3. Prior radiotherapy to the pelvis or abdomen that would result in overlap of radiation therapy fields; 4. Para-aortic, inguinal, or gross (unresected) pelvic nodal metastasis. Gross pelvic nodal metastasis is defined as either: Radiographic evidence of nodal metastasis on CT or MRI (node having short axis diameter > 1 cm) Radiographic evidence of nodal metastasis on diagnostic FDG-PET or PET/CT scan (abnormally increased FDG uptake as determined and documented by the radiologist) ï?· Biopsy-proven metastasis (e.g. needle biopsy) in undissected node 5. Distant metastasis 6. Severe, active co-morbidity, defined as follows: iii. Unstable angina and/or congestive heart failure requiring hospitalization within the past 6 months; iv. Transmural myocardial infarction within the last 6 months; v. Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration; vi. Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration; vii. Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; viii. Uncontrolled diabetes, defined as diabetes mellitus, which in the opinion of any of the patientâ??s physicians requires an immediate change in management; a patient may be considered eligible for the study if the physician managing the patientâ??s diabetes considers that the appropriate changes in management have resulted in adequatecontrol. ix. Uncompensated heart disease or uncontrolled high blood pressure, which in the opinion of any of patientâ??s physicians, requires immediate change in management; a patient may be considered eligible for the study if the physician managing the patientâ??s heart disease or blood pressure considers that the appropriate changes in management have resulted in adequate control. x. Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC definition; patients with AIDS will be ineligible for this protocol because the treatments involved may be significantly immunosuppressive. Patients with clinical suspicion of AIDS and who are unwilling to have an HIV test are not eligible for this trial. xi. Uncontrolled infection xii. Other immunocompromised status (e.g., organ transplant or chronic glucocorticoid use). 7. Women who are pregnant or lactating are ineligible due to teratogenic effects on developing fetuses. Women who are of child-bearing potential need to practice effective methods of contraception including oral contraceptives, intrauterine device, diaphragm with spermicides, and/or abstinence. 8. Women participating on substudy 2 or substudy 3 should not have a prior history of hip, pelvic, or lumbosacral prosthesis or other implanted device.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Acute grade 3 more than or equal to neutropenia and clinically significant grade 2 more than or equal to small bowel toxicity (diarrhea)Timepoint: Acute grade 3 more than or equal to neutropenia and clinically significant grade 2 more than or equal to small bowel toxicity (diarrhea) | — |
Secondary
| Measure | Time frame |
|---|---|
| No planned secondary outcomesTimepoint: Not applicable | — |
Countries
China, Czech Republic, Poland, United States of America
Contacts
Public ContactDr Umesh Mahantshetty
Tata Memorial Hospital
Outcome results
None listed