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Adjuvant Chemotherapy for Locally Advanced Cervical Cancer (ACT-LACC)

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ClinicalTrials.gov Identifier: NCT02036164
Recruitment Status : Unknown
Verified April 2017 by Siriwan Tangjitgamol, MD, Navamindradhiraj University.
Recruitment status was:  Recruiting
First Posted : January 14, 2014
Last Update Posted : April 6, 2017
Sponsor:
Collaborators:
National Research Council of Thailand
Navamindradhiraj University
Chiang Mai University
Prince of Songkla University
Bhumibol Adulyadej Hospital
Lopburi Cancer Hospital
Ubonratchathani Cancer Hospital
Udonthani Cancer Hospital
Chonburi Cancer Hospital
Lampang Cancer Hospital
Health Intervention and Technology Assessment Program
Rajburi Hospital
Information provided by (Responsible Party):
Siriwan Tangjitgamol, MD, Navamindradhiraj University

Brief Summary:
Data of survival benefit from adjuvant chemotherapy (ACT) after concurrent chemoradiation (CCRT) for locally advanced cervical cancer (LACC) are still limited and inconsistent. We will investigate if ACT has survival benefit over CCRT alone.

Condition or disease Intervention/treatment Phase
Uterine Cervical Cancer Radiation: Pelvic radiation Drug: Cisplatin Drug: Paclitaxel Drug: Carboplatin Phase 3

Detailed Description:

Concurrent chemoradiation (CCRT) is the standard treatment for cervical cancer of FIGO stage IIB-IVA or so called locally advanced cervical cancer (LACC). However, failure rate after treatment is still as high as 30% to 40%.

This is a multi-center randomized controlled trial which evaluates whether adjuvant chemotherapy (ACT) after CCRT will improve treatment outcome comparing to CCRT alone.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial Comparing Concurrent Chemoradiation Versus Concurrent Chemoradiation Followed by Adjuvant Chemotherapy in Locally Advanced Cervical Cancer Patients
Study Start Date : January 2014
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer

Arm Intervention/treatment
Active Comparator: Concurrent chemoradiation

Radiation: Radiation Therapy

  • External beam pelvic radiotherapy (45-50.4 Gy in 1.8 Gy fractions) delivered by Linear accelerator machine
  • Vaginal brachytherapy for 4-5 fractions

Chemotherapy: Cisplatin

- Cisplatin 40 mg/m2 i.v., q wk, 6 cycles during radiotherapy

Radiation: Pelvic radiation

Radiation:

  • Pelvic radiation 1.8 Gy/ day, 5 days/ week, 6 weeks
  • Brachytherapy 30-35 Gy for 4-5 times
Other Name: External beam pelvic radiation therapy and brachytherapy

Drug: Cisplatin
Cisplatin 40 mg/m2 i.v.
Other Names:
  • Drugs:
  • - Cisplatin
  • - Kemoplat®
  • - Platin®

Experimental: Concurretn chemoradiation plus adjuvant chemotherapy

Radiation: Radiation Therapy

  • External beam pelvic radiotherapy (45-50.4 Gy in 1.8 Gy fractions) delivered by Linear accelerator machine
  • Vaginal brachytherapy for 4-5 fractions

Chemotherapy: Cisplatin, paclitaxel, carboplatin

  • Cisplatin 40 mg/m2 i.v., q wk, 6 cycles during radiotherapy
  • Paclitaxel 175 mg/m2 i.v. q 4 wks, 3 cycles starting 4 week after completion of CCRT
  • Carboplatin AUC 5 i.v. q 4 wks, 3 cycles given together with paclitaxel
Radiation: Pelvic radiation

Radiation:

  • Pelvic radiation 1.8 Gy/ day, 5 days/ week, 6 weeks
  • Brachytherapy 30-35 Gy for 4-5 times
Other Name: External beam pelvic radiation therapy and brachytherapy

Drug: Cisplatin
Cisplatin 40 mg/m2 i.v.
Other Names:
  • Drugs:
  • - Cisplatin
  • - Kemoplat®
  • - Platin®

