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Uterine Cervical CancerPhase 3ACT-LACCNCT02036164

Adjuvant Chemotherapy for Locally Advanced Cervical Cancer

A Phase 3 study testing Pelvic radiation, Cisplatin and Paclitaxel in people with Uterine Cervical Cancer, run by Siriwan Tangjitgamol, MD at 11 sites in Thailand.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years, women only
Conditions the study is for
Uterine Cervical Cancer
What is being tested?
Pelvic radiation, Cisplatin and Paclitaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
500 participants
Where
11 sitesThailand
Study dates
Jan 2014to Jan 2019
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

11 sites in 1 country.

Siriwan Tangjitgamol, MD contact

66-86-3841431

siriwanonco@yahoo.com

Vichan Lordvithaya, MD contact

6681-6814367

vilorvid@yahoo.com

11 sites in 1 country

Thailand11 sites, 10 recruiting

  • Bhumibol Adulyadej Hospital

    Bangkok, Bangkok, 10220

    Piyawan Pariyawateekul, MD, 6689-0353777, nootpiya@hotmail.com

    Apiradee Kridakara, MD, 66-86-3671487, akrid7@hotmail.com

    Recruiting

  • Department of Obstetrics and Gynecology, Department of Radiology, Epidemiology Unit, Navamindradhiraj University

    Bangkok, Bangkok, 10300

    Siriwan Tangjitgamol, MD, 66-86-3841431, siriwanonco@yahoo.com

    Kanisa Rongsriyam, MD, 66-8181-68789, kanisa_r@hotmail.com

    Recruiting

  • Health Intervention and Technology Assessment Program

    Bangkok, Bangkok, 11000

    Yot Teerawattananon, MD, 66-84-6760080, yot.t@hitap.net

    Yot Teerawattananon, MD

    Not yet recruiting

  • Department of Radiology, Department of Obstetrics and Gynecology, Chiang Mai University

    Chiang Mai, Chiang Mai, 50200

    Ekkasit Tharavijitkul, MD, 966-89-4338709, paan_31@hotmail.com

    Ekkasit Tharavijitkul, MD

    Recruiting

  • Chonburi Cancer Hospital

    Chon Buri, Changwat Chon Buri, 20000

    Chokaew Tovanabutra, MD, 66-81-4726633, chokaewt@hotmail.com

    Chokaew Tovanabutra, MD

    Recruiting

  • Lampang Cancer Hospital

    Lampang, Changwat Lampang, 52000

    Tussawan Asakit, MD, 66-81-6715013, tussawan_a1@hotmail.com

    Tussawan Asakit, MD

    Recruiting

  • Lopburi Cancer Hospital

    Lopburi, Changwat Lop Buri, 15000

    Jirasak Sukhaboon, MD, 66-89-7970600, fodjiji@gmail.com

    Jirasak Sukhaboon, MD

    Recruiting

  • Ratchaburi Hospital

    Muang, Changwat Ratchaburi, 70000

    Active, not recruiting

  • Department of Obstetrics and Gynecology, Department of Radiology, Prince of Songkla University

    Songkhla, Changwat Songkhla, 90110

    Thiti Atjimakul, MD, 6681-2773793, thitiatjimakul@yahoo.com

    Jitti Hanprasertpong, MD, 66-89-6540214, hjitti@medicine.psu.ac.th

    Recruiting

  • Ubonratchathani Cancer Hospital

    Ubonratchathani, Ubonratchathani, 34000

    Taywin Chottetanaprasith, MD, 66-81-9359756, taywinc@hotmail.com

    Taywin Chottetanaprasith, MD

    Recruiting

  • Udonthani Cancer Hopital

    Udon Thani, Udonthani, 41330

    Sirentra Wanglikitkoon, MD, 6684-6570028, sirentra@hotmail.com

    Sirentra Wanglikitkoon, MD

    Recruiting

Other trials in Thailand

About this study

Official title: 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.

Read the 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.

Being tested
Pelvic radiation, Cisplatin, Paclitaxel, Carboplatin
Keywords
Locally advanced cervical cancer, Concurrent chemoradiation, Adjuvant chemotherapy
Medical subject headings
Uterine Cervical Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pelvic radiationRadiation

    Also called External beam pelvic radiation therapy and brachytherapy

    Radiation:

    • Pelvic radiation 1.8 Gy/ day, 5 days/ week, 6 weeks
    • Brachytherapy 30-35 Gy for 4-5 times

  • CisplatinDrug

    Also called Drugs:, - Cisplatin, - Kemoplat®, - Platin®

    Cisplatin 40 mg/m2 i.v.

  • PaclitaxelDrug

    Also called - Intaxel®, - Anzatax®

    Paclitaxel 175 mg m2 i.v.

  • CarboplatinDrug

    Also called - Carboplatin®, - Kemocarb®

    Carboplatin AUC 5 i.v.

Study groups in NCT02036164
Study groupRoleWhat they receive
Concurrent chemoradiationActive comparatorRadiation: 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
Receives: Radiation: Pelvic radiation; Drug: Cisplatin
Concurretn chemoradiation plus adjuvant chemotherapyExperimentalRadiation: 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
Receives: Radiation: Pelvic radiation; Drug: Cisplatin; Drug: Paclitaxel; Drug: Carboplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free survival

    3-year progression free survival

    Measured: 3 years

Secondary outcomes (1)

  1. Overall survival

    3-year overall survival

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jan 2014 (estimated)
  2. Study startJan 2014
  3. Primary completionJan 2018 (estimated)
  4. Study completionJan 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02036164
Sponsor's protocol ID
COA-CREC 002/2013
Other IDs
20140106001
Acronym
ACT-LACC
Status last verified
Apr 2017
First submitted
8 Jan 2014
Last updated
6 Apr 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • Tangjitgamol S, Tharavichitkul E, Tovanabutra C, Rongsriyam K, Asakij T, Paengchit K, Sukhaboon J, Penpattanagul S, Kridakara A, Hanprasertpong J, Chomprasert K, Wanglikitkoon S, Atjimakul T, Pariyawateekul P, Katanyoo K, Tanprasert P, Janweerachai W, Sangthawan D, Khunnarong J, Chottetanaprasith T, Supawattanabodee B, Lertsanguansinchai P, Srisomboon J, Isaranuwatchai W, Lorvidhaya V. A randomized controlled trial comparing concurrent chemoradiation versus concurrent chemoradiation followed by adjuvant chemotherapy in locally advanced cervical cancer patients: ACTLACC trial. J Gynecol Oncol. 2019 Jul;30(4):e82. doi: 10.3802/jgo.2019.30.e82. Epub 2019 Apr 10.

    PubMed 31074236

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Pelvic radiation, Cisplatin and Paclitaxel in people with Uterine Cervical Cancer, run by Siriwan Tangjitgamol, MD at 11 sites in Thailand.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 6 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Siriwan Tangjitgamol, MD (66-86-3841431, siriwanonco@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02036164, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2017.

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