A Trial Comparing Intensity Modulated Radiation Therapy (IMRT) With Conventional Radiation Therapy in Stage IIB Carcinoma Cervix

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2008 by Tata Memorial Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Varian Medical Systems
Information provided by:
Tata Memorial Hospital
ClinicalTrials.gov Identifier:
NCT00193804
First received: September 13, 2005
Last updated: July 19, 2011
Last verified: July 2008
  Purpose

A study to evaluate the efficacy of Intensity Modulated Radiation Therapy (IMRT) as compared to Standard Conventional Radiotherapy Alone in the treatment of carcinoma cervix. Concomitant Weekly Cisplatin chemotherapy will be given as a routine, which is a standard of care today for early stage cervical cancers including stage IIB. The benefits of using IMRT in reducing radiation-induced toxicity are well known. Since this treatment modality has not yet been validated and studied in a randomized trial setting, the present study is being undertaken. The study arm of IMRT has the potential to reduce the toxicities by 15-20%, but is associated with labor intense procedure requiring many hospital visits before actual start of treatment.


Condition Intervention Phase
Cancer of Cervix
Radiation: IMRT
Phase 2

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Phase II Randomized Trial Comparing Intensity Modulated Radiation Therapy (IMRT) With Conventional Radiation Therapy in Stage IIB Carcinoma Cervix

Resource links provided by NLM:


Further study details as provided by Tata Memorial Hospital:

Primary Outcome Measures:
  • To compare the normal tissue toxicities (Acute & Late) of standard radiation therapy with IMRT [ Time Frame: 2010 ] [ Designated as safety issue: No ]
  • To evaluate the IMRT in Stage IIB carcinoma cervix [ Time Frame: 2010 ] [ Designated as safety issue: No ]
  • To compare the disease free survivals [ Time Frame: 2010 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To compare the overall survivals [ Time Frame: 2010 ] [ Designated as safety issue: No ]
  • To compare the quality of life in both the groups [ Time Frame: 2010 ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: February 2005
Estimated Study Completion Date: February 2012
Groups/Cohorts Assigned Interventions
2
Patients with histologically proven, cervical cancer FIGO Stage IIB eligible will be invited for the study
Radiation: IMRT
IMRT in cervical cancers

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients with histologically proven cervical cancers, FIGO Stage IIb eligible for the study will be invited for the study

Criteria

Inclusion Criteria:

  • Histologically proven squamous carcinoma or adenocarcinoma of cervix
  • Performance index WHO grade 0 or 1
  • Patients below 65 years of age
  • FIGO Stage IIB
  • Normal ECG and Cardiovascular system
  • Normal hematological parameters
  • Normal renal and liver function tests

Exclusion Criteria:

  • Co-morbid conditions like medical renal disease
  • Medical or Psychological condition that would preclude treatment
  • H/o Previous treatment / Pregnancy
  • Patient unreliable for treatment completion 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: NCT00193804

Contacts
Contact: Shyamkishore J Shrivastava, MD, DNB(RT) +91-22-2417 7163 sshyam@mtnl.net.in
Contact: Umesh M Mahantshetty, MD, DNB (RT) +91-22-2417 7168 drumeshm@yahoo.com

Locations
India
Tata Memorial Hospital Recruiting
Mumbai, Maharastra, India, 400 012
Contact: Shyamkishore J Shrivastava, MD, DNB (RT)    +91-22-2417 7163    sshyam@mtnl.net.in   
Contact: Umesh M Mahantshetty, MD, DNB (RT)    +91-22-2417 7168    drumeshm@yahoo.com   
Principal Investigator: Shyamkishore J Shrivastava, MD, DNB (RT)         
Sponsors and Collaborators
Tata Memorial Hospital
Varian Medical Systems
Investigators
Principal Investigator: Shyamkishore J Shrivastava, MD, DNB (RT) Professor & Head, Radiation Oncology, Tata Memorial Hospital
  More Information

No publications provided

Responsible Party: Dr SK Shrivastava, Tata Memorial Hospital
ClinicalTrials.gov Identifier: NCT00193804     History of Changes
Other Study ID Numbers: TMH/158/2004/Cx_IMRT TRIAL
Study First Received: September 13, 2005
Last Updated: July 19, 2011
Health Authority: India: Department of Atomic Energy

Keywords provided by Tata Memorial Hospital:
Cervical Cancer
FIGO STAGE IIB
CHEMORADIATION
Intensity Modulated Radiation Therapy(IMRT)
Conventional Radiation Therapy
Cancer of the Cervix
Cervix Cancer

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on October 01, 2014