NCT01000415

Brief Summary

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)

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
824

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jun 2009

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 21, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 23, 2009

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
4.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

June 24, 2010

Status Verified

March 1, 2010

Enrollment Period

4.3 years

First QC Date

October 21, 2009

Last Update Submit

June 23, 2010

Conditions

Cervical Cancer

Keywords

Stage Ib2-early IIb of cervical cancerNeoadjuvant chemotherapyCisplatin plus gemcitabineRadical hysterectomy with pelvic lymphadenectomyQuality of lifeStage Ib2-IIb of cervical cancer patients

Outcome Measures

Primary Outcomes (1)

  • Overall survival comparison between experimental treatment group and standard treatment group

    9 Years

Secondary Outcomes (1)

  • Comparing disease free survival between experimental treatment group and standard treatment group

    9 years

Study Arms (1)

Cisplatin plus gemcitabine

EXPERIMENTAL

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

Interventions

Neoadjuvant chemotherapy followed by surgeryOTHER

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.

Also known as: Platinol,Platinol-AQ, Gemzar
Cisplatin plus gemcitabine

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gynecologic Oncology Unit, Department of Obstertrics and Gynecology, Faculty of medicine, Prince of Songkla University

Hat Yai, Changwat Songkhla, 90110, Thailand

RECRUITING

Related Publications (1)

  • Termrungruanglert W, Tresukosol D, Vasuratna A, Sittisomwong T, Lertkhachonsuk R, Sirisabya N. Neoadjuvant gemcitabine and cisplatin followed by radical surgery in (bulky) squamous cell carcinoma of cervix stage IB2. Gynecol Oncol. 2005 May;97(2):576-81. doi: 10.1016/j.ygyno.2005.01.048.

    PMID: 15863162BACKGROUND

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

CisplatinGemcitabine

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

Chlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsHeterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Saibua B. Chichareon, MD.

    Thai Gynecologic Oncology Collaborative Group (TGOC)

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Saibua B. Chichareon, MD.

CONTACT

66 74 451201saibua.c@psu.ac.th

Chutaporn - Dampan, BSc

CONTACT

66 74 451201djutapor@medicine.psu.ac.th

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NETWORK

Study Record Dates

First Submitted

October 21, 2009

First Posted

October 23, 2009

Study Start

June 1, 2009

Primary Completion

September 1, 2013

Study Completion

June 1, 2018

Last Updated

June 24, 2010

Record last verified: 2010-03

Locations

TH(1)