Cervical CancerPhase 3PAILACCNCT04974346
Para-aortic Prophylactic Irradiation for Locally Advanced Cervical Cancer
A Phase 3 study testing Paraaortic prophylactic irradiation and pelvic definitive concurrent chemoradiation and Pelvic definitive concurrent chemoradiation in people with Cervical Cancer, run by Zhejiang Cancer Hospital at 7 sites in China.
Trial summary
Para-aortic lymph node metastasis is a poor prognostic factor for locally advanced cervical cancer, but false negative diagnosis is easy to occur. The aim of this trial was to investigate whether para-aortic prophylactic radiotherapy improves disease-free survival in patients with positive pelvic lymph nodes below the… 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?
- Paraaortic prophylactic irradiation and pelvic definitive concurrent chemoradiation and Pelvic definitive concurrent chemoradiation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 455 participants
- Where
- 7 sitesChina
- Study dates
- 2 Aug 2021to 1 Aug 2030
- Phase
- Phase 3
- 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
- The patients voluntarily participated in the study and signed the informed consent
- 18-75 female
- Cervical squamous cell carcinoma / adenocarcinoma / adenosquamous cell carcinoma
- According to International Federation of Gynecology and Obstetrics(FIGO) 2009 stage, stage ⅠB2 - ⅣA with positive pelvic lymph nodes and negative common iliac and paraaortic lymph nodes diagnosed by PET-CT
- Cisplatin chemotherapy is acceptable
- Eastern Cooperative Oncology Group(ECOG) score 0-1
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- The expected survival was more than 6 months
- Women of childbearing age must have a pregnancy test (serum or urine) within 7 days before enrollment, and the result is negative, and they are willing to use appropriate contraceptive methods during the test
- According to the judgment of the researcher, those who can comply with the trial protocol
Who cannot join
- Uncontrolled severe infection
- Combined with other malignant tumor patients who need treatment and / or new diagnosis within 5 years
- The patient has received anti-tumor treatment
- Liver cirrhosis, decompensated liver disease, chronic renal insufficiency and renal failure
- History of immunodeficiency, including HIV positive or other acquired congenital immunodeficiency disease
- Myocardial infarction, severe arrhythmia and grade 2 or more congestive heart failure (NYHA classification)
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- Patients with previous pelvic artery embolization
- Previous radiotherapy for pelvic malignant tumor
- There was a history of severe allergic reaction to platinum containing chemotherapy drugs
- Complications, need to be taken during the treatment of liver and kidney function damage drugs, such as tuberculosis
- The patients who could not understand the content of the experiment and could not cooperate and refused to sign the informed consent
- Patients with accompanying diseases or other special circumstances that seriously endanger the safety of patients or affect the completion of the study
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
China7 sites, 1 recruiting
- Recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022
Xiang Zhang, 0086-571-88122048, zhangxiang@zjcc.org.cn
Xiang Zhang
- Active, not recruiting
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou
- Active, not recruiting
Jinhua Municipal Central Hospital Medical Group
Jinhua
- Active, not recruiting
Lishui People's Hospital
Lishui
- Active, not recruiting
Ningbo First Hospital
Ningbo
- Active, not recruiting
Taizhou Central Hospiatl
Taizhou
- Active, not recruiting
Chongqing University Three Gorges Hospital
Wanzhou
About this study
Official title: Para-aortic Prophylactic Irradiation for Locally Advanced Cervical Cancer: a Prospective, Randomized, Multicenter Study
Para-aortic lymph node metastasis is a poor prognostic factor for locally advanced cervical cancer, but false negative diagnosis is easy to occur. The aim of this trial was to investigate whether para-aortic prophylactic radiotherapy improves disease-free survival in patients with positive pelvic lymph nodes below the common iliac artery.
Read the detailed description
This clinical trial enrolled participants with locally advanced cervical cancer with positive pelvic lymph nodes below the common iliac region diagnosed by Positron emission tomography-computed tomography(PET-CT). Participants should be able to receive concurrent cisplatin chemotherapy. No anti-tumor treatment was given before randomization. Participants will be randomly assigned to two groups. The study group will receive radiotherapy of pelvic and para-aorta, concurrent chemotherapy and brachytherapy, and the control group will receive pelvic radiotherapy, concurrent chemotherapy and brachytherapy.
