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Cervical CancerPhase 3NACOPRADNCT02422563

NeoAdjuvant Chemotherapy Followed by Radical Hysterectomy (OP) Versus Primary Chemo-RADiation in Cervical Cancer FIGO Stage IB2 and IIB

A Phase 3 study testing hysterectomy, Radiation and Cisplatin in people with Cervical Cancer, run by Charite University, Berlin, Germany.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

Randomized comparison of neoadjuvant chemotherapy followed by radical hysterectomy with pelvic ± para-aortic lymphonodectomy (LNE) versus primary cisplatin-based chemo-radiation in patients with cervical cancer FIGO IB2 and IIB. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Cervical Cancer
What is being tested?
hysterectomy, Radiation and Cisplatin
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
534 participants
Where
No sites listed yet
Study dates
Oct 2015to Oct 2025
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 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • >18 years
  • cervical cancer FIGO IB2, IIB,
  • squamous cell, adeno or adenosquamous cell carcinoma
  • informed consent

Who cannot join

  • small cell/neuroendocrine component
  • previous radiation, previous cancer
  • pregnancy
  • HIV
  • severe co-morbidities

Trial locations and contacts

No sites are listed yet.

Simone Marnitz, MD contact

simone.marnitz@charite.de

About this study

Official title: Multicenter Prospective Randomized Study on NeoAdjuvant Chemotherapy Followed by Radical Hysterectomy (OP) Versus Primary Chemo-RADiation in Patients With Cervical Cancer FIGO Stage IB2 and IIB

Randomized comparison of neoadjuvant chemotherapy followed by radical hysterectomy with pelvic ± para-aortic lymphonodectomy (LNE) versus primary cisplatin-based chemo-radiation in patients with cervical cancer FIGO IB2 and IIB.

Read the detailed description

The optimal treatment for patients with cervical cancer on FIGO stage IB2 and IIB is controversial. There is no randomized comparison of a dose-dense NACT (TP or TIP-schedule) followed by hysterectomy and LNE (investigational Arm A) versus primary chemo-radiation (standard arm B). Primary endpoint is the DFS at 5 years, secondary endpoints local control at 5 years, OS at 5 years, QOL, questionnaires on sexual activity/QOL.

Conditions
Cervical Cancer
Being tested
hysterectomy, Radiation, Cisplatin, Paclitaxel, Carboplatin
Keywords
neoadjuvant chemotherapy, FIGO IB2, FIGO IIB, chemo-radiation, dose dense chemotherapy, cisplatin, paclitaxel, carboplatin, ifosfamide
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.

Study groups in NCT02422563
Study groupRoleWhat they receive
Arm A: NACT+radical hysterectomyExperimentalArm A includes patients for dose dense chemotherapy using TP (paclitaxel, carboplatin) or TIP (cisplatin, paclitaxel, ifosfamide) weekly for six cycles. Radical hysterectomy is performed after the 6th week + lymphadenectomy
Receives: Procedure: hysterectomy; Drug: Cisplatin; Drug: Paclitaxel; Drug: Carboplatin; Drug: Ifosfamide
Arm B: ChemoradiationOtherArm B includes patients undergoing primary cisplatin based chemo-radiation
Receives: Radiation: Radiation; Drug: Cisplatin

What is being measured

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

  1. disease free survival

    DFS

    Measured: 5 years

Secondary outcomes (3)

  1. overall survival

    Measured: 5 years

  2. local control

    local control rate at 5 years

    Measured: 5 years

  3. quality of life

    Qol questionnaire EORTC Qol C30 and Cervical Cancer Module EORTC QLQ-CX24

    Measured: 5 years

Timeline

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

  1. First posted21 Apr 2015 (estimated)
  2. Study startOct 2015
  3. Primary completionOct 2020 (estimated)
  4. Study completionOct 2025 (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
None (open label)
Enrolment
534 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02422563
Sponsor's protocol ID
NACOPRAD_2015
Acronym
NACOPRAD
Status last verified
Apr 2015
First submitted
11 Feb 2015
Last updated
21 Apr 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • Sardi JE, di Paola GR, Cachau A, Ortiz OC, Sananes C, Giaroli A, Martins D, Peluffo M. A possible new trend in the management of the carcinoma of the cervix uteri. Gynecol Oncol. 1986 Oct;25(2):139-49. doi: 10.1016/0090-8258(86)90095-8.

