AzTrials
AzTrials

Cervical Cancer Stage IVBNCT03175848

Chemotherapy Plus Radiation Therapy in Treating Patients With Primary Stage IVB Cervical Cancer

A study testing Chemotherapy,radiotherapy in people with Cervical Cancer Stage IVB, run by Zhejiang Cancer Hospital at 1 site 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 The sponsor has not verified this record for over two years, so it may be out of date.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

This is a prospective, single arm, phase II trail to assess the effect of primary lesion radiotherapy in the treatment of stage IVB cervical cancer on the basis of systemic chemotherapy. Read more about this study

Who is it for?
Ages 18 to 70 years, women only
Conditions the study is for
Cervical Cancer Stage IVB
What is being tested?
Chemotherapy,radiotherapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
1 siteChina
Study dates
5 May 2017to 31 Oct 2020
Phase
Interventional
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

  • Biopsy-proven, invasive carcinoma of the cervix(squamous cell carcinoma, adenocarcinoma and adenosquamous carcinoma )
  • KPS≥70
  • FIGO stage IVB
  • Age: 18-70
  • ECOG (Eastern Cooperative Oncology Group) : 0-2
  • The expected survival time is >6 months
Show all 9Show fewer
  • Chemotherapy and radiation have not been done before
  • Normal hemodynamic indices before the recruitment (including white blood cell count>4.0×109/L, neutrophil count>1.5×109/L, platelet count >100×109/L, hemoglobin≥90g/l, normal liver/kidney function)
  • Able to understand this study and have signed informed consent.

Who cannot join

  • Prior hysterectomy
  • Metastases lesions are confirmed by pathology or image and are excluded as the second primary neoplasm
  • Patients with brain metastasis or disseminated peritoneal metastasis
  • Female in pregnancy or lactating
  • Hypersensitivity of chemotherapeutic drugs (paclitaxel allergy)
  • History of major psychiatric disorder
Show all 9Show fewer
  • Persons with physical or mental illness, without civil capacity or with limited capacity for civil conduct
  • Patient with any other disease or condition is a contraindication for chemoradiotherapy
  • The researchers consider the patient not appropriate to be enrolled

Trial locations and contacts

1 site in 1 country.

HanMei Lou, M.A. contact

Telephone: 0086-571-88122038

louhanmei@zjcc.org.cn

ZhuoMin Yin contact

0086-571-88122032

yinzm@zjcc.org.cn

China1 site, 1 recruiting

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310022

    HanMei Lou, M.A., 0086-571-88122038, louhanmei@zjcc.org.cn

    ZhuoMin Yin, 0086-571-88122032, yinzm@zjcc.org.cn

    Recruiting

Other trials in China

About this study

Official title: Chemotherapy Plus Radiation Therapy in Treating Patients With Primary Stage IVB Cervical Cancer: A Prospective, Single Arm, Phase II Clinical Trial

This is a prospective, single arm, phase II trail to assess the effect of primary lesion radiotherapy in the treatment of stage IVB cervical cancer on the basis of systemic chemotherapy.

Read the detailed description

Because of the apparent heterogeneity of stage IVB cervical cancer, at present there is no standard treatment.

This is a Phase II, single-center, single-arm, study of systemic chemotherapy plus lesion radiotherapy for primary stage IVB cervical cancer.

The primary objective of the study is to test the hypothesis that primary lesion radiotherapy leads to an improvement in progression-free survival time (PFS)for stage IVB cervical cancer.

For those patients under the clinical management of the recruiting investigator, the investigator will review the patient's medical records and determine if they would be a candidate for the study.