- Conditions
- Cervical Cancer
- Being tested
- Paraaortic prophylactic irradiation and pelvic definitive concurrent chemoradiation, Pelvic definitive concurrent chemoradiation
- Keywords
- locally advanced cervical cancer, para-aortic radiotherapy, concurrent radiochemotherapy, PET-CT
- 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.
Paraaortic prophylactic irradiation and pelvic definitive concurrent chemoradiationRadiation
The para-aortic area, from left renal vein level to abdominal aorta bifurcation level，will be prophylactic irradiation. The other intervention is the same as control arm.
Pelvic definitive concurrent chemoradiationRadiation
Pelvic definitive concurrent chemoradiation, including external beam radiotherapy, concurrent chemotherapy and brachytherapy.
| Study group | Role | What they receive |
|---|---|---|
| study arm | Experimental | External beam radiotherapy:
Pelvic and para-aortic radiotherapy 45-50.4Gy/25-28 fractions. PET-CT positive lymph node should be boost to a dose of 60Gy or higher. Parametrium(both) should be boost to a dose from 50Gy to 60Gy.
Concurrent chemotherapy:
Weekly cisplatin 40mg/m2 during external beam radiotherapy.
Brachytherapy:
High dose rate(HDR) Brachytherapy. The dose of high-risk clinical target volume(HR CTV) D90 or Point A should be 85Gy+/-10%. The dose of intermediate-risk clinical target volume(IR CTV) D98 should be 60Gy at least. Receives: Radiation: Paraaortic prophylactic irradiation and pelvic definitive concurrent chemoradiation |
| control arm | Active comparator | External beam radiotherapy:
Pelvic radiotherapy 45-50.4Gy/25-28 fractions. PET-CT positive lymph node should be boost to a dose of 60Gy or higher. Parametrium(both) should be boost to a dose from 50Gy to 60Gy.
Concurrent chemotherapy:
Weekly cisplatin 40mg/m2 during external beam radiotherapy.
Brachytherapy:
HDR Brachytherapy. The dose of HR CTV D90 or Point A should be 85Gy+/-10%. The dose of IR CTV D98 should be 60Gy at least. Receives: Radiation: Pelvic definitive concurrent chemoradiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival rate
the percentage of participants in the group whose disease is likely to remain stable
Measured: 3-year
Secondary outcomes (6)
Overall survival rate
the percentage of participants in the group who survives
Measured: 3-year
Para-aortic recurrence rate
the percentage of participants involved by recurrence in the area of para-aortic lymph node
Measured: 3-year
Distant recurrence rate
the percentage of participants involved by recurrence in any organ or tissue except pelvic and para-aortic area
Measured: 3-years
Side effects
side effects associated with treatment
Measured: 3-year
Quality of life (QOL) assessed by EORTC QLQ-C30 v3
an individual's perception of their position in life in the context of the culture and value systems in which they live and in relation to their goals, expectations, standards and concerns (assessed by EORTC QLQ-C30 v3 )
Measured: 1-month and 6-month
Quality of life (QOL) assessed by EORTC QLQ-CX24
an individual's perception of their position in life in the context of the culture and value systems in which they live and in relation to their goals, expectations, standards and concerns (assessed by EORTC QLQ-CX24)
Measured: 1-month and 6-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2021
- Study start2 Aug 2021
- Primary completion1 Aug 2028 (estimated)
- Study completion1 Aug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by Zhejiang Cancer HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 455 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04974346
- Sponsor's protocol ID
- CARTOnG 2101
- Acronym
- PAILACC
- Status last verified
- Jul 2021
- First submitted
- 4 Jul 2021
- Last updated
- 25 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Para-aortic Prophylactic Irradiation for Locally Advanced Cervical Cancer: a Prospective, Randomized, Multicenter Study
- ClinicalTrials.gov ID
- NCT04974346
- Acronym / sponsor ID
- PAILACC / CARTOnG 2101
- Conditions
- Cervical Cancer
- Keywords
- locally advanced cervical cancer, para-aortic radiotherapy, concurrent radiochemotherapy, PET-CT
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 455 participants (estimated)
- Lead sponsor
- Zhejiang Cancer HospitalUniversity, hospital or other
- Study start
- 2 Aug 2021 (actual)
- Primary completion
- 1 Aug 2028 (estimated)
- Study completion
- 1 Aug 2030 (estimated)
- First posted
- 23 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Para-aortic lymph node metastasis is a poor prognostic factor for locally advanced cervical cancer, but false negative diagnosis is easy to occur. The aim of this trial was to investigate whether para-aortic prophylactic radiotherapy improves disease-free survival in patients with positive pelvic lymph nodes below the common iliac artery.