    PubMed 2428700

  • Benedetti-Panici P, Greggi S, Colombo A, Amoroso M, Smaniotto D, Giannarelli D, Amunni G, Raspagliesi F, Zola P, Mangioni C, Landoni F. Neoadjuvant chemotherapy and radical surgery versus exclusive radiotherapy in locally advanced squamous cell cervical cancer: results from the Italian multicenter randomized study. J Clin Oncol. 2002 Jan 1;20(1):179-88. doi: 10.1200/JCO.2002.20.1.179.

    PubMed 11773168

  • Sardi J, Sananes C, Giaroli A, Maya G, di Paola G. Neoadjuvant chemotherapy in locally advanced carcinoma of the cervix uteri. Gynecol Oncol. 1990 Sep;38(3):486-93. doi: 10.1016/0090-8258(90)90096-4.

    PubMed 1699851

  • Souhami L, Gil RA, Allan SE, Canary PC, Araujo CM, Pinto LH, Silveira TR. A randomized trial of chemotherapy followed by pelvic radiation therapy in stage IIIB carcinoma of the cervix. J Clin Oncol. 1991 Jun;9(6):970-7. doi: 10.1200/JCO.1991.9.6.970.

    PubMed 1709686

  • Gadducci A, Sartori E, Maggino T, Zola P, Cosio S, Zizioli V, Lapresa M, Piovano E, Landoni F. Pathological response on surgical samples is an independent prognostic variable for patients with Stage Ib2-IIb cervical cancer treated with neoadjuvant chemotherapy and radical hysterectomy: an Italian multicenter retrospective study (CTF Study). Gynecol Oncol. 2013 Dec;131(3):640-4. doi: 10.1016/j.ygyno.2013.09.029. Epub 2013 Oct 3.

    PubMed 24096111

  • Lissoni AA, Colombo N, Pellegrino A, Parma G, Zola P, Katsaros D, Chiari S, Buda A, Landoni F, Peiretti M, Dell'anna T, Fruscio R, Signorelli M, Grassi R, Floriani I, Fossati R, Torri V, Rulli E. A phase II, randomized trial of neo-adjuvant chemotherapy comparing a three-drug combination of paclitaxel, ifosfamide, and cisplatin (TIP) versus paclitaxel and cisplatin (TP) followed by radical surgery in patients with locally advanced squamous cell cervical carcinoma: the Snap-02 Italian Collaborative Study. Ann Oncol. 2009 Apr;20(4):660-5. doi: 10.1093/annonc/mdn690. Epub 2009 Jan 30.

    PubMed 19181826

  • Buda A, Fossati R, Colombo N, Fei F, Floriani I, Gueli Alletti D, Katsaros D, Landoni F, Lissoni A, Malzoni C, Sartori E, Scollo P, Torri V, Zola P, Mangioni C. Randomized trial of neoadjuvant chemotherapy comparing paclitaxel, ifosfamide, and cisplatin with ifosfamide and cisplatin followed by radical surgery in patients with locally advanced squamous cell cervical carcinoma: the SNAP01 (Studio Neo-Adjuvante Portio) Italian Collaborative Study. J Clin Oncol. 2005 Jun 20;23(18):4137-45. doi: 10.1200/JCO.2005.04.172.

    PubMed 15961761

  • Landoni F, Sartori E, Maggino T, Zola P, Zanagnolo V, Cosio S, Ferrari F, Piovano E, Gadducci A. Is there a role for postoperative treatment in patients with stage Ib2-IIb cervical cancer treated with neo-adjuvant chemotherapy and radical surgery? An Italian multicenter retrospective study. Gynecol Oncol. 2014 Mar;132(3):611-7. doi: 10.1016/j.ygyno.2013.12.010. Epub 2013 Dec 14.

    PubMed 24342439

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing hysterectomy, Radiation and Cisplatin in people with Cervical Cancer, run by Charite University, Berlin, Germany.

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 4 inclusion and 5 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 21 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.

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 Simone Marnitz, MD (simone.marnitz@charite.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

disease free survival (time frame: 5 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 NCT02422563, which also lists 8 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 21 Apr 2015.

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