Cervical CancerNCT00980759
Prophylactic Irradiation of the Para-Aortic Lymph Nodes in Locally Advanced Uterine Cervical Cancer
A study testing EFI and Pelvic RT in people with Cervical Cancer, run by National Cancer Center, Korea at 1 site in South Korea.
Trial summary
This study is an open-label, multi-institutional, randomized phase II study, which is designed to investigate the efficacy of Extended-field irradiation (EFI) on reducing recurrences at the para-aortic lymph node (PAN), and also on improving disease-free survival of locally advanced uterine cervical cancer. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- EFI and Pelvic RT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 312 participants
- Where
- 1 siteSouth Korea
- Study dates
- 28 Jul 2006to 31 Dec 2024
- 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 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients (who have been adequately clinically staged) with primary, untreated, histologically confirmed invasive squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the uterine cervix, FIGO stage IB1 with pelvic lymph node metastasis, IB2, IIA(≥4cm in tumor size, or pelvic LN metastasis), IIB, IIIA, IIIB with only unilateral pelvic wall extension, and IVA
- Patients with negative, para-aortic lymphadenopathy determined by pelvic MRI and/or PET/CT scan.
- Patients with adequate bone marrow function: ANC greater than or equal to 1,500/ul, platelets greater than or equal to 100,000/ul at the beginning.
- Patients with adequate renal function: creatinine equal to or less than 2.0 mg/dL.
- Patients who have signed an approved informed consent and authorization
- Patients who have met the pre-entry requirements specified in section 6.0.
- Patients with ECOG Performance Status of 0, 1, 2 and Karnofsky Performance Scale of 100, 90, 80, 70, 60, 50
- Age: 18≤age≤80
Who cannot join
- Stage IIIb with bilateral pelvic wall extension and stage IVB lesions are not eligible.
- Patients with histology other than squamous, adeno, adenosquamous cell carcinoma
- Patients who have received prior radiotherapy of pelvis or total hysterectomy Patients who have diagnosis of other malignant tumors other than non- malignant melanoma skin cancer or stage I. II papillary, follicular thyroid cancer.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
National Cancer Center, Korea
Goyang-si, Gyeonggi-do, 410-769
About this study
Official title: A Phase II Randomized Study of Prophylactic Irradiation of the Para-Aortic Lymph Nodes by 3-D Conformal Radiotherapy Technique With Concurrent Chemotherapy Based on the Hypoxic Status of Locally Advanced Uterine Cervical Cancer
This study is an open-label, multi-institutional, randomized phase II study, which is designed to investigate the efficacy of Extended-field irradiation (EFI) on reducing recurrences at the para-aortic lymph node (PAN), and also on improving disease-free survival of locally advanced uterine cervical cancer. Radiotherapy is given as a conformal technique based on the individually taken CT scan and cisplatin is given concomitantly with radiotherapy in both EFI arm and pelvis only treatment arm. According to our past study result, patients with more hypoxic tumors are more likely to develop distant metastasis including the recurrences at PAN (1-3). This study started with examination of CA9 (hypoxia marker) expression in the primary cervical tumor before randomization because it was expected that there would be a differential benefit of EFI in patients with CA9-positive vs CA9-negative tumors. However, the study design was modified because there was too much delay in the patient with CA9-negative tumors. The patients are now registered and then immediately randomized to experimental (EFI) and control arm (pelvis only treated) with examination of CA9 expression at later time.
Read the detailed description
Patients with primary, untreated, histologically confirmed carcinoma of the uterine cervix are included in this study. Absence of metastatic para-aortic lymphadenopathy is the prerequisite of the enrollment, and this is confirmed by imaging studies such as MRI covering the abdomen and pelvis, and PET/CT scan. The sample size is based on the previous studies (1-3). Considering that the disease-free survival of the experimental arm (patients who are treated with prophylactic para-aortic LN irradiation) and those who are not treated is 82% vs 72% (preliminary analysis), with the alpha error of 5% and statistical power of 90% (one-sided), a total of 140 patients in each treatment arm is needed. With 10% of follow-up loss taken into account, the total number of patients will be 312. Above figures were calculated on the basis of 80% statistical power and 5% type I error rate. PAN is treated prophylactically in the experimental arm with 45Gy/25F/5week fractionation schedule. Pelvis is treated according to the individual institute's practice guideline. Boost treatment for any enlarged pelvic lymph node or residual cervical/ parametrial disease with conformal radiation technique are allowed. Intracavitary radiation is given via low-dose-rate or high-dose-rate brachytherapy technique. Weekly cisplatin is given to all patients, however, when the patient's physical condition does not allow cisplatin administration, it can be omitted. This should be taken into account in the final analysis. The stage and the presence of pelvic lymphadenopathy are two stratification factors.
- Conditions
- Cervical Cancer
- Being tested
- EFI, Pelvic RT
- Keywords
- Extended-field Irradiation (EFI), Cervical cancer, Hypoxia, Carbonic anhydrase 9 (CA9), locally advanced uterine cervical cancer
- Medical subject headings
- Uterine Cervical Neoplasms, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EFIRadiation
Also called Extended-field Irradiation
Para-aortic and Pelvic Irradiation with chemotherapy(cisplatin)
Pelvic RTRadiation
Also called Pelvic only treatment
Only Pelvic Irradiation with chemotherapy(cisplatin)
| Study group | Role | What they receive |
|---|---|---|
| EFI(Extended-Field Irradiation) | Experimental | Para-aortic and Pelvic Irradiation with chemotherapy(cisplatin) Receives: Radiation: EFI |
| Pelvic RT | Experimental | Pelvic Irradiation with chemotherapy(cisplatin) Receives: Radiation: Pelvic RT |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the efficacy of the Extended-Field Irradiation on the recurrence rate in para-aortic lymph nodes and the disease-free survival rate of the patients with locally advanced uterine cervical cancer
Measured: 5 years
Secondary outcomes (1)
To evaluate overall survival, toxicities and quality of life (QOL) of the patients treated by EFI compared to the control group of patients
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2009 (estimated)
- Study start28 Jul 2006
- Primary completion30 Nov 2019
- Study completion31 Dec 2024 (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.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomization of Radiotherapy field
- Masking
- None (open label)
- Enrolment
- 312 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Center, Korea
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Joo-Young Kim, National Cancer Center, Korea
- Investigators
- Joo-young J Kim, M.D., Ph.D., Principal investigator, National Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00980759
- Sponsor's protocol ID
- NCCCTS-06-209
- Status last verified
- Aug 2021
- First submitted
- 18 Sep 2009
- Last updated
- 8 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Randomized Study of Prophylactic Irradiation of the Para-Aortic Lymph Nodes by 3-D Conformal Radiotherapy Technique With Concurrent Chemotherapy Based on the Hypoxic Status of Locally Advanced Uterine Cervical Cancer
- ClinicalTrials.gov ID
- NCT00980759
- Acronym / sponsor ID
- NCCCTS-06-209
- Conditions
- Cervical Cancer
- Keywords
- Extended-field Irradiation (EFI), Cervical cancer, Hypoxia, Carbonic anhydrase 9 (CA9), locally advanced uterine cervical cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 312 participants (estimated)
- Lead sponsor
- National Cancer Center, KoreaOther government
- Study start
- 28 Jul 2006
- Primary completion
- 30 Nov 2019 (actual)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 21 Sep 2009 (estimated)
- 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.
This study is an open-label, multi-institutional, randomized phase II study, which is designed to investigate the efficacy of Extended-field irradiation (EFI) on reducing recurrences at the para-aortic lymph node (PAN), and also on improving disease-free survival of locally advanced uterine cervical cancer. Radiotherapy is given as a conformal technique based on the individually taken CT scan and cisplatin is given concomitantly with radiotherapy in both EFI arm and pelvis only treatment arm. According to our past study result, patients with more hypoxic tumors are more likely to develop distant metastasis including the recurrences at PAN (1-3). This study started with examination of CA9 (hypoxia marker) expression in the primary cervical tumor before randomization because it was expected that there would be a differential benefit of EFI in patients with CA9-positive vs CA9-negative tumors. However, the study design was modified because there was too much delay in the patient with CA9-negative tumors. The patients are now registered and then immediately randomized to experimental (EFI) and control arm (pelvis only treated) with examination of CA9 expression at later time.
