Tomotherapy in Postsurgery Recurrent Carcinoma Cervix

Postsurgery Recurrent Carcinoma Cervix Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01117402
• Other study ID #: IRB 588
• Status: Recruiting
• Phase: Phase 2
• First received: May 4, 2010
• Last updated: May 4, 2010
• Start date: December 2008
• Est. completion date: December 2014

Study information

• Verified date: May 2010
• Source: Tata Memorial Hospital
• Contact: Reena Engineer, MD
• Phone: +912224177165
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

. Only histologically proven postoperative recurrence of squamous carcinoma of cervix following hysterectomy >3 months without adjuvant treatment

• Patients below 65 years of age and with KPS >70%.

• Patients with disease confined to the pelvis, based on CT/MRI/PET Scan

• Normal ECG and cardiovascular system

• Normal hematological parameters

• Normal renal and liver function tests

Exclusion Criteria:

• Previous chemotherapy or radiotherapy to the pelvis

• Pelvic LN >3cm in size

• Presence of disease outside the pelvis (Paraortic nodes, distant metastasis)

• Bilateral hydronephrosis

• Co-morbid conditions like uncontrolled Diabetes Mellitus or medical renal disease

• Medical or Psychological condition that would preclude treatment

• Patient unreliable for treatment and follow-up.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Postsurgery Recurrent Carcinoma Cervix
• Uterine Cervical Neoplasms

Intervention

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.

Locations

Country	Name	City	State
India	Tata Memorial Centre	Mumbai	Maharashtra

Sponsors (1)

Lead Sponsor	Collaborator
Tata Memorial Hospital

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	3 Years	Yes
Secondary	To study the late toxicities associated with this treatment	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	3 Years	Yes