Drug: Paclitaxel
Paclitaxel 175 mg m2 i.v.
Other Names:
  • - Intaxel®
  • - Anzatax®

Drug: Carboplatin
Carboplatin AUC 5 i.v.
Other Names:
  • - Carboplatin®
  • - Kemocarb®




Primary Outcome Measures :
  1. Progression-free survival [ Time Frame: 3 years ]
    3-year progression free survival


Secondary Outcome Measures :
  1. Overall survival [ Time Frame: 3 years ]
    3-year overall survival


Other Outcome Measures:
  1. Response rate [ Time Frame: 4 months after completion of CCRT ]
    Response rate will be assessed at 4 months after completion of CCRT (expected to be at 4 months after CCRT in the control arm or at 1 month after completion of adjuvant chemotherapy in the study arm)

  2. Cost-utility analysis [ Time Frame: Cost of treatment and quality of life will be assessed at baseline, completion of CCRT, q month for 3 months after CCRT, after each cycle of ACT, 2 years after completion of treatment, and when there are tumor persistence, progression or recurrence ]
    Cost and quality of life

  3. Adverse event [ Time Frame: up to 6 months after treatment ]
    Adverse events occurred during and after treatment



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18-70 years
  • Cervical cancer FIGO stage IIB-IVA
  • Histopathology of squamous cell carcinoma, adenocarcinoma, or adenosquamous cell carcinoma
  • ECOG performance status 0-2
  • No history of other cancer except basal cell carcinoma
  • Adequate bone marrow function (WBC > or = 3,000/mm3, granulocytes > or = 1,500/mm3, platelet count > or = 100,000/mm3)
  • Bilirubin < 1.5 folds, SGOT/ SGPT < 1.5 folds of normal limit, creatinine clearance > or = 40 mg/dl
  • Consent to participate

Exclusion Criteria:

  • Para-aortic lymph node enlargement > 1 cm or suspicious for cancer metastasis from CT or MRI
  • Adnexal mass from physical examination or imaging study
  • Chronic illnesses e.g. renal failure/ impairment, peripheral or central neuropathy, uncontrolled diabetes mellitus, or HIV infection.
  • Pregnancy or lactation

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): NCT02036164


Contacts
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Contact: Siriwan Tangjitgamol, MD 66-86-3841431 siriwanonco@yahoo.com
Contact: Vichan Lordvithaya, MD 6681-6814367 vilorvid@yahoo.com

