Clinical trial NCT01117402: Tomotherapy in Postsurgery Recurrent Carcinoma Cervix
Official title: Phase II Study Evaluating the Role of Tomotherapy- Based Intensity Modulated Radiotherapy and Brachytherapy in Postsurgery Recurrent Carcinoma Cervix
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Postsurgery Recurrent Carcinoma Cervix
Keywords: recurrent carcinoma cervix
Vault carcinoma
Tomotherapy
Brachytherapy
Lead sponsor: Tata Memorial Hospital
Sponsor class: OTHER_GOV
First posted: 2010-05-05
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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

Eligibility 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.

Primary outcomes:
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
timeFrame: 3 Years
Secondary outcomes:
measure: To study the late toxicities associated with this treatment
timeFrame: 3 Years
Other outcomes:
Locations:
city: Mumbai
country: India
facility: Tata Memorial Centre
state: Maharashtra
Study officials:
affiliation: Tata Memorial Centre
name: Reena Engineer, MD
role: PRINCIPAL_INVESTIGATOR
References: