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ACT-LACC: Adjuvant Chemotherapy for Locally Advanced Cervical Cancer

Sponsor
Siriwan Tangjitgamol, MD (Other)
Overall Status
Unknown status
CT.gov ID
NCT02036164
Collaborator
National Research Council of Thailand (Other), Navamindradhiraj University (Other), Chiang Mai University (Other), Prince of Songkla University (Other), Bhumibol Adulyadej Hospital (Other), Lopburi Cancer Hospital (Other), Ubonratchathani Cancer Hospital (Other), Udonthani Cancer Hospital (Other), Chonburi Cancer Hospital (Other), Lampang Cancer Hospital (Other), Health Intervention and Technology Assessment Program (Other), Rajburi Hospital (Other)
500
Enrollment
11
Locations
2
Arms
60
Duration (Months)
45.5
Patients Per Site
0.8
Patients Per Site Per Month

Study Details

Study Description

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
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.

Study Design

Study Type:
Interventional
Anticipated 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 :
Jan 1, 2014
Anticipated Primary Completion Date :
Jan 1, 2018
Anticipated Study Completion Date :
Jan 1, 2019

Arms and Interventions

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 Names:
  • 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 Names:
  • 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®

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Progression-free survival [3 years]

      3-year progression free survival

    Secondary Outcome Measures

    1. Overall survival [3 years]

      3-year overall survival

    Other Outcome Measures

    1. Response rate [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 [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 [up to 6 months after treatment]

      Adverse events occurred during and after treatment

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ratchaburi Hospital Muang Ratchaburi Thailand 70000
    2 Bhumibol Adulyadej Hospital Bangkok Thailand 10220
    3 Department of Obstetrics and Gynecology, Department of Radiology, Epidemiology Unit, Navamindradhiraj University Bangkok Thailand 10300
    4 Health Intervention and Technology Assessment Program Bangkok Thailand 11000
    5 Department of Radiology, Department of Obstetrics and Gynecology, Chiang Mai University Chiang Mai Thailand 50200
    6 Chonburi Cancer Hospital Chonburi Thailand 20000
    7 Lampang Cancer Hospital Lampang Thailand 52000
    8 Lopburi Cancer Hospital Lopburi Thailand 15000
    9 Department of Obstetrics and Gynecology, Department of Radiology, Prince of Songkla University Songkla Thailand 90110
    10 Ubonratchathani Cancer Hospital Ubonratchathani Thailand 34000
    11 Udonthani Cancer Hopital Udonthani Thailand 41330

    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

    • Principal Investigator: Siriwan Tangjitgamol, MD, Navamindradhiraj University
    • Principal Investigator: Vichan Lordvithaya, MD, ChaingMai University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Siriwan Tangjitgamol, MD, Doctor, Navamindradhiraj University
    ClinicalTrials.gov Identifier:
    NCT02036164
    Other Study ID Numbers:
    • COA-CREC 002/2013
    • 20140106001
    First Posted:
    Jan 14, 2014
    Last Update Posted:
    Apr 6, 2017
    Last Verified:
    Apr 1, 2017
    Keywords provided by Siriwan Tangjitgamol, MD, Doctor, Navamindradhiraj University
    Locally advanced cervical cancer
    Concurrent chemoradiation
    Adjuvant chemotherapy
    Additional relevant MeSH terms:
    Uterine Cervical Neoplasms
    Paclitaxel
    Cisplatin
    Carboplatin

    Study Results

    No Results Posted as of Apr 6, 2017