Tomotherapy in Postsurgery Recurrent Carcinoma Cervix

Phase II Study Evaluating the Role of Tomotherapy- Based Intensity Modulated Radiotherapy and Brachytherapy in Postsurgery Recurrent Carcinoma Cervix

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.

Study Overview

• Status: Unknown
• Conditions: Postsurgery Recurrent Carcinoma Cervix
• Intervention / Treatment: Radiation: Radiotherapy

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

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Phase 2

Contacts and Locations

Study Locations

• India
  • Maharashtra
    • Mumbai, Maharashtra, India, 400012
      • Recruiting
      • Tata Memorial Centre
      • Contact: Reena Engineer, MD; Phone Number: +912224177165; Email: reena_engineer@rediffmail.com
      • Contact: ShyamKishore Shrivastava, MD; Phone Number: +912224177163; Email: shrivastavask@tmc.gov.in
      • Principal Investigator: Reena Engineer, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Progression free survival of all patients	3 Years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To study the late toxicities associated with this treatment	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	3 Years

Collaborators and Investigators

• Sponsor: Tata Memorial Hospital
• Investigators: Principal Investigator: Reena Engineer, MD, Tata Memorial Centre

Study record dates

Study Major Dates

• Study Start: December 1, 2008
• Primary Completion (Anticipated): December 1, 2013
• Study Completion (Anticipated): December 1, 2014

Study Registration Dates

• First Submitted: May 4, 2010
• First Submitted That Met QC Criteria: May 4, 2010
• First Posted (Estimate): May 5, 2010

Study Record Updates

• Last Update Posted (Estimate): May 5, 2010
• Last Update Submitted That Met QC Criteria: May 4, 2010
• Last Verified: May 1, 2010

More Information

Terms related to this study

• Keywords: Brachytherapy; Tomotherapy; recurrent carcinoma cervix; Vault carcinoma
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Disease Attributes; Carcinoma; Recurrence
• Other Study ID Numbers: IRB 588