Upon confirmation of all eligibility criteria, the subject will be enrolled.Patients with beyond abdominal pelvic lymph node metastasis will first undergo 2 cycle systemic chemotherapy（TP/TC），then to evaluate the efficacy of chemotherapy, and for patients with chemotherapy effective（CR+PR+SD) followed by the primary lesion of regional radiotherapy (external irradiation plus brachytherapy)，concurrent chemotherapy （TP/TC） may be given according to the patients tolerant，finally, the patient will complete a total of 6 cycles of chemotherapy（TP/TC）.Distant metastasis of lymph node areas (e.g., supraclavicular, axillary, mediastinum, etc.) will be radiation after radiotherapy at the primary site according to patients tolerant.Patients with stage IVB cervical cancer with hematogenous metastasiswill first undergo 4 cycle systemic chemotherapy（TP/TC），then to evaluate the efficacy of chemotherapy, and for patients with chemotherapy effective（CR+PR+SD) followed by the primary lesion of regional radiotherapy (external irradiation plus brachytherapy)，concurrent chemotherapy （TP/TC） may be given according to the patients tolerant，finally, the patient will complete a total of 6 cycles of chemotherapy（TP/TC），after the primary radiotherapy, the treatment regimen for distant metastasis will be determined by MDT discuss or consultation.Quality of life will be evaluated before and after treatment. During therapy, the patient will have a weekly physical exam, vital signs collected, evaluation for pain, and review any side effects.

Subjects will undergo a post treatment follow-up period after completion of their radiation therapy. During this follow-up period, subjects will return for a medical and history review with a complete physical examination, review of any side effects, evaluation for outcomes and toxicity, and QoL.

Being tested
Chemotherapy,radiotherapy
Keywords
Cervical Cancer, Radiotherapy, Chemotherapy, stage IVB cervical cancer
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.

  • Chemotherapy,radiotherapyRadiation

    Pelvic,pelvic-inguinal,or extended field radiotherapy：Therapy 45 - 50 Gy in 1.7 - 2.0 Gy daily fractions over 4.5 - 5.5 weeks for PTV Brachytherapy: Therapy 5-6 fractions of 4-6Gy prescribed to the high-risk CTV or A piont.

Study groups in NCT03175848
Study groupRoleWhat they receive
Chemotherapy,radiotherapyExperimentalLymphatic metastasis patients undergoing 2 cycles of chemotherapy(TP/TC), blood metastasis patients receiving 4 cycles of chemotherapy, then patients with therapeutic evaluation for (CR+PR+SD) will undergo the radiotherapy (external irradiation plus brachytherapy) for primary lesion area , all patients completed total 6 cycles of chemotherapy (TP/TC), and finally will determine the of treatment plans of metastasis areas based on tolerance and discuss results by MDT.
Receives: Radiation: Chemotherapy,radiotherapy

What is being measured

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

  1. Progression-free survival time, PFS

    Progression-free survival will be evaluated

    Measured: 2 years

Secondary outcomes (5)

  1. Number of Patients with Adverse Events as a Measure of Safety

    To quantify rates of acute hematologic, gastrointestinal, and genitourinary toxicity

    Measured: 2 years

  2. Objective Response Rates, ORR

    Objective Response Rates will be evaluated

    Measured: 2 years

  3. Overall survival

    Overall survival will be evaluated

    Measured: 2 years

  4. Ranking Quality of Life of Patients

    To measure health-related quality of life based on the cancer-specific EORTC-QLQ-C30 questionnaire (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 and cervical cancer module(CX24).

    Measured: 2 years

  5. Screening for potentially curable primary stage IVB cervical cancer

    By follow-up data,screening for potentially curable primary stage IVB cervical cancer

    Measured: 2 years

Timeline

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

  1. First posted5 Jun 2017
  2. Study start5 May 2017
  3. Primary completion31 Oct 2018 (estimated)
  4. Study completion31 Oct 2020 (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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
48 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03175848
Sponsor's protocol ID
ZJCH-2017-CRT
Status last verified
May 2017
First submitted
28 May 2017
Last updated
21 Jul 2017
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Chemotherapy,radiotherapy in people with Cervical Cancer Stage IVB, run by Zhejiang 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 9 inclusion and 9 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 Jul 2017. 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?

Results are not available in the source record.

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

Contact HanMei Lou, M.A. (Telephone: 0086-571-88122038, louhanmei@zjcc.org.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, 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 NCT03175848.

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 Jul 2017.

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