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

Primary Purpose

Uterine Cervical Cancer

Status

Unknown status

Phase

Phase 3

Locations

Thailand

Study Type

Interventional

Intervention

Pelvic radiation

Cisplatin

Paclitaxel

Carboplatin

About this trial

This is an interventional treatment trial for Uterine Cervical Cancer focused on measuring Locally advanced cervical cancer, Concurrent chemoradiation, Adjuvant chemotherapy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Ratchaburi Hospital
Bhumibol Adulyadej HospitalRecruiting
Department of Obstetrics and Gynecology, Department of Radiology, Epidemiology Unit, Navamindradhiraj UniversityRecruiting
Health Intervention and Technology Assessment Program
Department of Radiology, Department of Obstetrics and Gynecology, Chiang Mai UniversityRecruiting
Chonburi Cancer HospitalRecruiting
Lampang Cancer HospitalRecruiting
Lopburi Cancer HospitalRecruiting
Department of Obstetrics and Gynecology, Department of Radiology, Prince of Songkla UniversityRecruiting
Ubonratchathani Cancer HospitalRecruiting
Udonthani Cancer HopitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Concurrent chemoradiation

Concurretn chemoradiation plus adjuvant chemotherapy

Arm Description

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

Outcomes

Primary Outcome Measures

Progression-free survival

3-year progression free survival

Secondary Outcome Measures

Overall survival

3-year overall survival

Full Information

NCT ID

NCT02036164

First Posted

January 8, 2014

Last Updated

April 4, 2017

Sponsor

Siriwan Tangjitgamol, MD

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

1. Study Identification

Unique Protocol Identification Number

NCT02036164

Brief Title

Adjuvant Chemotherapy for Locally Advanced Cervical Cancer

Acronym

ACT-LACC

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2017

Overall Recruitment Status

Unknown status

Study Start Date

January 2014 (undefined)

Primary Completion Date

January 2018 (Anticipated)

Study Completion Date

January 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Siriwan Tangjitgamol, MD

Collaborators

4. Oversight

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Uterine Cervical Cancer

Keywords

Locally advanced cervical cancer, Concurrent chemoradiation, Adjuvant chemotherapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Concurrent chemoradiation

Arm Type

Active Comparator

Arm Description

Arm Title

Concurretn chemoradiation plus adjuvant chemotherapy

Arm Type

Experimental

Arm Description

Intervention Type

Radiation

Intervention Name(s)

Pelvic radiation

Other Intervention Name(s)

External beam pelvic radiation therapy and brachytherapy

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Cisplatin

Other Intervention Name(s)

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

Intervention Description

Cisplatin 40 mg/m2 i.v.

Intervention Type

Drug

Intervention Name(s)

Paclitaxel

Other Intervention Name(s)

- Intaxel®, - Anzatax®

Intervention Description

Paclitaxel 175 mg m2 i.v.

Intervention Type

Drug

Intervention Name(s)

Carboplatin

Other Intervention Name(s)

- Carboplatin®, - Kemocarb®

Intervention Description

Carboplatin AUC 5 i.v.

Primary Outcome Measure Information:

Title

Progression-free survival

Description

3-year progression free survival

Time Frame

3 years

Secondary Outcome Measure Information:

Title

Overall survival

Description

3-year overall survival

Time Frame

3 years

Other Pre-specified Outcome Measures:

Title

Response rate

Description

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)

Time Frame

4 months after completion of CCRT

Title

Cost-utility analysis

Description

Cost and quality of life

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

Title

Adverse event

Description

Adverse events occurred during and after treatment

Time Frame

up to 6 months after treatment

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Siriwan Tangjitgamol, MD

Phone

66-86-3841431

siriwanonco@yahoo.com

First Name & Middle Initial & Last Name or Official Title & Degree

Vichan Lordvithaya, MD

Phone

6681-6814367

vilorvid@yahoo.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Siriwan Tangjitgamol, MD

Organizational Affiliation

Navamindradhiraj University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Vichan Lordvithaya, MD

Organizational Affiliation

ChaingMai University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Ratchaburi Hospital

