The Efficacy of Adjuvant Chemotherapy in Locally Advanced Cervical Cancer

NCT04409860 | Recruiting

• 1 other identifier: CQGOG0102
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this trial was to evaluate the efficacy of adjuvant chemotherapy in the locally advanced cervical cancer with residual lesions after concurrent chemoradiation therapy.

Conditions

Cervical Cancer

Keywords

Locally adcanced; CCRT; Adjuvant chemotherapy

Outcome Measures

Primary Outcomes (1)

• PFS

  Progression-free survival

  2 years

Secondary Outcomes (2)

• OS

  5 years

• ORR

  3 months

Study Arms (2)

control group

ACTIVE COMPARATOR

In this group, observation is given after CCRT.

Radiation: CCRT

trial group

EXPERIMENTAL

In this group, adjuvant chemotherapy is given after CCRT.

Radiation: CCRT; Drug: Paclitaxel, Cisplatin

Interventions

CCRT RADIATION

Radiation concurrent platinum-containing chemotherapy (cisplatin or carboplatin)

Also known as: control group: CCRT + observation

control group; trial group

Paclitaxel, Cisplatin DRUG

The regimen of adjuvant chemotherapy following CCRT is Paclitaxel(150mg/m2 D1), Cisplatin(60mg/m2 D1) , q3w, three cycles.

Also known as: trial group: CCRT + adjuvant chemotherapy

trial group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Cervical cancer stage IIb to IVa with histopathology of squamous cell carcinoma, adenosquamous cell carcinoma, adenocarcinoma
• Complete CCRT(Radiation Does: A point 85Gy(+/-10%)，B点50Gy(+/-10%)，concurrent platinum-containing chemotherapy (cisplatin or carboplatin))
• MRI is performed within 4 weeks after CCRT and shows residual lesions (non-lymph node≥10mm, lymph node shortest diameter≥15mm).
• ECOG\<2
• Expected survival is longer than six months
• Hb≥70g/L、WBC≥3.5×109/ L 、ANC≥1.5×109/L、PLT≥80×109/L
• ALT and AST≤2×ULN, Serum creatinine≤1.5×ULN
• The serum or urine pregnancy test must be negative within 7 days before enrollment for the women of childbearing age who should agree that contraception must be used during the trial

You may not qualify if:

• Activity or uncontrol severe infection
• Liver cirrhosis, Decompensated liver disease
• History of immune deficiency, including HIV positive or suffering from congenital immunodeficiency disease
• Patients who cannot tolerate chemotherapy because of chronic renal insufficiency or renal failure
• Have suffered or combined with other malignant tumor
• Myocardial infarction, severe arrhythmia and NYHA (New York heart association)≥2 for congestive heart failure
• A history targeted therapy or pelvic artery embolization
• Artery-enous thrombosis within 6 months
• Patients with autoimmune diseases
• Complications, need to be treatment with drugs which may lead to liver or kidney injury
• Patients with disease progression after chemoradiation

Sponsors & Collaborators

• Chongqing University Cancer Hospital: lead

Study Sites (1)

Chongqing Cancer Hospital

Chongqing, Chongqing Municipality, 400030, China

RECRUITING

Related Publications (19)

• de Sanjose S, Serrano B, Castellsague X, Brotons M, Munoz J, Bruni L, Bosch FX. Human papillomavirus (HPV) and related cancers in the Global Alliance for Vaccines and Immunization (GAVI) countries. A WHO/ICO HPV Information Centre Report. Vaccine. 2012 Nov 20;30 Suppl 4:D1-83, vi. doi: 10.1016/S0264-410X(12)01435-1. No abstract available.

  PMID: 23510764 BACKGROUND

• Verma J, Monk BJ, Wolfson AH. New Strategies for Multimodality Therapy in Treating Locally Advanced Cervix Cancer. Semin Radiat Oncol. 2016 Oct;26(4):344-8. doi: 10.1016/j.semradonc.2016.05.003. Epub 2016 May 26.

