Adjuvant Chemotherapy for Locally Advanced Cervical Cancer

NCT02036164 | Unknown Phase 3 DMC

• 2 other identifiers: COA-CREC 002/201320140106001
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 11

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.

Conditions

Uterine Cervical Cancer

Keywords

Locally advanced cervical cancer; Concurrent chemoradiation; Adjuvant chemotherapy

Outcome Measures

Primary Outcomes (1)

• Progression-free survival

  3-year progression free survival

  3 years

Secondary Outcomes (1)

• Overall survival

  3 years

Other Outcomes (3)

• Response rate

  4 months after completion of CCRT

• 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

• Adverse event

  up to 6 months after treatment

Study Arms (2)

Concurrent chemoradiation

ACTIVE COMPARATOR

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; Drug: Cisplatin

Concurretn chemoradiation plus adjuvant chemotherapy

EXPERIMENTAL

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; Drug: Cisplatin; Drug: Paclitaxel; Drug: Carboplatin

Interventions

Pelvic radiation RADIATION

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

Also known as: External beam pelvic radiation therapy and brachytherapy

Concurrent chemoradiation; Concurretn chemoradiation plus adjuvant chemotherapy

Cisplatin DRUG

Cisplatin 40 mg/m2 i.v.

Also known as: Drugs:, - Cisplatin, - Kemoplat®, - Platin®

Concurrent chemoradiation; Concurretn chemoradiation plus adjuvant chemotherapy

Paclitaxel DRUG

Paclitaxel 175 mg m2 i.v.

Also known as: - Intaxel®, - Anzatax®

Concurretn chemoradiation plus adjuvant chemotherapy

Carboplatin DRUG

Carboplatin AUC 5 i.v.

Also known as: - Carboplatin®, - Kemocarb®

Concurretn chemoradiation plus adjuvant chemotherapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Siriwan Tangjitgamol, MD: lead
• National Research Council of Thailand: collaborator
• Navamindradhiraj University: collaborator
• Chiang Mai University: collaborator
• Prince of Songkla University: collaborator
• Bhumibol Adulyadej Hospital: collaborator
• Lopburi Cancer Hospital: collaborator
• Ubonratchathani Cancer Hospital: collaborator
• Udonthani Cancer Hospital: collaborator
• Chonburi Cancer Hospital: collaborator
• Lampang Cancer Hospital: collaborator
• Health Intervention and Technology Assessment Program: collaborator
• Rajburi Hospital: collaborator

Study Sites (11)

Bhumibol Adulyadej Hospital

Bangkok, Bangkok, 10220, Thailand

RECRUITING

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

Bangkok, Bangkok, 10300, Thailand

RECRUITING

Health Intervention and Technology Assessment Program

Bangkok, Bangkok, 11000, Thailand

NOT YET RECRUITING

Chonburi Cancer Hospital

Chon Buri, Changwat Chon Buri, 20000, Thailand

RECRUITING

Lampang Cancer Hospital

Lampang, Changwat Lampang, 52000, Thailand

RECRUITING

Lopburi Cancer Hospital

Lopburi, Changwat Lop Buri, 15000, Thailand

RECRUITING

Ratchaburi Hospital

Muang, Changwat Ratchaburi, 70000, Thailand

ACTIVE NOT RECRUITING

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

Songkhla, Changwat Songkhla, 90110, Thailand

RECRUITING

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

Chiang Mai, Chiang Mai, 50200, Thailand

RECRUITING

Ubonratchathani Cancer Hospital

Ubonratchathani, Ubonratchathani, 34000, Thailand

RECRUITING

Udonthani Cancer Hopital

Udon Thani, Udonthani, 41330, Thailand

RECRUITING

Related Publications (1)

• 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.

  PMID: 31074236 DERIVED

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Brachytherapy; Cisplatin; Pharmaceutical Preparations; Paclitaxel; Carboplatin

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Coordination Complexes

Study Officials

• Siriwan Tangjitgamol, MD

  Navamindradhiraj University

  PRINCIPAL INVESTIGATOR

• Vichan Lordvithaya, MD

  Chiang Mai University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Siriwan Tangjitgamol, MD

CONTACT

66-86-3841431; siriwanonco@yahoo.com

Vichan Lordvithaya, MD

CONTACT

6681-6814367; vilorvid@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: January 8, 2014
• First Posted: January 14, 2014
• Study Start: January 1, 2014
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2019
• Last Updated: April 6, 2017

Record last verified: 2017-04

Locations

TH (11)