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Radiotherapy is the most appropriate treatment for postoperative recurrent carcinoma cervix. However it is technically difficult to deliver adequate doses of RT due to presence of small intestines in the radiation area; thus disease control rates are poor and complication rates are high with conventional radiotherapy. Use of IMRT and brachytherapy for these cases allows for increasing dose to the tumor while sparing normal structures. It is expected that the use of a combination of IMRT & brachytherapy will achieve higher disease control rates and decrease the complication rates.
1. To evaluate the efficacy of combination of intensity-modulated radiotherapy (IMRT) and brachytherapy in delivering dose escalated radiotherapy in postoperative residual / recurrent cases of carcinoma cervix, in terms of local control proportion and progression free survival (PFS)
2. To study the late and acute toxicities associated with this treatment.
3. Dosimetric comparison of Tomotherapy and conventional IMRT
DESIGN: Prospective, phase II study.
STUDY POPULATION: All patients of age < 65 years diagnosed with postsurgery recurrent squamous cell carcinoma cervix without previous history of radiotherapy.
STUDY SIZE: 90 patients
METHODOLOGY: Ninety cases of cervical cancer with postsurgery recurrence limited to the pelvis will be screened and taken for study if eligible after taking the informed consent.
Patients will receive external radiation therapy using IMRT to pelvis with additional dose of localized radiotherapy boost with brachytherapy to the vault with weekly concurrent chemotherapy.
The local recurrence rate and 5 year disease free survival rate of all the patients will be studied.
Total project period : 5 years Recruitment, Data collection : 4 years Complete analysis of data : 1 year
STUDY SITE: Tata memorial centre
Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Postsurgery Recurrent Carcinoma Cervix
Tata Memorial Centre
Tata Memorial Hospital
Published on BioPortfolio: 2014-08-27T03:13:54-0400
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