  PMID: 27619255 BACKGROUND

• Rose PG. Chemoradiotherapy for cervical cancer. Eur J Cancer. 2002 Jan;38(2):270-8. doi: 10.1016/s0959-8049(01)00352-5.

  PMID: 11803143 BACKGROUND

• Chemoradiotherapy for Cervical Cancer Meta-Analysis Collaboration. Reducing uncertainties about the effects of chemoradiotherapy for cervical cancer: a systematic review and meta-analysis of individual patient data from 18 randomized trials. J Clin Oncol. 2008 Dec 10;26(35):5802-12. doi: 10.1200/JCO.2008.16.4368. Epub 2008 Nov 10.

  PMID: 19001332 BACKGROUND

• Chereau E, DE LA Hosseraye C, Ballester M, Monnier L, Rouzier R, Touboul E, Darai E. The role of completion surgery after concurrent radiochemotherapy in locally advanced stages IB2-IIB cervical cancer. Anticancer Res. 2013 Apr;33(4):1661-6.

  PMID: 23564812 BACKGROUND

• Carcopino X, Houvenaeghel G, Buttarelli M, Esterni B, Tallet A, Goncalves A, Jacquemier J. Equivalent survival in patients with advanced stage IB-II and III-IVA cervical cancer treated by adjuvant surgery following chemoradiotherapy. Eur J Surg Oncol. 2008 May;34(5):569-75. doi: 10.1016/j.ejso.2007.04.006. Epub 2007 May 25.

  PMID: 17531428 BACKGROUND

• Hequet D, Marchand E, Place V, Fourchotte V, De La Rochefordiere A, Dridi S, Coutant C, Lecuru F, Bats AS, Koskas M, Bretel JJ, Bricou A, Delpech Y, Barranger E. Evaluation and impact of residual disease in locally advanced cervical cancer after concurrent chemoradiation therapy: results of a multicenter study. Eur J Surg Oncol. 2013 Dec;39(12):1428-34. doi: 10.1016/j.ejso.2013.10.006. Epub 2013 Oct 23.

  PMID: 24183796 BACKGROUND

• Ferrandina G, Margariti PA, Smaniotto D, Petrillo M, Salerno MG, Fagotti A, Macchia G, Morganti AG, Cellini N, Scambia G. Long-term analysis of clinical outcome and complications in locally advanced cervical cancer patients administered concomitant chemoradiation followed by radical surgery. Gynecol Oncol. 2010 Dec;119(3):404-10. doi: 10.1016/j.ygyno.2010.08.004.

  PMID: 20817228 BACKGROUND

• Colombo PE, Bertrand MM, Gutowski M, Mourregot A, Fabbro M, Saint-Aubert B, Quenet F, Gourgou S, Kerr C, Rouanet P. Total laparoscopic radical hysterectomy for locally advanced cervical carcinoma (stages IIB, IIA and bulky stages IB) after concurrent chemoradiation therapy: surgical morbidity and oncological results. Gynecol Oncol. 2009 Sep;114(3):404-9. doi: 10.1016/j.ygyno.2009.05.043. Epub 2009 Jun 24.

  PMID: 19555996 BACKGROUND

• Houvenaeghel G, Lelievre L, Rigouard AL, Buttarelli M, Jacquemier J, Viens P, Gonzague-Casabianca L. Residual pelvic lymph node involvement after concomitant chemoradiation for locally advanced cervical cancer. Gynecol Oncol. 2006 Jul;102(1):74-9. doi: 10.1016/j.ygyno.2005.11.037. Epub 2006 Jan 10.

  PMID: 16406062 BACKGROUND

• Houvenaeghel G, Lelievre L, Buttarelli M, Jacquemier J, Carcopino X, Viens P, Gonzague-Casabianca L. Contribution of surgery in patients with bulky residual disease after chemoradiation for advanced cervical carcinoma. Eur J Surg Oncol. 2007 May;33(4):498-503. doi: 10.1016/j.ejso.2006.10.011. Epub 2006 Dec 6.

