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Tomotherapy in Postsurgery Recurrent Carcinoma Cervix
Conditions
Postsurgery Recurrent Carcinoma Cervix
Conditions: official terms
Carcinoma - Uterine Cervical Neoplasms
Conditions: Keywords
recurrent carcinoma cervix, Vault carcinoma, Tomotherapy, Brachytherapy
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Radiotherapy
Type: Radiation
Overall Status
Recruiting
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
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
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 65 Years
Minimum Age: 18 Years
Gender: Female
Criteria: 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.
. 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.
Location
Tata Memorial Centre
Mumbai, Maharashtra, India
Status: Recruiting
Contact: Reena Engineer, MD - +912224177165 - reena_engineer@rediffmail.com
Start Date
December 2008
Completion Date
December 2014
Sponsors
Tata Memorial Hospital
Source
Tata Memorial Hospital
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
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