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
Recruitment status was Recruiting
Sponsor:
Tata Memorial Hospital
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
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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
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
Additional 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 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 June 18, 2013