To evaluate the impact of PET scan based radiotherapy planning for cervical cancer in Indian women.
- Conditions
- Health Condition 1: null- Carcinoma cervix
- Registration Number
- CTRI/2016/05/006924
- Lead Sponsor
- Department of Biotechnology Government of India
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 60
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 <= 1.0 mg/dL and calculated creatinine clearance >= 50 cc/min. Both tests must be within these limits.
The creatinine clearance should be calculated using the Cockcroft-Gault formula: (See Section)
AST <= 2 x ULN
Bilirubin <= 2 x ULN
Alkaline phosphatase, Mg, BUN and electrolytes must be obtained and recorded
Patients must provide study specific informed consent prior to study entry.
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Determine the rates of grade 3 acute gastrointestinal and genitourinary toxicity according to NCI CTCAE v4. <br/ ><br>2. Tumor control <br/ ><br>Timepoint: 3 weeks into treatment <br/ ><br>End of external radiotherapy <br/ ><br>6 weeks post treatment <br/ ><br>3 months post treatment <br/ ><br> <br/ ><br>For tumor control: 3 months post treatment and every followup thereafter. <br/ ><br> <br/ ><br>
- Secondary Outcome Measures
Name Time Method To determine the local control at 3 years for patients undergoing PETCT based definitive IMRT. <br/ ><br>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 <br/ ><br>To determine the incidence of late GI and GU toxicity in patients treated with this regimen. <br/ ><br>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 <br/ ><br>Timepoint: 3 years