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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00193804
Recruitment Status : Completed
First Posted : September 19, 2005
Last Update Posted : September 16, 2019
Varian Medical Systems
Information provided by (Responsible Party):
Sk Shrivastava, Tata Memorial Hospital

Brief Summary:
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 or disease Intervention/treatment
Cancer of Cervix Radiation: IMRT

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Study Type : Observational
Actual Enrollment : 200 participants
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
Study Start Date : February 2005
Actual Primary Completion Date : June 20, 2017
Actual Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer

Group/Cohort Intervention/treatment
Patients with histologically proven, cervical cancer FIGO Stage IIB eligible will be invited for the study. The patients will recieve either 3D conformal radiation or IMRT external radiation with concomitant cisplatin chemotherapy followed by brachytherapy.
Radiation: IMRT
IMRT in cervical cancers

Primary Outcome Measures :
  1. To compare the normal tissue toxicities (Acute & Late) of standard radiation therapy with IMRT [ Time Frame: 2017 ]

Secondary Outcome Measures :
  1. To compare the disease free survivals [ Time Frame: 2017 ]
  2. To compare the quality of life in both the groups [ Time Frame: 2017 ]
  3. To compare the overall survivals [ Time Frame: 2017 ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes 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

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00193804

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Tata Memorial Hospital
Mumbai, Maharastra, India, 400 012
Sponsors and Collaborators
Tata Memorial Hospital
Varian Medical Systems
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Principal Investigator: Shyamkishore J Shrivastava, MD, DNB (RT) Professor & Head, Radiation Oncology, Tata Memorial Hospital
Additional Information:
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Responsible Party: Sk Shrivastava, Prof. & Head of Radiation Oncology, Tata Memorial Hospital Identifier: NCT00193804    
Other Study ID Numbers: TMH/158/2004/Cx_IMRT TRIAL
First Posted: September 19, 2005    Key Record Dates
Last Update Posted: September 16, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Sk Shrivastava, Tata Memorial Hospital:
Cervical Cancer
Intensity Modulated Radiation Therapy(IMRT)
Conventional Radiation Therapy
Cancer of the Cervix
Cervix Cancer
Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Genital Diseases