Neoadjuvant Chemotherapy Followed by Surgery Versus Concurrent Chemoradiation in Carcinoma of the Cervix

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2007 by Tata Memorial Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Tata Memorial Hospital
ClinicalTrials.gov Identifier:
NCT00193739
First received: September 11, 2005
Last updated: September 25, 2007
Last verified: September 2007
  Purpose

Carcinoma cervix is a common malignancy in women in developing countries including India. The standard treatment of locally advanced cervical cancer (Stages IB2 to IIIB)is concomitant chemoradiation (CT RT) using platinum based chemotherapy. Some studies, including a meta-analysis conducted by the Cochrane group, have indicated that few courses of neoadjuvant chemotherapy (NACT) followed by surgery may be superior to radical radiation alone for these patients. However NACT-Surgery approach has never been compared to the current standard of concomitant CT RT. The present study is undertaken to compare, in a randomized trial, NACT(3 courses of paclitaxel-carboplatin) followed by surgery to concomitant CT RT in stages IB2 to IIB squamous cell carcinoma of the uterine cervix.


Condition Intervention Phase
Cancer of Cervix
Procedure: Radical Hysterectomy
Drug: Paclitaxel
Drug: Carboplatin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Tata Memorial Hospital:

Primary Outcome Measures:
  • Disease Free Survival
  • Overall Survival

Secondary Outcome Measures:
  • Rate of Distant Metastases
  • Morbidity

Estimated Enrollment: 730
Study Start Date: September 2003
Estimated Study Completion Date: September 2010
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Women with histologically proven invasive squamous cell carcinoma of the uterine cervix, stages IB2-IIB.
  2. Age 18-65 years (both inclusive)
  3. No evidence of visceral, skeletal or extra-abdominal nodal metastases.
  4. No history of prior or present second malignancy
  5. Good performance status (Karnofsky performance score > 70 or ECOG PS <2)
  6. Normal hematological & biochemical parameters including normal renal function (WBC count > 3500/cumm, platelet count > 100000 per cumm, Hb > 9 gm/dl, serum creatinine < 2 mg%, SGOT, SGPT less than 4 times the upper limit of normal, serum bilirubin < 1.5 mg%)
  7. Presence of associated co-morbid conditions that preclude participation in the study.
  8. No prior treatment.
  9. Informed consent for participation in the study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00193739

Contacts
Contact: Sudeep Gupta, MD, DM + 91 22 24177201 sudeepgupta04@yahoo.com
Contact: Hemant B Tongaonkar, MS + 91 22 24177275 hemarmi@vsnl.net

Locations
India
Tata Memorial Hospital Recruiting
Mumbai, Maharashtra, India, 400012
Contact: Rohini Hawaldar    + 91 22 24177000 ext 4265    tmhcrs@vsnl.com   
Contact: Amita Maheshwari, MD    + 91 22 24177191    maheshwariamita@yahoo.com   
Sub-Investigator: Ketayun A Dinshaw, DMRT, FRCR         
Sub-Investigator: Amita Maheshwari, MD         
Sub-Investigator: Rajendra Kerkar, MD, MRCOG         
Sub-Investigator: Sarbani G Laskar, MD         
Sub-Investigator: Umesh Mahantshetty, MD         
Sponsors and Collaborators
Tata Memorial Hospital
Investigators
Principal Investigator: Sudeep Gupta, MD, DM Tata Memorial Hospital, Mumbai-400012,India
Principal Investigator: Hemant B Tongaonkar, MS Tata Memorial Hospital, Mumbai-400012, India
Principal Investigator: Shyam K Shrivastava, MD Tata Memorial Hospital, Mumbai-400012, India
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00193739     History of Changes
Other Study ID Numbers: 119 of 2003
Study First Received: September 11, 2005
Last Updated: September 25, 2007
Health Authority: India: Department of Atomic Energy

Keywords provided by Tata Memorial Hospital:
Neoadjuvant chemotherapy
Surgery
Cervix cancer
Concurrent chemoradiation

Additional relevant MeSH terms:
Carcinoma
Uterine Cervical Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Carboplatin
Paclitaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on April 16, 2014