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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2015 by Tata Memorial Hospital
Information provided by (Responsible Party):
Sudeep Gupta, Tata Memorial Hospital Identifier:
First received: September 11, 2005
Last updated: November 6, 2015
Last verified: November 2015
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
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
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 [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    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.

Secondary Outcome Measures:
  • Over all survival [ Time Frame: 7 years ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 730
Study Start Date: September 2003
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)
Drug: NACT
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.
Drug: Inj.Cisplatin
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)

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

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
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00193739

Contact: Sudeep Gupta, MD, DM + 91 22 24177201
Contact: Shyam K Shrivastava, MD + 91 22 24177163

Tata Memorial Hospital Recruiting
Mumbai, Maharashtra, India, 400012
Contact: Rohini Hawaldar    + 91 22 24177000 ext 4265   
Contact: Amita Maheshwari, MD    + 91 22 24177191   
Sub-Investigator: Amita Maheshwari, MD         
Sub-Investigator: Rajendra Kerkar, MD, MRCOG         
Sub-Investigator: Sarbani G Laskar, MD         
Sub-Investigator: Umesh Mahantshetty, MD         
Sub-Investigator: Seema A Gulia, MD,DM         
Sponsors and Collaborators
Sudeep Gupta
Principal Investigator: Sudeep Gupta, MD, DM Tata Memorial Hospital, Mumbai-400012,India
Principal Investigator: Shyam K Shrivastava, MD Tata Memorial Hospital, Mumbai-400012, India
  More Information

No publications provided

Responsible Party: Sudeep Gupta, Professor of medical oncology, Tata Memorial Hospital Identifier: NCT00193739     History of Changes
Other Study ID Numbers: 119 of 2003
Study First Received: September 11, 2005
Last Updated: November 6, 2015
Health Authority: India: Department of Atomic Energy

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

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Genital Diseases, Female
Genital Neoplasms, Female
Neoplasms by Site
Urogenital Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Uterine Neoplasms processed this record on November 24, 2015