Phase II Study Evaluating the Role of Tomotherapy- Based Intensity Modulated Radiotherapy and Brachytherapy in Postsurgery Recurrent Carcinoma Cervix
18 Years
65 Years
Female
Postsurgery Recurrent Carcinoma Cervix
Trial Information
Phase II Study Evaluating the Role of Tomotherapy- Based Intensity Modulated Radiotherapy and Brachytherapy in Postsurgery Recurrent Carcinoma Cervix
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
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.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
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
Outcome Description:
Progression free survival of all patients
Outcome Time Frame:
3 Years
Safety Issue:
Yes
Principal Investigator
Reena Engineer, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Tata Memorial Centre
Authority:
India: Institutional Review Board
Study ID:
IRB 588
NCT ID:
NCT01117402
Start Date:
December 2008
Completion Date:
December 2014
Related Keywords:
- Postsurgery Recurrent Carcinoma Cervix
- recurrent carcinoma cervix
- Vault carcinoma
- Tomotherapy
- Brachytherapy
- Carcinoma
- Uterine Cervical Neoplasms
Name | Location |
|---|
