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Comparing Study Between Concurrent Chemoradiation and New Combination Treatment in Cervical Cancer Patients (TGOCphaseIII)

This study is currently recruiting participants.
Verified March 2010 by Thai Gynecologic Oncology Collaborative Group
Sponsor:
ClinicalTrials.gov Identifier:
NCT01000415
First Posted: October 23, 2009
Last Update Posted: June 24, 2010
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
National Research Council of Thailand
Clinical Research Collaborative Network
Information provided by:
Thai Gynecologic Oncology Collaborative Group
  Purpose

The purpose of this study is:

  • to compare the effectiveness between the new strategy of treatment (given cis-platinum plus gemcitabine-neoadjuvant chemotherapy followed by surgery),and standard treatment (given cis-platinum/carboplatin during radiation-concurrent chemoradiation)in specific group of cervical cancer patients (stage Ib2-early IIb)
  • to evaluate quality of life in both group of patients(standard treatment vs.experimental group)

Condition Intervention Phase
Cervical Cancer Other: Neoadjuvant chemotherapy followed by surgery Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparing Standard Concurrent Chemo-radiation to Neoadjuvant Chemotherapy Then Surgery or Radiation in Patients Stage Ib2-early IIb Cervical Carcinoma

Resource links provided by NLM:


Further study details as provided by Thai Gynecologic Oncology Collaborative Group:

Primary Outcome Measures:
  • Overall survival comparison between experimental treatment group and standard treatment group [ Time Frame: 9 Years ]

Secondary Outcome Measures:
  • Comparing disease free survival between experimental treatment group and standard treatment group [ Time Frame: 9 years ]

Estimated Enrollment: 824
Study Start Date: June 2009
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cisplatin plus gemcitabine
Experimental arm: neoadjuvant chemotherapy (cisplatin plus gemcitabine) followed by surgery Control arm: concurrent chemoradiation (cisplatin/carboplatin)during standard radiation
Other: Neoadjuvant chemotherapy followed by surgery
Cisplatin 50 mg/m2 (in the vein)on day 1 of each 23 day cycle plus gemcitabine 1000 mg/m2 (in the vein) on day 1 and day 8, for 3 cycles: until progression or unacceptable toxicity develops.
Other Names:
  • Platinol,Platinol-AQ
  • Gemzar

Detailed Description:
According to FIGO classification of cervical cancer, stage Ib2 was classified as clinically visible lesion more than 4.0 cm in greatest dimension and stage IIb was classified tumor invades parametrium must not to pelvic wall. These were the common stages in Thai cervical cancer patients,and made a troublesome effect to Thai women. According to this study,stage early IIb with 1/3 of parametrium involvement. Mostly these two stage was treated with concurrent chemoradiation, challenging the possibility of late sequelae of radiation effect. This specific group of patients can be avoid the referred side effect by using neoadjuvant chemotherapy followed by radical hysterectomy with pelvic lymphadenectomy and para-aortic node sampling in operable cases (at least partial response- PR) and concurrent chemoradiation (CCR) in inoperable cases (less than PR). Due to high risk type of these subspecific group, combination chemotherapy instead of single chemotherapy was used as CCR. However in operable cases with identified poor prognostic factor should be receive post operative radiation as the usual manner.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Cervical cancer patients with FIGO stage Ib2-early IIb
  • Pathological proven squamous cell carcinoma or adenocarcinoma or adenosquamous cell carcinoma
  • ECOG performance status 0-1
  • No previous treatment for cervical cancer
  • Acceptable hematological,renal,liver function

Exclusion Criteria:

  • Previous history of cancer
  • Underlying disease not fit for surgery
  • Psychological problem
  • Obvious pelvic/para-aortic node involvement
  • Pregnancy
  • HIV positive
  • History of bowel obstruction
  Contacts and Locations
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): NCT01000415


Contacts
Contact: Saibua B. Chichareon, MD. 66 74 451201 saibua.c@psu.ac.th
Contact: Chutaporn - Dampan, BSc 66 74 451201 djutapor@medicine.psu.ac.th

Locations
Thailand
Gynecologic Oncology Unit, Department of Obstertrics and Gynecology, Faculty of medicine, Prince of Songkla University Recruiting
Hat-Yai, Songkhla, Thailand, 90110
Contact: Rakchai - Buhachat, MD.    66 74 451201    brakchai@medicine.psu.ac.th   
Contact: Chutaporn - Dampan, BSc.    66 74 451201    djutapor@medicine.psu.ac.th   
Principal Investigator: Rakchai - Buhachat, MD.         
Sponsors and Collaborators
Thai Gynecologic Oncology Collaborative Group
National Research Council of Thailand
Clinical Research Collaborative Network
Investigators
Principal Investigator: Saibua B. Chichareon, MD. Thai Gynecologic Oncology Collaborative Group (TGOC)
  More Information

Publications:
Responsible Party: Thai Gynecologic Oncology Collaborative Group
ClinicalTrials.gov Identifier: NCT01000415     History of Changes
Other Study ID Numbers: TGOC-03
ECPSU-522231012
First Submitted: October 21, 2009
First Posted: October 23, 2009
Last Update Posted: June 24, 2010
Last Verified: March 2010

Keywords provided by Thai Gynecologic Oncology Collaborative Group:
Stage Ib2-early IIb of cervical cancer
Neoadjuvant chemotherapy
Cisplatin plus gemcitabine
Radical hysterectomy with pelvic lymphadenectomy
Quality of life
Stage Ib2-IIb of cervical cancer patients

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Gemcitabine
Cisplatin
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs