AzTrials
AzTrials

Uterine Cervical NeoplasmsPhase 3NCT03955367

Pelvic RT Versus Prophylactic Extended-field RT in Patients With Cervical Cancer

A Phase 3 study testing Prophylactic extended-field Irradiation, Pelvic irradiation and Intracavitary brachytherapy in people with Uterine Cervical Neoplasms, run by Peking Union Medical College Hospital at 2 sites in China.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

Trial summary

To investigate the value of prophylactic extended-field irradiation (EFI), we conduct a randomized clinical trial to compare the efficacy and toxicity of pelvic irradiation and prophylactic EFI in selected patients with cervical cancer treated with definitive concurrent chemoradiotherapy. Read more about this study

Who is it for?
Ages 18 to 70 years, women only
Conditions the study is for
Uterine Cervical Neoplasms
What is being tested?
Prophylactic extended-field Irradiation, Pelvic irradiation and Intracavitary brachytherapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
638 participants
Where
2 sitesChina
Study dates
17 Jun 2019to 1 Jun 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 to 70 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must be informed of the investigational nature of this study and give written informed consent with 30 days before treatment.
  • Age ≥18 years and ≤ 70 years.
  • Patients with newly histologically confirmed cervical cancer, including squamous cell carcinoma, adenocarcinoma and adenosquamous carcinoma, et al.
  • No evidence of para-aortic metastatic lymph nodes (MLNs) on CT, MRI or positron emission tomograph (PET)/CT.*
  • No evidence of distant metastasis (FIGO stage IVB).
  • At least meet one of the following characteristics:
Show all 14Show fewer
  • Number of pelvic MLNs ≥ 2;
  • Short diameter of pelvic MLNs ≥ 1.5cm; *
  • Parametrial involvement to the pelvic wall ＃.
  • Satisfactory performance: Eastern Cooperative Oncology Group (ECOG) score ≥ 2.
  • Adequate marrow: neutrophile granulocyte count ≥1.5*10^9/L, hemoglobin ≥ 80 g/L, platelet count ≥100*10^9/L.
  • Normal liver and kidney function: Creatinine (Cr) < 1.5 mg/dl, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) < 2*upper limit of normal (ULN).
  • MLNs refer to positive lymph nodes confirmed by PET/CT or lymph nodes with short diameter ≥ 1 cm on CT or MRI.
  • Parametrial involvement to the pelvic wall is diagnosed with gynecological examination or MRI;

Who cannot join

  • With common iliac MLNs.
  • Tumor extended to the lower third of the vagina.
  • Tumor spread to mucosa of the bladder or rectum.
  • Prior surgery (including pelvic or para-aortic lymph nodes resection, except for tumor biopsy), radiotherapy or chemotherapy to primary tumor or nodes.
  • Prior malignancy.
  • History of previous radiotherapy to the abdomen or pelvis.
Show all 11Show fewer
  • Pregnancy or lactation.
  • Active inflammatory bowel disease, or history of severe stomach or duodenal ulcer.
  • Active infection with fever.
  • Patients with unacceptable risk that intracavitary brachytherapy can not be conducted.
  • Any severe disease which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control, and emotional disturbance.

Trial locations and contacts

2 sites in 1 country.

Ke Hu contact

+86-01069155487

huk@pumch.cn

China2 sites, 2 recruiting

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality, 100730

    Ke Hu, MD, 010-69155482, huk@pumch.cn

    Weiping Wang, PhD, 010-69155483, jluwangweiping@163.com

    Recruiting

  • First Affiliated Hospital Xi'an Jiaotong University

    Xi’an, Shanxi

    Zi Liu

    Recruiting

Other trials in China

About this study

Official title: Pelvic Irradiation Versus Prophylactic Extended-field Irradiation in Selected Patients With Cervical Cancer Treated With Concurrent Chemoradiotherapy: A Multicenter, Open-label, Randomized, Phase 3 Trial

To investigate the value of prophylactic extended-field irradiation (EFI), we conduct a randomized clinical trial to compare the efficacy and toxicity of pelvic irradiation and prophylactic EFI in selected patients with cervical cancer treated with definitive concurrent chemoradiotherapy. External beam radiation therapy is delivered with intensity-modulated radiation therapy (IMRT).

