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. |
ClinicalTrials.gov Identifier: NCT00193804 |
Recruitment Status :
Completed
First Posted : September 19, 2005
Last Update Posted : September 16, 2019
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment |
---|---|
Cancer of Cervix | Radiation: IMRT |
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 |
Group/Cohort | Intervention/treatment |
---|---|
2
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 |
- To compare the normal tissue toxicities (Acute & Late) of standard radiation therapy with IMRT [ Time Frame: 2017 ]
- To compare the disease free survivals [ Time Frame: 2017 ]
- To compare the quality of life in both the groups [ Time Frame: 2017 ]
- To compare the overall survivals [ Time Frame: 2017 ]
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.
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 |
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.
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 ClinicalTrials.gov identifier (NCT number): NCT00193804
India | |
Tata Memorial Hospital | |
Mumbai, Maharastra, India, 400 012 |
Principal Investigator: | Shyamkishore J Shrivastava, MD, DNB (RT) | Professor & Head, Radiation Oncology, Tata Memorial Hospital |
Responsible Party: | Sk Shrivastava, Prof. & Head of Radiation Oncology, Tata Memorial Hospital |
ClinicalTrials.gov 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 |
Cervical Cancer FIGO STAGE IIB CHEMORADIATION Intensity Modulated Radiation Therapy(IMRT) |
Conventional Radiation Therapy Cancer of the Cervix Cervix Cancer |
Uterine Cervical Neoplasms 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 |