Tomotherapy in Postsurgery Recurrent Carcinoma Cervix

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2010 by Tata Memorial Hospital
Sponsor:
Information provided by:
Tata Memorial Hospital
ClinicalTrials.gov Identifier:
NCT01117402
First received: May 4, 2010
Last updated: NA
Last verified: May 2010
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Postsurgery Recurrent Carcinoma Cervix
Radiation: Radiotherapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study Evaluating the Role of Tomotherapy- Based Intensity Modulated Radiotherapy and Brachytherapy in Postsurgery Recurrent Carcinoma Cervix

Further study details as provided by Tata Memorial Hospital:

Primary Outcome Measures:
  • 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 [ Time Frame: 3 Years ] [ Designated as safety issue: Yes ]
    Progression free survival of all patients


Secondary Outcome Measures:
  • To study the late toxicities associated with this treatment [ Time Frame: 3 Years ] [ Designated as safety issue: Yes ]
    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


Estimated Enrollment: 90
Study Start Date: December 2008
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    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.

    Other Names:
    • IMRT
    • Template brachytherapy
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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01117402

Contacts
Contact: Reena Engineer, MD +912224177165
Contact: ShyamKishore Shrivastava, MD +912224177163 shrivastavask@tmc.gov.in

Locations
India
Tata Memorial Centre Recruiting
Mumbai, Maharashtra, India, 400012
Contact: Reena Engineer, MD    +912224177165    reena_engineer@rediffmail.com   
Contact: ShyamKishore Shrivastava, MD    +912224177163    shrivastavask@tmc.gov.in   
Principal Investigator: Reena Engineer, MD         
Sponsors and Collaborators
Tata Memorial Hospital
Investigators
Principal Investigator: Reena Engineer, MD Tata Memorial Centre
  More Information

No publications provided

Responsible Party: Dr Reena Engineer, Tata Memorial Centre
ClinicalTrials.gov Identifier: NCT01117402     History of Changes
Other Study ID Numbers: IRB 588
Study First Received: May 4, 2010
Last Updated: May 4, 2010
Health Authority: India: Institutional Review Board

Keywords provided by Tata Memorial Hospital:
recurrent carcinoma cervix
Vault carcinoma
Tomotherapy
Brachytherapy

Additional relevant MeSH terms:
Uterine Cervical Diseases
Carcinoma
Uterine Cervical Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on September 22, 2014