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

April 4, 2017 updated by: Siriwan Tangjitgamol, MD

Randomized Controlled Trial Comparing Concurrent Chemoradiation Versus Concurrent Chemoradiation Followed by Adjuvant Chemotherapy in Locally Advanced Cervical Cancer Patients

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

500

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Thailand
      • Bangkok, Thailand, 10220
        • Recruiting
        • Bhumibol Adulyadej Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Piyawan Pariyawateekul, MD
        • Principal Investigator:
          • Apiradee Kridakara, MD
      • Bangkok, Thailand, 10300
        • Recruiting
        • Department of Obstetrics and Gynecology, Department of Radiology, Epidemiology Unit, Navamindradhiraj University
        • Contact:
        • Contact:
        • 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
      • Bangkok, Thailand, 11000
        • Not yet recruiting
        • Health Intervention and Technology Assessment Program
        • Contact:
          • Yot Teerawattananon, MD
          • Phone Number: 66-84-6760080
          • Email: yot.t@hitap.net
        • Principal Investigator:
          • Yot Teerawattananon, MD
      • Chiang Mai, Thailand, 50200
        • Recruiting
        • Department of Radiology, Department of Obstetrics and Gynecology, Chiang Mai University
        • Contact:
        • Principal Investigator:
          • Ekkasit Tharavijitkul, MD
        • Sub-Investigator:
          • Vichan Lordvithaya, MD
        • Sub-Investigator:
          • Jatupol Srisomboon, MD
      • Chonburi, Thailand, 20000
        • Recruiting
        • Chonburi Cancer Hospital
        • Contact:
        • Principal Investigator:
          • Chokaew Tovanabutra, MD
        • Sub-Investigator:
          • Kittisak Chomprasert, MD
      • Lampang, Thailand, 52000
        • Recruiting
        • Lampang Cancer Hospital
        • Contact:
        • Principal Investigator:
          • Tussawan Asakit, MD
        • Sub-Investigator:
          • Kannika Paengchit, MD
      • Lopburi, Thailand, 15000
        • Recruiting
        • Lopburi Cancer Hospital
        • Contact:
        • Principal Investigator:
          • Jirasak Sukhaboon, MD
        • Sub-Investigator:
          • Panit Chiewaratanapong, MD
      • Songkla, Thailand, 90110
        • Recruiting
        • Department of Obstetrics and Gynecology, Department of Radiology, Prince of Songkla University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Thiti Atjimakul, MD
        • Principal Investigator:
          • Duangjai Sangthawan, MD
        • Sub-Investigator:
          • Jitti hanprasertpong, MD
      • Ubonratchathani, Thailand, 34000
        • Recruiting
        • Ubonratchathani Cancer Hospital
        • Contact:
        • Principal Investigator:
          • Taywin Chottetanaprasith, MD
        • Sub-Investigator:
          • Metee Wongsena, MD
      • Udonthani, Thailand, 41330
        • Recruiting
        • Udonthani Cancer Hopital
        • Contact:
        • Principal Investigator:
          • Sirentra Wanglikitkoon, MD
        • Sub-Investigator:
          • Somkit Penpattanagul, MD
    • Ratchaburi
      • Muang, Ratchaburi, Thailand, 70000
        • Active, not recruiting
        • Ratchaburi Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival
Time Frame: 3 years
3-year progression free survival
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 3 years
3-year overall survival
3 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
4 months after completion of CCRT
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
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
Adverse event
Time Frame: up to 6 months after treatment
Adverse events occurred during and after treatment
up to 6 months after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Siriwan Tangjitgamol, MD

Collaborators

Prince of Songkla University
National Research Council of Thailand
Chiang Mai University
Navamindradhiraj 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (ANTICIPATED)

January 1, 2018

Study Completion (ANTICIPATED)

January 1, 2019

Study Registration Dates

First Submitted

January 8, 2014

First Submitted That Met QC Criteria

January 12, 2014

First Posted (ESTIMATE)

January 14, 2014

Study Record Updates

Last Update Posted (ACTUAL)

April 6, 2017

Last Update Submitted That Met QC Criteria

April 4, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COA-CREC 002/2013
  • 20140106001 (REGISTRY: TCTR)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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