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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2010 by Thai Gynecologic Oncology Collaborative Group
Sponsor:
Collaborators:
National Research Council of Thailand
Clinical Research Collaborative Network
Information provided by:
Thai Gynecologic Oncology Collaborative Group
ClinicalTrials.gov Identifier:
NCT01000415
First received: October 21, 2009
Last updated: June 23, 2010
Last verified: March 2010
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]

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

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

Ages Eligible for Study:   18 Years to 60 Years
Genders 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
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 ClinicalTrials.gov identifier: NCT01000415

Contacts
Contact: Saibua B. Chichareon, MD. 66 74 451201 ext - saibua.c@psu.ac.th
Contact: Chutaporn - Dampan, BSc 66 74 451201 ext - 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 ext -    brakchai@medicine.psu.ac.th   
Contact: Chutaporn - Dampan, BSc.    66 74 451201 ext -    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
Study First Received: October 21, 2009
Last Updated: June 23, 2010
Health Authority: Thailand: Ethical Committee
Thailand: Food and Drug Administration

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
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 19, 2014