CTRI/2016/05/006924
Recruiting
Phase 2
Phase II study to evaluate toxicity and clinical outcomes of definitive Helical Tomotherapy for primarily unresected carcinoma cervix using Fluoro-deoxy glucose Positron Emission Tomography based radiotherapy planning [PET Study]â??
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Health Condition 1: null- Carcinoma cervix
- Sponsor
- Department of Biotechnology Government of India
- Enrollment
- 60
- Status
- Recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
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
Outcomes
Primary Outcomes
Not specified
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