Locations
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Thailand
Ratchaburi Hospital Active, not recruiting
Muang, Ratchaburi, Thailand, 70000
Bhumibol Adulyadej Hospital Recruiting
Bangkok, Thailand, 10220
Contact: Piyawan Pariyawateekul, MD    6689-0353777    nootpiya@hotmail.com   
Contact: Apiradee Kridakara, MD    66-86-3671487    akrid7@hotmail.com   
Principal Investigator: Piyawan Pariyawateekul, MD         
Principal Investigator: Apiradee Kridakara, MD         
Department of Obstetrics and Gynecology, Department of Radiology, Epidemiology Unit, Navamindradhiraj University Recruiting
Bangkok, Thailand, 10300
Contact: Siriwan Tangjitgamol, MD    66-86-3841431    siriwanonco@yahoo.com   
Contact: Kanisa Rongsriyam, MD    66-8181-68789    kanisa_r@hotmail.com   
Principal Investigator: Siriwan Tangjitgamol, MD         
Principal Investigator: Kanisa Rongsriyam, MD         
Sub-Investigator: Jakkapan Khunnarong, MD         
Sub-Investigator: Sunamchok Srijaipracharoen, MD         
Sub-Investigator: Busaba Supawattanabodee, MSc         
Sub-Investigator: Suphakarn Techapongsatorn, MD         
Sub-Investigator: Kanyarat Katanyoo, MD         
Health Intervention and Technology Assessment Program Not yet recruiting
Bangkok, Thailand, 11000
Contact: Yot Teerawattananon, MD    66-84-6760080    yot.t@hitap.net   
Principal Investigator: Yot Teerawattananon, MD         
Department of Radiology, Department of Obstetrics and Gynecology, Chiang Mai University Recruiting
Chiang Mai, Thailand, 50200
Contact: Ekkasit Tharavijitkul, MD    966-89-4338709    paan_31@hotmail.com   
Principal Investigator: Ekkasit Tharavijitkul, MD         
Sub-Investigator: Vichan Lordvithaya, MD         
Sub-Investigator: Jatupol Srisomboon, MD         
Chonburi Cancer Hospital Recruiting
Chonburi, Thailand, 20000
Contact: Chokaew Tovanabutra, MD    66-81-4726633    chokaewt@hotmail.com   
Principal Investigator: Chokaew Tovanabutra, MD         
Sub-Investigator: Kittisak Chomprasert, MD         
Lampang Cancer Hospital Recruiting
Lampang, Thailand, 52000
Contact: Tussawan Asakit, MD    66-81-6715013    tussawan_a1@hotmail.com   
Principal Investigator: Tussawan Asakit, MD         
Sub-Investigator: Kannika Paengchit, MD         
Lopburi Cancer Hospital Recruiting
Lopburi, Thailand, 15000
Contact: Jirasak Sukhaboon, MD    66-89-7970600    fodjiji@gmail.com   
Principal Investigator: Jirasak Sukhaboon, MD         
Sub-Investigator: Panit Chiewaratanapong, MD         
Department of Obstetrics and Gynecology, Department of Radiology, Prince of Songkla University Recruiting
Songkla, Thailand, 90110
Contact: Thiti Atjimakul, MD    6681-2773793    thitiatjimakul@yahoo.com   
Contact: Jitti Hanprasertpong, MD    66-89-6540214    hjitti@medicine.psu.ac.th   
Principal Investigator: Thiti Atjimakul, MD         
Principal Investigator: Duangjai Sangthawan, MD         
Sub-Investigator: Jitti hanprasertpong, MD         
Ubonratchathani Cancer Hospital Recruiting
Ubonratchathani, Thailand, 34000
Contact: Taywin Chottetanaprasith, MD    66-81-9359756    taywinc@hotmail.com   
Principal Investigator: Taywin Chottetanaprasith, MD         
Sub-Investigator: Metee Wongsena, MD         
Udonthani Cancer Hopital Recruiting
Udonthani, Thailand, 41330
Contact: Sirentra Wanglikitkoon, MD    6684-6570028    sirentra@hotmail.com   
Principal Investigator: Sirentra Wanglikitkoon, MD         
Sub-Investigator: Somkit Penpattanagul, MD         
Sponsors and Collaborators
Siriwan Tangjitgamol, MD
National Research Council of Thailand
Navamindradhiraj University
Chiang Mai University
Prince of Songkla University
Bhumibol Adulyadej Hospital
Lopburi Cancer Hospital
Ubonratchathani Cancer Hospital
Udonthani Cancer Hospital
Chonburi Cancer Hospital
Lampang Cancer Hospital
Health Intervention and Technology Assessment Program
Rajburi Hospital
Investigators
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Principal Investigator: Siriwan Tangjitgamol, MD Navamindradhiraj University
Principal Investigator: Vichan Lordvithaya, MD ChaingMai University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Siriwan Tangjitgamol, MD, Doctor, Navamindradhiraj University
ClinicalTrials.gov Identifier: NCT02036164     History of Changes
Other Study ID Numbers: COA-CREC 002/2013
20140106001 ( Registry Identifier: TCTR )
First Posted: January 14, 2014    Key Record Dates
Last Update Posted: April 6, 2017
Last Verified: April 2017
Keywords provided by Siriwan Tangjitgamol, MD, Navamindradhiraj University:
Locally advanced cervical cancer
Concurrent chemoradiation
Adjuvant chemotherapy
Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Paclitaxel
Albumin-Bound Paclitaxel
Cisplatin
Carboplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action