Health Condition 1: null- Carcinoma cervix
Conditions
Interventions
Intervention1: PET CT based radiation therapy planning and prospective documentation of tumor response and morbidity: Radiotherapy planning is a multistep process that starts with a treatment decision
Sponsors
Department of Biotechnology Government of India
Eligibility
Inclusion criteria
Inclusion criteria: 3.1 Conditions for patient eligibility 3.1.1 Pathologically proven diagnosis of cervical cancer within 90 days of registration 3.1.2 Appropriate stage for protocol entry, including no ineligible node criteria or distant metastases, based upon the following minimum diagnostic workup: History/physical examination within 45 days prior to registration Patient is between 18 â?? 65 years Chest X Ray, MRI pelvis and whole body PET-CT should be performed for initial radiological staging. ECOG Performance Status 0-2 CBC/differential obtained within 14 days prior to registration on study, with adequate bone marrow function defined as follows: Absolute neutrophil count (ANC) >= 1,500 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.) For patients receiving chemotherapy: Cisplatin will be used concurrent with radiation therapy to a dose of 40 mg/m2 to a maximum dose of 70 mg weekly for 5 such cycles. Within 14 days prior to registration, serum creatinine = 50 cc/min. Both tests must be within these limits. The creatinine clearance should be calculated using the Cockcroft-Gault formula: (See Section) AST Bilirubin Alkaline phosphatase, Mg, BUN and electrolytes must be obtained and recorded Patients must provide study specific informed consent prior to study entry.
Exclusion criteria
Exclusion criteria: Patients who exceed the weight/size limit of the treatment table or CT scanner, mental status Changes or bladder control problems that make the patient unable to comply with bladder-filling instructions, patients with distant metastases, nodes within 2 cm of the midline in the span of the uterus and /or para aortic lymph node disease above the level of aortic bifurcation, nodes > 3 cm Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months Transmural myocardial infarction within the last 6 months Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration Other major medical illness which requires hospitalization Hepatic insufficiency Patients with prior treatment with platinum-based chemotherapy Poorly controlled diabetes
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Determine the rates of grade 3 acute gastrointestinal and genitourinary toxicity according to NCI CTCAE v4. 2. Tumor control Timepoint: 3 weeks into treatment End of external radiotherapy 6 weeks post treatment 3 months post treatment For tumor control: 3 months post treatment and every followup thereafter. | — |
Secondary
| Measure | Time frame |
|---|---|
| To determine the local control at 3 years for patients undergoing PETCT based definitive IMRT. A capacity to detect a pelvic failure rate of 40 to 50% given that more than 90% of the patients will be locally advanced carcinoma cervix To determine the incidence of late GI and GU toxicity in patients treated with this regimen. To evaluate the quality of life using the Cervix specific questionnaires and measure the impact of this regimen of radiotherapy on the QoL of patients Timepoint: 3 years | — |
Countries
India
Contacts
Public ContactDr Rimpa Basu Achari
Tata Medical Center
Outcome results
None listed