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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 : October 24, 2017
Sponsor:
Information provided by (Responsible Party):
Sudeep Gupta, Tata Memorial Hospital

Brief Summary:
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 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

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 635 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Actual Study Start Date : September 4, 2003
Estimated Primary Completion Date : July 31, 2019
Estimated Study Completion Date : July 31, 2019

Arm Intervention/treatment
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)




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. Rate of Distant Metastases [ Time Frame: 7 years ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes 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.
  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.

Information from the National Library of Medicine

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


Locations
India
Tata Memorial Hospital
Mumbai, Maharashtra, India, 400012
Sponsors and Collaborators
Tata Memorial Hospital
Investigators
Principal Investigator: Sudeep Gupta, MD, DM Tata Memorial Hospital, Mumbai-400012,India
Principal Investigator: Shyam K Shrivastava, MD Tata Memorial Hospital, Mumbai-400012, India

Additional Information:
Publications:
928O_PRNeoadjuvant chemotherapy followed by surgery (NACT-surgery) versus concurrent cisplatin and radiation therapy (CTRT) in patients with stage IB2 to IIB squamous carcinoma of cervix: A randomized controlled trial (RCT) S. Gupta P. Parab R. Kerkar U. Mahantshetty A. Maheshwari S. SastriR. Engineer R. Hawaldar J. Ghosh S. Gulia ... Show more Annals of Oncology, Volume 28, Issue suppl_5, 1 September 2017, mdx440.038,https://doi.org/10.1093/annonc/mdx440.038 Published: 18 September 2017

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sudeep Gupta, Professor of Medical Oncology, Tata Memorial Hospital
ClinicalTrials.gov Identifier: NCT00193739     History of Changes
Other Study ID Numbers: 119 of 2003
First Posted: September 19, 2005    Key Record Dates
Last Update Posted: October 24, 2017
Last Verified: October 2017

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

Additional relevant MeSH terms:
Genital Diseases, Female
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Paclitaxel
Cisplatin
Carboplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action