Phase II Study Evaluating the Role of Tomotherapy- Based Intensity Modulated Radiotherapy and Brachytherapy in Postsurgery Recurrent Carcinoma Cervix
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
The local recurrence rate and 5 year disease free survival rate of all the patients will be
Total project period : 5 years Recruitment, Data collection : 4 years
Complete analysis of data : 1 year
STUDY SITE: Tata memorial centre
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To evaluate the utility of intensity-modulated radiotherapy (IMRT) in delivering dose escalated radiotherapy in postoperative recurrent cases of carcinoma cervix, in terms of local control
Progression free survival of all patients
Reena Engineer, MD
Tata Memorial Centre
India: Institutional Review Board