Detailed description
This clinical trial enrolled participants with locally advanced cervical cancer with positive pelvic lymph nodes below the common iliac region diagnosed by Positron emission tomography-computed tomography(PET-CT). Participants should be able to receive concurrent cisplatin chemotherapy. No anti-tumor treatment was given before randomization. Participants will be randomly assigned to two groups. The study group will receive radiotherapy of pelvic and para-aorta, concurrent chemotherapy and brachytherapy, and the control group will receive pelvic radiotherapy, concurrent chemotherapy and brachytherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study arm | Experimental | Radiation: Paraaortic prophylactic irradiation and pelvic definitive concurrent chemoradiationExternal beam radiotherapy: Pelvic and para-aortic radiotherapy 45-50.4Gy/25-28 fractions. PET-CT positive lymph node should be boost to a dose of 60Gy or higher. Parametrium(both) should be boost to a dose from 50Gy to 60Gy. Concurrent chemotherapy: Weekly cisplatin 40mg/m2 during external beam radiotherapy. Brachytherapy: High dose rate(HDR) Brachytherapy. The dose of high-risk clinical target volume(HR CTV) D90 or Point A should be 85Gy+/-10%. The dose of intermediate-risk clinical target volume(IR CTV) D98 should be 60Gy at least. |
| control arm | Active comparator | Radiation: Pelvic definitive concurrent chemoradiationExternal beam radiotherapy: Pelvic radiotherapy 45-50.4Gy/25-28 fractions. PET-CT positive lymph node should be boost to a dose of 60Gy or higher. Parametrium(both) should be boost to a dose from 50Gy to 60Gy. Concurrent chemotherapy: Weekly cisplatin 40mg/m2 during external beam radiotherapy. Brachytherapy: HDR Brachytherapy. The dose of HR CTV D90 or Point A should be 85Gy+/-10%. The dose of IR CTV D98 should be 60Gy at least. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- The patients voluntarily participated in the study and signed the informed consent
- 18-75 female
- Cervical squamous cell carcinoma / adenocarcinoma / adenosquamous cell carcinoma
- According to International Federation of Gynecology and Obstetrics(FIGO) 2009 stage, stage ⅠB2 - ⅣA with positive pelvic lymph nodes and negative common iliac and paraaortic lymph nodes diagnosed by PET-CT
- Cisplatin chemotherapy is acceptable
Key exclusion criteria (12 listed)
- Uncontrolled severe infection
- Combined with other malignant tumor patients who need treatment and / or new diagnosis within 5 years
- The patient has received anti-tumor treatment
- Liver cirrhosis, decompensated liver disease, chronic renal insufficiency and renal failure
- History of immunodeficiency, including HIV positive or other acquired congenital immunodeficiency disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Paraaortic prophylactic irradiation and pelvic definitive concurrent chemoradiationThe para-aortic area, from left renal vein level to abdominal aorta bifurcation level，will be prophylactic irradiation. The other intervention is the same as control arm. | Radiation | study arm |
| Pelvic definitive concurrent chemoradiationPelvic definitive concurrent chemoradiation, including external beam radiotherapy, concurrent chemotherapy and brachytherapy. | Radiation | control arm |
Primary outcome
Progression-free survival rate
Time frame: 3-year
the percentage of participants in the group whose disease is likely to remain stable
6 secondary outcomes
Overall survival rate
Time frame: 3-year
Para-aortic recurrence rate
Time frame: 3-year
Distant recurrence rate
Time frame: 3-years
Side effects
Time frame: 3-year
Quality of life (QOL) assessed by EORTC QLQ-C30 v3
Time frame: 1-month and 6-month
Quality of life (QOL) assessed by EORTC QLQ-CX24
Time frame: 1-month and 6-month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Paraaortic prophylactic irradiation and pelvic definitive concurrent chemoradiation and Pelvic definitive concurrent chemoradiation in people with Cervical Cancer, run by Zhejiang Cancer Hospital at 7 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 9 inclusion and 12 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 25 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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?
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 Xiang Zhang (0086-571-88122148, zhangxiang@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 rate (time frame: 3-year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Jan 2022.