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Trial Title:
Tomotherapy in Postsurgery Recurrent Carcinoma Cervix
NCT ID:
NCT01117402
Condition:
Postsurgery Recurrent Carcinoma Cervix
Conditions: Official terms:
Carcinoma
Recurrence
Conditions: Keywords:
recurrent carcinoma cervix
Vault carcinoma
Tomotherapy
Brachytherapy
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Unknown status
Study design:
Allocation:
Non-Randomized
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
Radiotherapy
Description:
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.
Other name:
IMRT
Other name:
Template brachytherapy
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
Criteria for 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.
Gender:
Female
Minimum age:
18 Years
Maximum age:
65 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Tata Memorial Centre
Address:
City:
Mumbai
Zip:
400012
Country:
India
Status:
Recruiting
Contact:
Last name:
Reena Engineer, MD
Phone:
+912224177165
Email:
reena_engineer@rediffmail.com
Contact backup:
Last name:
ShyamKishore Shrivastava, MD
Phone:
+912224177163
Email:
shrivastavask@tmc.gov.in
Investigator:
Last name:
Reena Engineer, MD
Email:
Principal Investigator
Start date:
December 2008
Completion date:
December 2014
Lead sponsor:
Agency:
Tata Memorial Hospital
Agency class:
Other
Source:
Tata Memorial Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01117402
