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Cervical CancerNCT02642471

Sentinel Lymph Node Biopsy Versus Pelvic Lymphadenectomy in Early-stage Cervical Cancer (PHENIX/CSEM 010)

A study testing no systematic pelvic lymphadenectomy in people with Cervical Cancer and Surgery, run by Sun Yat-sen University at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The diagnostic value of sentinel lymph node biopsy in early-stage cervical cancer has been well studied. However, there were no randomized controlled study on comparing the long-term outcomes of sentinel lymph node biopsy and conventional procedure. Read more about this study

Who is it for?
Ages 18 to 65 years, women only
Conditions the study is for
Cervical Cancer, Surgery, Quality of Life
What is being tested?
no systematic pelvic lymphadenectomy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,080 participants
Where
1 siteChina
Study dates
31 Dec 2015to 31 Dec 2024
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 65 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with newly histologically confirmed cervical carcinoma
  • Histopathology squamous carcinoma, adenocarcinoma or adeno-squamous carcinoma
  • Original clinical stage must be FIGO (2018) stage IA1 (lymphovascular space involvement), IA2, IB1, IB2 and IIA1
  • No suspected node should be found on imaging examination (RESIST 1.1)
  • Age between 18-65
  • Patients must give signed informed consent
Show all 9Show fewer
  • P.S status: 0-1
  • Estimated survival time > 3 months
  • Tumor diameter ≤ 3 cm

Who cannot join

  • The presence of uncontrolled life-threatening illness
  • Receiving other ways of anti-cancer therapy
  • Investigator consider the patients can't finish the whole study
  • With normal liver function test (ALT、AST>2.5×ULN)
  • With normal renal function test (Creatinine>1.5×ULN)
  • WBC<4,000/mm3 or PLT<100,000/mm
Show all 10Show fewer
  • The whole cervix has been occupied by tumor and there is no normal surface left for tracer injection
  • History of severe heart disease or deep venous thrombosis; 4) Presence or history of other malignant disease
  • Gestation or perinatal period
  • Intention to fertility preservation.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Department of Gynecologic Oncology, Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510060

Other trials in China

About this study

The diagnostic value of sentinel lymph node biopsy in early-stage cervical cancer has been well studied. However, there were no randomized controlled study on comparing the long-term outcomes of sentinel lymph node biopsy and conventional procedure. The investigators perform a phase III, randomized controlled trial to determine whether pelvic lymphadenectomy can be replaced by sentinel lymph node biopsy in surgical treatment for patients with early-stage cervical cancer.

Read the detailed description

This study comprises two parts: PHENIX-I: To compare the outcomes of managements with and without pelvic lymphadenectomy for patients with negative sentinel lymph node; PHENIX-II: To compare the outcomes of managements with and without pelvic lymphadenectomy for patients with positive sentinel lymph node. Patients with newly diagnosed International Federation of Gynecology and Obstetrics (FIGO) stage IA1 (lymphovascular space involvement), IA2, IB1, and IB2 cervical cancer are eligible for our study. The tumor diameter should be less than 3cm. Sentinel lymph node biopsy will be performed at the beginning of operations. After pathological examination of frozen section, patients will be assigned to PHENIX-I or PHENIX-II study according to their status of sentinel nodes. In both parts of this trail, patients have equal chance to be randomly assigned to experimental arms (radical hysterectomy only) and reference arms (radical hysterectomy and pelvic lymphadenectomy).Adjuvant treatments will be planned according to postoperative pathological factors. The primary objective is disease-free survival at 3 years for PHENIX-I and 2 years for PHENIX-II. The secondary end points are overall survival, long-term outcome of sentinel lymph node biopsy and the quality of life.

Being tested
no systematic pelvic lymphadenectomy
Keywords
sentinel lymph node, pelvic lymphadenectomy, cervical carcinoma, surgery, radiotherapy
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.