Detailed description
Patients with primary, untreated, histologically confirmed carcinoma of the uterine cervix are included in this study. Absence of metastatic para-aortic lymphadenopathy is the prerequisite of the enrollment, and this is confirmed by imaging studies such as MRI covering the abdomen and pelvis, and PET/CT scan. The sample size is based on the previous studies (1-3). Considering that the disease-free survival of the experimental arm (patients who are treated with prophylactic para-aortic LN irradiation) and those who are not treated is 82% vs 72% (preliminary analysis), with the alpha error of 5% and statistical power of 90% (one-sided), a total of 140 patients in each treatment arm is needed. With 10% of follow-up loss taken into account, the total number of patients will be 312. Above figures were calculated on the basis of 80% statistical power and 5% type I error rate. PAN is treated prophylactically in the experimental arm with 45Gy/25F/5week fractionation schedule. Pelvis is treated according to the individual institute's practice guideline. Boost treatment for any enlarged pelvic lymph node or residual cervical/ parametrial disease with conformal radiation technique are allowed. Intracavitary radiation is given via low-dose-rate or high-dose-rate brachytherapy technique. Weekly cisplatin is given to all patients, however, when the patient's physical condition does not allow cisplatin administration, it can be omitted. This should be taken into account in the final analysis. The stage and the presence of pelvic lymphadenopathy are two stratification factors.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomization of Radiotherapy field
| Arm | Type | Receives |
|---|---|---|
| EFI(Extended-Field Irradiation) | Experimental | Radiation: EFIPara-aortic and Pelvic Irradiation with chemotherapy(cisplatin) |
| Pelvic RT | Experimental | Radiation: Pelvic RTPelvic Irradiation with chemotherapy(cisplatin) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients (who have been adequately clinically staged) with primary, untreated, histologically confirmed invasive squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the uterine cervix, FIGO stage IB1 with pelvic lymph node metastasis, IB2, IIA(≥4cm in tumor size, or pelvic LN metastasis), IIB, IIIA, IIIB with only unilateral pelvic wall extension, and IVA
- Patients with negative, para-aortic lymphadenopathy determined by pelvic MRI and/or PET/CT scan.
- Patients with adequate bone marrow function: ANC greater than or equal to 1,500/ul, platelets greater than or equal to 100,000/ul at the beginning.
- Patients with adequate renal function: creatinine equal to or less than 2.0 mg/dL.
- Patients who have signed an approved informed consent and authorization
Key exclusion criteria (3 listed)
- Stage IIIb with bilateral pelvic wall extension and stage IVB lesions are not eligible.
- Patients with histology other than squamous, adeno, adenosquamous cell carcinoma
- Patients who have received prior radiotherapy of pelvis or total hysterectomy Patients who have diagnosis of other malignant tumors other than non- malignant melanoma skin cancer or stage I. II papillary, follicular thyroid cancer.
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 |
|---|---|---|
| EFIAlso: Extended-field IrradiationPara-aortic and Pelvic Irradiation with chemotherapy(cisplatin) | Radiation | EFI(Extended-Field Irradiation) |
| Pelvic RTAlso: Pelvic only treatmentOnly Pelvic Irradiation with chemotherapy(cisplatin) | Radiation | Pelvic RT |
Primary outcome
To evaluate the efficacy of the Extended-Field Irradiation on the recurrence rate in para-aortic lymph nodes and the disease-free survival rate of the patients with locally advanced uterine cervical cancer
Time frame: 5 years
1 secondary outcome
To evaluate overall survival, toxicities and quality of life (QOL) of the patients treated by EFI compared to the control group of patients
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2021.
- Individual participant dataSharing planned: Undecided. undecided
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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. This study is not recruiting at the moment.
Joo-young J Kim, M.D., Ph.D. principal investigator
National Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EFI and Pelvic RT in people with Cervical Cancer, run by National Cancer Center, Korea at 1 site in South Korea.
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 8 inclusion and 3 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 8 Sep 2021. 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 South Korea. 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?
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?
To evaluate the efficacy of the Extended-Field Irradiation on the recurrence rate in para-aortic lymph nodes and the disease-free survival rate of the patients with locally advanced uterine cervical cancer (time frame: 5 years). 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 8 Sep 2021.