  PMID: 17156969 BACKGROUND

• Vrdoljak E, Omrcen T, Novakovic ZS, Jelavic TB, Prskalo T, Hrepic D, Hamm W. Concomitant chemobrachyradiotherapy with ifosfamide and cisplatin followed by consolidation chemotherapy for women with locally advanced carcinoma of the uterine cervix--final results of a prospective phase II-study. Gynecol Oncol. 2006 Nov;103(2):494-9. doi: 10.1016/j.ygyno.2006.03.060. Epub 2006 Jun 30.

  PMID: 16814371 BACKGROUND

• Domingo E, Lorvidhaya V, de Los Reyes R, Syortin T, Kamnerdsupaphon P, Lertbutsayanukul C, Vito-Cruz E, Tharavichitkul E, Jin K, Yoshihara M, Cupino N, Lertsanguansinchai P. Capecitabine-based chemoradiotherapy with adjuvant capecitabine for locally advanced squamous carcinoma of the uterine cervix: phase II results. Oncologist. 2009 Aug;14(8):828-34. doi: 10.1634/theoncologist.2009-0041. Epub 2009 Aug 6.

  PMID: 19661184 BACKGROUND

• Choi CH, Lee YY, Kim MK, Kim TJ, Lee JW, Nam HR, Huh SJ, Lee JH, Bae DS, Kim BG. A matched-case comparison to explore the role of consolidation chemotherapy after concurrent chemoradiation in cervical cancer. Int J Radiat Oncol Biol Phys. 2011 Dec 1;81(5):1252-7. doi: 10.1016/j.ijrobp.2010.07.2006. Epub 2010 Nov 13.

  PMID: 21075554 BACKGROUND

• Zhang MQ, Liu SP, Wang XE. Concurrent chemoradiotherapy with paclitaxel and nedaplatin followed by consolidation chemotherapy in locally advanced squamous cell carcinoma of the uterine cervix: preliminary results of a phase II study. Int J Radiat Oncol Biol Phys. 2010 Nov 1;78(3):821-7. doi: 10.1016/j.ijrobp.2009.08.069. Epub 2010 Mar 6.

  PMID: 20207507 BACKGROUND

• Duenas-Gonzalez A, Zarba JJ, Patel F, Alcedo JC, Beslija S, Casanova L, Pattaranutaporn P, Hameed S, Blair JM, Barraclough H, Orlando M. Phase III, open-label, randomized study comparing concurrent gemcitabine plus cisplatin and radiation followed by adjuvant gemcitabine and cisplatin versus concurrent cisplatin and radiation in patients with stage IIB to IVA carcinoma of the cervix. J Clin Oncol. 2011 May 1;29(13):1678-85. doi: 10.1200/JCO.2009.25.9663. Epub 2011 Mar 28.

  PMID: 21444871 BACKGROUND

• Tang J, Tang Y, Yang J, Huang S. Chemoradiation and adjuvant chemotherapy in advanced cervical adenocarcinoma. Gynecol Oncol. 2012 May;125(2):297-302. doi: 10.1016/j.ygyno.2012.01.033. Epub 2012 Jan 31.

  PMID: 22307061 BACKGROUND

• Lorvidhaya V, Chitapanarux I, Sangruchi S, Lertsanguansinchai P, Kongthanarat Y, Tangkaratt S, Visetsiri E. Concurrent mitomycin C, 5-fluorouracil, and radiotherapy in the treatment of locally advanced carcinoma of the cervix: a randomized trial. Int J Radiat Oncol Biol Phys. 2003 Apr 1;55(5):1226-32. doi: 10.1016/s0360-3016(02)04405-x.

  PMID: 12654431 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Observation; TP protocol; Chemotherapy, Adjuvant

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)

Methods; Investigative Techniques; Combined Modality Therapy; Therapeutics; Drug Therapy

Study Officials

• Dongling Zou, M.D.

  Chongqing University Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dongling Zou, M.D.

CONTACT

13657690699; cqzl_zdl@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated Director

Study Record Dates

• First Submitted: May 23, 2020
• First Posted: June 1, 2020
• Study Start: May 26, 2020
• Primary Completion: April 1, 2024
• Study Completion (Estimated): April 1, 2029
• Last Updated: April 11, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)