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AzTrials

Cervical CancerCQGOG0102NCT04409860

The Efficacy of Adjuvant Chemotherapy in Locally Advanced Cervical Cancer

A study testing CCRT and Paclitaxel, Cisplatin in people with Cervical Cancer, run by Chongqing University Cancer Hospital at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years, women only
Conditions the study is for
Cervical Cancer
What is being tested?
CCRT and Paclitaxel, Cisplatin
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteChina
Study dates
26 May 2020to Apr 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

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 75 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Dongling Zou, M.D. contact

13657690699

cqzl_zdl@163.com

China1 site, 1 recruiting
  • Chongqing Cancer Hospital

    Chongqing, Chongqing Municipality, 400030

    Dongling Zou, M.D., 13657690699, cqzl_zdl@163.com

    Dongling Zou, M.D.

    Recruiting

Other trials in China

About this study

Official title: Randomized Controlled Trial of the Efficacy of Adjuvant Chemotherapy in Patients With Residual Lesions After Concurrent Radiochemotherapy for Locally Advanced Cervical Cancer

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.

Read the detailed description
  1. Objective: To compare response rate and survivals of locally advanced stage cervical cancer patients with residual lesions who had CCRT alone to those who had adjuvant chemotherapy after CCRT.
  2. Patients:
  3. Cervical cancer stage IIb to IVa with histopathology of squamous cell carcinoma, adenosquamous cell carcinoma, adenocarcinoma
  4. Complete CCRT(Radiation Does: A point 85Gy(+/-10%), B点50Gy(+/-10%), concurrent platinum-containing chemotherapy(cisplatin or carboplatin)
  5. MRI is performed within 4 weeks after CCRT and shows residual lesions (non-lymph node≥10mm, lymph node shortest diameter≥15mm).
  6. Methods:

The patients who have residual lesions after CCRT are randomized to arm A by observation or arm B by adjuvant chemotherapy with paclitaxel plus cisplatin every 3 weeks for 3 cycles.

Conditions
Cervical Cancer
Being tested
CCRT, Paclitaxel, Cisplatin
Keywords
Locally adcanced, CCRT, 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.

  • CCRTRadiation

    Also called control group: CCRT + observation

    Radiation concurrent platinum-containing chemotherapy (cisplatin or carboplatin)

  • Paclitaxel, CisplatinDrug

    Also called trial group: CCRT + adjuvant chemotherapy

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

Study groups in NCT04409860
Study groupRoleWhat they receive
control groupActive comparatorIn this group, observation is given after CCRT.
Receives: Radiation: CCRT
trial groupExperimentalIn this group, adjuvant chemotherapy is given after CCRT.
Receives: Radiation: CCRT; Drug: Paclitaxel, Cisplatin

What is being measured

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

  1. PFS

    Progression-free survival

    Measured: 2 years

Secondary outcomes (2)
  1. OS

    5 years overall survival

    Measured: 5 years

  2. ORR

    To evaluate the objective response rate(CR+PR) of adjuvant chemotherapy in cervical cancer

    Measured: 3 months

Timeline

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

  1. First posted1 Jun 2020
  2. Study start26 May 2020
  3. Primary completionApr 2024 (estimated)
  4. Study completionApr 2029 (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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04409860
Sponsor's protocol ID
CQGOG0102
Acronym
CQGOG0102
Status last verified
Apr 2023
First submitted
23 May 2020
Last updated
11 Apr 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 23510764
  • 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.

    PubMed 27619255
  • Rose PG. Chemoradiotherapy for cervical cancer. Eur J Cancer. 2002 Jan;38(2):270-8. doi: 10.1016/s0959-8049(01)00352-5.

    PubMed 11803143
  • 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.

    PubMed 19001332
  • 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.

    PubMed 23564812
  • 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.

    PubMed 17531428
  • 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.

    PubMed 24183796
  • 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.

    PubMed 20817228
  • 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.

    PubMed 19555996
  • 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.

    PubMed 16406062
  • 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.

    PubMed 17156969
  • 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.

    PubMed 16814371
  • 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.

    PubMed 19661184
  • 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.

    PubMed 21075554
  • 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.

    PubMed 20207507

Questions about this trial

What is this clinical trial studying?

A study testing CCRT and Paclitaxel, Cisplatin in people with Cervical Cancer, run by Chongqing University Cancer Hospital at 1 site in China.

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 11 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: looking for participants now, as of the sponsor's last update on 11 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. 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.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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

Contact Dongling Zou, M.D. (13657690699, cqzl_zdl@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PFS (time frame: 2 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 NCT04409860, which also lists 19 linked publications.

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 11 Apr 2023.

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