City

Muang

State/Province

Ratchaburi

ZIP/Postal Code

70000

Country

Thailand

Individual Site Status

Active, not recruiting

Facility Name

Bhumibol Adulyadej Hospital

City

Bangkok

ZIP/Postal Code

10220

Country

Thailand

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Piyawan Pariyawateekul, MD

Phone

6689-0353777

nootpiya@hotmail.com

First Name & Middle Initial & Last Name & Degree

Apiradee Kridakara, MD

Phone

66-86-3671487

akrid7@hotmail.com

First Name & Middle Initial & Last Name & Degree

Piyawan Pariyawateekul, MD

First Name & Middle Initial & Last Name & Degree

Apiradee Kridakara, MD

Facility Name

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

City

Bangkok

ZIP/Postal Code

10300

Country

Thailand

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Siriwan Tangjitgamol, MD

Phone

66-86-3841431

siriwanonco@yahoo.com

First Name & Middle Initial & Last Name & Degree

Kanisa Rongsriyam, MD

Phone

66-8181-68789

kanisa_r@hotmail.com

First Name & Middle Initial & Last Name & Degree

Siriwan Tangjitgamol, MD

First Name & Middle Initial & Last Name & Degree

Kanisa Rongsriyam, MD

First Name & Middle Initial & Last Name & Degree

Jakkapan Khunnarong, MD

First Name & Middle Initial & Last Name & Degree

Sunamchok Srijaipracharoen, MD

First Name & Middle Initial & Last Name & Degree

Busaba Supawattanabodee, MSc

First Name & Middle Initial & Last Name & Degree

Suphakarn Techapongsatorn, MD

First Name & Middle Initial & Last Name & Degree

Kanyarat Katanyoo, MD

Facility Name

Health Intervention and Technology Assessment Program

City

Bangkok

ZIP/Postal Code

11000

Country

Thailand

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yot Teerawattananon, MD

Phone

66-84-6760080

yot.t@hitap.net

First Name & Middle Initial & Last Name & Degree

Yot Teerawattananon, MD

Facility Name

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

City

Chiang Mai

ZIP/Postal Code

50200

Country

Thailand

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ekkasit Tharavijitkul, MD

Phone

966-89-4338709

paan_31@hotmail.com

First Name & Middle Initial & Last Name & Degree

Ekkasit Tharavijitkul, MD

First Name & Middle Initial & Last Name & Degree

Vichan Lordvithaya, MD

First Name & Middle Initial & Last Name & Degree

Jatupol Srisomboon, MD

Facility Name

Chonburi Cancer Hospital

City

Chonburi

ZIP/Postal Code

20000

Country

Thailand

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Chokaew Tovanabutra, MD

Phone

66-81-4726633

chokaewt@hotmail.com

First Name & Middle Initial & Last Name & Degree

Chokaew Tovanabutra, MD

First Name & Middle Initial & Last Name & Degree

Kittisak Chomprasert, MD

Facility Name

Lampang Cancer Hospital

City

Lampang

ZIP/Postal Code

52000

Country

Thailand

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Tussawan Asakit, MD

Phone

66-81-6715013

tussawan_a1@hotmail.com

First Name & Middle Initial & Last Name & Degree

Tussawan Asakit, MD

First Name & Middle Initial & Last Name & Degree

Kannika Paengchit, MD

Facility Name

Lopburi Cancer Hospital

City

Lopburi

ZIP/Postal Code

15000

Country

Thailand

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jirasak Sukhaboon, MD

Phone

66-89-7970600

fodjiji@gmail.com

First Name & Middle Initial & Last Name & Degree

Jirasak Sukhaboon, MD

First Name & Middle Initial & Last Name & Degree

Panit Chiewaratanapong, MD

Facility Name

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

City

Songkla

ZIP/Postal Code

90110

Country

Thailand

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Thiti Atjimakul, MD

Phone

6681-2773793

thitiatjimakul@yahoo.com

First Name & Middle Initial & Last Name & Degree

Jitti Hanprasertpong, MD

Phone

66-89-6540214

hjitti@medicine.psu.ac.th

First Name & Middle Initial & Last Name & Degree

Thiti Atjimakul, MD

First Name & Middle Initial & Last Name & Degree

Duangjai Sangthawan, MD

First Name & Middle Initial & Last Name & Degree

Jitti hanprasertpong, MD

Facility Name

Ubonratchathani Cancer Hospital

City

Ubonratchathani

ZIP/Postal Code

34000

Country

Thailand

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Taywin Chottetanaprasith, MD

Phone

66-81-9359756

taywinc@hotmail.com

First Name & Middle Initial & Last Name & Degree

Taywin Chottetanaprasith, MD

First Name & Middle Initial & Last Name & Degree

Metee Wongsena, MD

Facility Name

Udonthani Cancer Hopital

City

Udonthani

ZIP/Postal Code

41330

Country

Thailand

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sirentra Wanglikitkoon, MD

Phone

6684-6570028

sirentra@hotmail.com

First Name & Middle Initial & Last Name & Degree

Sirentra Wanglikitkoon, MD

First Name & Middle Initial & Last Name & Degree

Somkit Penpattanagul, MD

12. IPD Sharing Statement

Citations:

PubMed Identifier

31074236

Citation

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.

Results Reference

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Adjuvant Chemotherapy for Locally Advanced Cervical Cancer

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