Tomotherapy in Postsurgery Recurrent Carcinoma Cervix

NCT01117402 | Unknown Phase 2 DMC

• 1 other identifier: IRB 588
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Postsurgery Recurrent Carcinoma Cervix

Keywords

recurrent carcinoma cervix; Vault carcinoma; Tomotherapy; Brachytherapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• To study the late toxicities associated with this treatment

  3 Years

Interventions

Radiotherapy RADIATION

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.

Also known as: IMRT, Template brachytherapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tata Memorial Hospital: lead

Study Sites (1)

Tata Memorial Centre

Mumbai, Maharashtra, 400012, India

RECRUITING

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Reena Engineer, MD

  Tata Memorial Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Reena Engineer, MD

CONTACT

+912224177165

ShyamKishore Shrivastava, MD

CONTACT

+912224177163; shrivastavask@tmc.gov.in

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: May 4, 2010
• First Posted: May 5, 2010
• Study Start: December 1, 2008
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2014
• Last Updated: May 5, 2010

Record last verified: 2010-05

Locations

IN (1)