Neoadjuvant Chemotherapy Followed by Surgery Versus Concurrent Chemoradiation in Carcinoma of the Cervix (NACTcervix)
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|ClinicalTrials.gov Identifier: NCT00193739|
Recruitment Status : Active, not recruiting
First Posted : September 19, 2005
Last Update Posted : September 20, 2019
|Condition or disease||Intervention/treatment||Phase|
|Cancer of Cervix||Drug: NACT Procedure: Radical abdominal hysterectomy (class III), BPLND & lower para aortic lymph node sampling Drug: Inj.Cisplatin Radiation: Concurrent chemo radiotherapy||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||635 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prospective Randomized Trial of Neoadjuvant Chemotherapy and Surgery Versus Concurrent Chemoradiation Therapy in Patients With Stage IB2-IIB Squamous Carcinoma of the Uterine Cervix|
|Actual Study Start Date :||September 4, 2003|
|Estimated Primary Completion Date :||July 31, 2020|
|Estimated Study Completion Date :||July 31, 2020|
Active Comparator: NACT followed by surgery
3 cycles of neoadjuvant chemotherapy (NACT) (Inj.Paclitaxel +Inj.Carboplatin) followed by surgery (radical abdominal hysterectomy Class III , bilateral pelvic lymphadenectomy & lower para aortic lymph node sampling)
3 cycles of neoadjuvant chemotherapy
Other Name: Neoadjuvant chemotherapy (Inj.Paclitaxel + Inj.Carboplatin)
Procedure: Radical abdominal hysterectomy (class III), BPLND & lower para aortic lymph node sampling
NACT followed by surgery
Other Name: Radical abdominal hysterectomy (class III), bilateral pelvic lymphadenectomy & lower para aortic lymph node sampling
Active Comparator: Concurrent chemoradiotherapy
Radiation therapy will be administered to whole pelvis followed by intracavitary brachytherapy. Patients will be given chemotherapy (Inj.Cisplatin) concurrently with external beam radiotherapy.
Concurrent chemo radiotherapy
Radiation: Concurrent chemo radiotherapy
Radiation therapy will be administered to the whole pelvis region followed by intracavitary brachytherapy.
Other Name: External beam radiotherapy followed by intracavitary brachytherapy. (EBRT + ICA)
- Disease Free Survival [ Time Frame: 5 years ]Disease free survival will be calculated from the date of entry into the study to the date of first physical or radiographic evidence disease relapse or death due to disease or last follow up visit.
- Over all survival [ Time Frame: 7 years ]Over all survival will be calculated from the date of entry into the study to the date of death due to any cause or the last follow up visit.
- Rate of Distant Metastases [ Time Frame: 7 years ]
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): NCT00193739
|Tata Memorial Hospital|
|Mumbai, Maharashtra, India, 400012|
|Principal Investigator:||Sudeep Gupta, MD, DM||Tata Memorial Hospital, Mumbai-400012,India|
|Principal Investigator:||Shyam K Shrivastava, MD||Tata Memorial Hospital, Mumbai-400012, India|