Read the detailed description

This is a multicenter, open-label, phase III randomized clinical trial. Cervical cancer patients without evidence of para-aortic metastatic lymph nodes (MLNs) and with at least one of the following characteristics are included in the present study: (a) Number of pelvic MLNs ≥ 2; (b)Short diameter of pelvic MLNs ≥ 1.5cm; (c)Pelvic wall involvement. Patients are randomly assigned to pelvic irradiation group and prophylactic EFI group. Patients in pelvic irradiation group receive pelvic irradiation, intracavitary brachytherapy and concurrent chemotherapy. Patients in prophylactic EFI group receive irradiation for pelvis and para-aortic lymph nodes region, intracavitary brachytherapy and concurrent chemotherapy. The upper border of clinical target volume (CTV) is at the level of renal vessels for patients in prophylactic EFI group. A dose of 45-50.4 Gy is delivered to CTV with IMRT in both groups. Patients receive cisplatin based concurrent chemotherapy (single cisplatin or cisplatin plus paclitaxel). The primary endpoint is progression-free survival.

Being tested
Prophylactic extended-field Irradiation, Pelvic irradiation, Intracavitary brachytherapy, Concurrent chemotherapy
Keywords
Uterine Cervical Neoplasms, Extended-field irradiation
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.

  • Prophylactic extended-field IrradiationRadiation

    Also called Prophylactic radiotherapy for para-aortic lymph nodes region

    CTV covers pelvis and para-aortic lymph nodes region.

  • Pelvic irradiationRadiation

    Also called Pelvic radiotherapy

    CTV covers pelvis.

  • Intracavitary brachytherapyRadiation

    Also called Brachytherapy

    The total dose delivered to point A or high-risk CTV is ≥80Gy. For patients with larger-volume cervical tumor, the total dose is ≥85Gy.

  • Concurrent chemotherapyDrug

    Also called Chemotherapy

    Cisplatin based concurrent chemotherapy, including cisplatin as a single agent or cisplatin plus Paclitaxel.

Study groups in NCT03955367
Study groupRoleWhat they receive
Pelvic IrradiationActive comparatorPatients receive concurrent chemoradiotherapy. The CTV includes the gross tumor, cervix, uterus, parametrium, upper part of the vagina, and pelvic lymph nodes regions. The upper border of CTV is at the level of aortic bifurcation. A dose of 45-50.4Gy is delivered to CTV with IMRT.
Receives: Radiation: Pelvic irradiation; Radiation: Intracavitary brachytherapy; Drug: Concurrent chemotherapy
Prophylactic EFIExperimentalPatients receive concurrent chemoradiotherapy. The CTV includes the gross tumor, cervix, uterus, parametrium, upper part of the vagina, pelvic lymph nodes regions and para-aortic lymph nodes region. The upper border of CTV is at the level of renal vessels. A dose of 45-50.4Gy is delivered to CTV with IMRT.
Receives: Radiation: Prophylactic extended-field Irradiation; Radiation: Intracavitary brachytherapy; Drug: Concurrent chemotherapy

What is being measured

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

  1. Progression-free survival

    Progression-free survival is defined as the time from randomization to disease progression or death from any cause, whichever is first.

    Measured: 3-year

Secondary outcomes (5)

  1. Overall survival

    Overall survival is calculated from randomization to death from any cause.

    Measured: 3-year

  2. Distant failure-free survival

    Distant failure-free survival is defined as the time from randomization to distant metastasis or death from any cause, whichever is first.

    Measured: 3-year

  3. Para-aortic lymph nodes failure rate

    The incidence of para-aortic lymph nodes failure.

    Measured: 3-year

  4. Acute toxicity evaluated with CTCAE 5.0

    Evaluated with CTCAE 5.0

    Measured: From the start of treatment to 3 months after treatment.

  5. Late toxicity evaluated with Radiation Therapy Oncology Group (RTOG)/EORTC late radiation morbidity scoring scheme

    Evaluated with Radiation Therapy Oncology Group (RTOG)/EORTC late radiation morbidity scoring scheme

    Measured: 3-year

Timeline

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

  1. First posted20 May 2019
  2. Study start17 Jun 2019
  3. Primary completion1 Jun 2022 (estimated)
  4. Study completion1 Jun 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
638 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03955367
Sponsor's protocol ID
PUMCH-EFI
Status last verified
Feb 2022
First submitted
11 May 2019
Last updated
23 Feb 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Wang W, Liu X, Meng Q, Zhang F, Hu K. Prophylactic Extended-Field Irradiation for Patients With Cervical Cancer Treated With Concurrent Chemoradiotherapy: A Propensity-Score Matching Analysis. Int J Gynecol Cancer. 2018 Oct;28(8):1584-1591. doi: 10.1097/IGC.0000000000001344.

    PubMed 30153215

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Prophylactic extended-field Irradiation, Pelvic irradiation and Intracavitary brachytherapy in people with Uterine Cervical Neoplasms, run by Peking Union Medical College Hospital at 2 sites 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 14 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: status not confirmed, as of the sponsor's last update on 23 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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.

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 Ke Hu (+86-01069155487, huk@pumch.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival (time frame: 3-year). 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 NCT03955367, which also lists 1 linked publication.

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 23 Feb 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in