Tomotherapy in Postsurgery Recurrent Carcinoma Cervix
Recruitment status was Recruiting
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study Evaluating the Role of Tomotherapy- Based Intensity Modulated Radiotherapy and Brachytherapy in Postsurgery Recurrent Carcinoma Cervix|
- 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 [ Time Frame: 3 Years ] [ Designated as safety issue: Yes ]Progression free survival of all patients
- To study the late toxicities associated with this treatment [ Time Frame: 3 Years ] [ Designated as safety issue: Yes ]Side effects of radiotherapy and chemotherapy will be recorded at baseline, during treatment, at 6 and 12 months and annually thereafter according to the RTOG scales
|Study Start Date:||December 2008|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
- Template brachytherapy
Patients will receive external radiation therapy using IMRT to pelvis. Treatment volume (CTV, vault and uninvolved pelvic nodes) will receive a dose of 50-56Gy over 25-28# and gross pelvic nodes will receive 55-62Gy over 25-28 fractions over 5 weeks. Pre RT daily MV CT imaging would be done on Tomotherapy to look and correct for any set up error or anatomic variations.
Chemotherapy will be given weekly - cisplatin 40mg/m2 with prechemo medication. After completion of IMRT all patients will be evaluated for boost to vaginal vault with interstitial template brachytherapy to a dose of 16-20 Gy with HDR in 4-5 fractions. Patients not eligible for brachytherapy will get additional boost to vault and parametrium by EBRT to a dose of 15-20Gy in 6-8 fractions.
- 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)
- To study the late and acute toxicities associated with this treatment.
- 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01117402
|Contact: Reena Engineer, MD||+912224177165|
|Contact: ShyamKishore Shrivastava, MDfirstname.lastname@example.org|
|Tata Memorial Centre||Recruiting|
|Mumbai, Maharashtra, India, 400012|
|Contact: Reena Engineer, MD +912224177165 email@example.com|
|Contact: ShyamKishore Shrivastava, MD +912224177163 firstname.lastname@example.org|
|Principal Investigator: Reena Engineer, MD|
|Principal Investigator:||Reena Engineer, MD||Tata Memorial Centre|