  • no systematic pelvic lymphadenectomyProcedure or surgery

    systematic pelvic lymphadenectomy is omitted in surgical treatment

Study groups in NCT02642471
Study groupRoleWhat they receive
Arm 1Experimentalpatients with negative sentinel nodes confirmed by pathological examination of frozen section will be randomly assigned to Arm 1 or Arm 2 Arm 1: patients undergo radical hysterectomy±salpingo-oophorectomy (no systematic pelvic lymphadenectomy) Arm 2: patients undergo radical hysterectomy±salpingo-oophorectomy+pelvic lymph node dissection
Receives: Procedure: no systematic pelvic lymphadenectomy
Arm 2No interventionpatients with negative sentinel nodes confirmed by pathological examination of frozen section will be randomly assigned to Arm 1 or Arm 2 Arm 1: patients undergo radical hysterectomy±salpingo-oophorectomy (no systematic pelvic lymphadenectomy) Arm 2: patients undergo radical hysterectomy±salpingo-oophorectomy+pelvic lymph node dissection
Arm 3Experimentalpatients with positive sentinel nodes confirmed by pathological examination of frozen section will be randomly assigned to Arm 3 or Arm 4 Arm 3: patients undergo radical hysterectomy±salpingo-oophorectomy (no systematic pelvic lymphadenectomy) Arm 4: patients undergo radical hysterectomy±salpingo-oophorectomy+pelvic lymph node dissection
Receives: Procedure: no systematic pelvic lymphadenectomy
Arm 4No interventionpatients with positive sentinel nodes confirmed by pathological examination of frozen section will be randomly assigned to Arm 3 or Arm 4 Arm 3: patients undergo radical hysterectomy±salpingo-oophorectomy (no systematic pelvic lymphadenectomy) Arm 4: patients undergo radical hysterectomy±salpingo-oophorectomy+pelvic lymph node dissection

What is being measured

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

  1. Disease free survival in PHENIX-I

    Measured: 3 years

  2. Disease free survival in PHENIX-II

    Measured: 2 years

Secondary outcomes (7)

  1. Surgical morbidity

    Measured: 3 years

  2. Rate of retroperitoneal node recurrence

    Measured: 3 years

  3. Overall survival

    Measured: 5 years

  4. Patients' quality of life

    Measured: 5 years

  5. Performance of SLN detection

    Measured: 3 years

  6. Diagnostic accuracy of frozen section examination

    Measured: 3 years

  7. Anatomic distribution of SLNs

    Measured: 3 years

Timeline

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

  1. First posted30 Dec 2015 (estimated)
  2. Study start31 Dec 2015
  3. Primary completion31 Dec 2024 (estimated)
  4. Study completion31 Dec 2024 (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
1,080 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02642471
Sponsor's protocol ID
2015-FXY-073
Status last verified
Dec 2024
First submitted
24 Dec 2015
Last updated
16 Dec 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Tu H, Huang H, Li Y, Chen X, Wang C, Zheng M, Zhang Y, Zhao W, Feng Y, Wan T, Huang Y, Yu A, Lu W, Xiao J, Shan W, Zhang P, Zhu C, Wang D, Zhou H, Li J, Kong B, Feng W, Wang X, Luo R, Huang X, Li J, Lin Z, Yao S, Liu J; PHENIX Investigators. Sentinel-Lymph-Node Biopsy Alone or with Lymphadenectomy in Cervical Cancer. N Engl J Med. 2025 Oct 16;393(15):1463-1474. doi: 10.1056/NEJMoa2506267.

    PubMed 41092328

  • Tu H, Huang H, Xian B, Li J, Wang P, Zhao W, Chen X, Xie X, Wang C, Kong B, Xiao J, Zhang P, Liu J; PHENIX Investigators and the CSEM group. Sentinel lymph node biopsy versus pelvic lymphadenectomy in early-stage cervical cancer: a multi-center randomized trial (PHENIX/CSEM 010). Int J Gynecol Cancer. 2020 Nov;30(11):1829-1833. doi: 10.1136/ijgc-2020-001857. Epub 2020 Sep 24.

    PubMed 32973117

Questions about this trial

What is this clinical trial studying?

A study testing no systematic pelvic lymphadenectomy in people with Cervical Cancer and Surgery, run by Sun Yat-sen University 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 9 inclusion and 10 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: under way, not looking for participants, as of the sponsor's last update on 16 Dec 2024. 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease free survival in PHENIX-I (time frame: 3 years). The study lists 2 primary outcomes in all. 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 NCT02642471, which also lists 2 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 16 Dec 2024.

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