NCT01117402

Tomotherapy in Postsurgery Recurrent Carcinoma Cervix

Phase II Study Evaluating the Role of Tomotherapy- Based Intensity Modulated Radiotherapy and Brachytherapy in Postsurgery Recurrent Carcinoma Cervix

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Tata Memorial Hospital · Other Government
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

SPECIFIC OBJECTIVES: 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. PROJECT PERIOD: Total project period : 5 years Recruitment, Data collection : 4 years Complete analysis of data : 1 year STUDY SITE: Tata memorial centre

Conditions

• Postsurgery Recurrent Carcinoma Cervix

Interventions

Type	Name	Description
RADIATION	Radiotherapy	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.

Timeline

• Start date: 2008-12-01
• Primary completion: 2013-12-01
• Completion: 2014-12-01
• First posted: 2010-05-05
• Last updated: 2010-05-05

Locations

1 site across 1 country: India