Cervical CancerPhase 3NCT00146458
Usefulness of FDG-PET for Advanced Cervical Cancer
A Phase 3 study testing 18F-fluorodeoxyglucose positron emission tomography in people with Cervical Cancer, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
The objective of this study is to determinate whether the adding of FDG-PET is helpful in the treatment of advanced cervical cancer with concurrent chemoradiation. Read more about this study
- Who is it for?
- Ages 0 years and older, women only
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- 18F-fluorodeoxyglucose positron emission tomography
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2002to Dec 2007
- 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 0 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Newly diagnosed cervical cancer clinical stage FIGO I -IVA
- Histologically proven cervical carcinoma (including histologic types of squamous cell carcinoma, adenocarcinoma, adenosquamous carcinoma, adenoid cystic carcinoma, lymphoepithelial-like carcinoma and malignant mixed mullerian tumor)
- Presence of at least one enlarged pelvic lymph node (>=1.0 cm in its maximal dimension), or group of small pelvic nodes (size <1 cm), and without suspicious para-aortic lymph node metastasis or any lesion outside the pelvis by conventional MRI or CT study
- Karnofsky performance scale >=60
- Available for concurrent chemoradiation therapy of curative intent
Who cannot join
- Cervical tumor with histologic diagnosis of verrucous carcinoma or small cell carcinoma
- Other serious illness or medical condition which would interfere with extended field irradiation or chemotherapy
- Past or current history of malignancy, except for curatively treated non-melanoma skin cancer
- Patients not suitable to receive PET study either by technical or psychological reasons
- Patients who are judged to be noncompliant to treatment or not accessible for follow up
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Department of Radiation Oncology, Chang Gung Memorial Hospital
Taoyuan, 333
About this study
Official title: A Phase III Randomized Trial of FDG-PET in the Management of Advanced Cervical Cancer With Enlarged Pelvic Lymph Node on MRI Image
The objective of this study is to determinate whether the adding of FDG-PET is helpful in the treatment of advanced cervical cancer with concurrent chemoradiation.
Read the detailed description
Concurrent radiotherapy and chemotherapy is the standard treatment for locally advanced cervical cancer. The radiation field should be adjusted according to the extension of disease, especially the presence of metastatic lymph nodes. At present, CT/ MRI have been applied for the detection of enlarged lymph nodes, as the reference of radiation field. However, not infrequently, a small-sized lymph node on CT/MRI may be metastatic while an enlarged node may be resulted from reactive hyperplasia.
Unlike CT/ MRI, 18F-FDG positron emission tomography (FDG-PET) provides a novel means of imaging malignancy and could differentiate benign tumor from malignancy by functional assessment. Recent studies demonstrated higher accuracy of FDG-PET scan for the evaluation of metastasis in patients with several types of cancers when compared with CT scan or MRI. But, only a few reports concerned the usefulness of FDG-PET in cervical carcinoma.
Our hypothesis is that adding FGD-PET study to a thorough MRI can provide better staging, especially on the identification of metastatic pelvic or para-aortic lymph nodes. In addition, this whole body scan may also detect occult distant metastases that are not detectable by standard workup. Our initial result of a phase II study---"A Preliminary Report of Using FDG-PET to Detect Extra-pelvic Lesions in Cervical Cancer Patients with Enlarged Pelvic Lymph Nodes Shown on MRI/CT Images" indicated that FDG-PET helped to detect occult or small metastatic lesions, and resulted in a change of radiation treatment plan. Nevertheless, for high-risk group patients, distant metastasis still occurred in a short period after treatment. Therefore, it is also our question that whether the enhancement of detection provided by FDG-PET can be translated into improvement of final overall survival.
To answer these questions, the Gynecologic Oncology Study Group in Chang Gung Memorial Hospital has designed a phase III clinical study. Patients with enlarged pelvic lymph node detected on MRI imaging are enrolled and randomized into two groups before the initiation of concurrent chemoradiation.
- Conditions
- Cervical Cancer
- Being tested
- 18F-fluorodeoxyglucose positron emission tomography
- Keywords
- Cervical cancer, FDG-PET, Lymph node metastasis, Radiotherapy, Chemotherapy
- Medical subject headings
- Uterine Cervical Neoplasms, Lymphatic Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-fluorodeoxyglucose positron emission tomographyProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference of disease-free-survival and overall-survival with/ without FDG-PET at two years after treatment
Secondary outcomes (1)
The incidence of additional extra-pelvic tumor metastasis detected by FDG-PET study, and its influence on the design of appropriate radiotherapy treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2005 (estimated)
- Study startJan 2002
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Investigators
- Chien-Sheng Tsai, M.D., Principal investigator, Department of Radiation Oncology, Chang Gung Memorial HospitalTin-Chang Chang, M.D., MPH., Study director, Director of Division of Gynecologic Oncology, Chang Gung Memorial Hospital, Linkou Medical CenterChyong-Huey Lai, M.D., Study chair, Chairman of Department of Obstetrics and Gynecology, Chang Gung Memorial Hospital, Linkou Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00146458
- Sponsor's protocol ID
- CTRP024
- Other IDs
- NSC 92-2314-B-182A-084
- Status last verified
- Sep 2006
- First submitted
- 6 Sep 2005
- Last updated
- 20 Sep 2006
- Results posted
- No
Publications
Tsai CS, Chang TC, Lai CH, Tsai CC, Ng KK, Hsueh S, Yen TC, Hong JH. Preliminary report of using FDG-PET to detect extrapelvic lesions in cervical cancer patients with enlarged pelvic lymph nodes on MRI/CT. Int J Radiat Oncol Biol Phys. 2004 Apr 1;58(5):1506-12. doi: 10.1016/j.ijrobp.2003.09.013.
PubMed 15050330
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Randomized Trial of FDG-PET in the Management of Advanced Cervical Cancer With Enlarged Pelvic Lymph Node on MRI Image
- ClinicalTrials.gov ID
- NCT00146458
- Acronym / sponsor ID
- CTRP024
- Conditions
- Cervical Cancer
- Keywords
- Cervical cancer, FDG-PET, Lymph node metastasis, Radiotherapy, Chemotherapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Study start
- Jan 2002
- Study completion
- Dec 2007
- First posted
- 7 Sep 2005 (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.
The objective of this study is to determinate whether the adding of FDG-PET is helpful in the treatment of advanced cervical cancer with concurrent chemoradiation.
Detailed description
Concurrent radiotherapy and chemotherapy is the standard treatment for locally advanced cervical cancer. The radiation field should be adjusted according to the extension of disease, especially the presence of metastatic lymph nodes. At present, CT/ MRI have been applied for the detection of enlarged lymph nodes, as the reference of radiation field. However, not infrequently, a small-sized lymph node on CT/MRI may be metastatic while an enlarged node may be resulted from reactive hyperplasia.
Unlike CT/ MRI, 18F-FDG positron emission tomography (FDG-PET) provides a novel means of imaging malignancy and could differentiate benign tumor from malignancy by functional assessment. Recent studies demonstrated higher accuracy of FDG-PET scan for the evaluation of metastasis in patients with several types of cancers when compared with CT scan or MRI. But, only a few reports concerned the usefulness of FDG-PET in cervical carcinoma.
Our hypothesis is that adding FGD-PET study to a thorough MRI can provide better staging, especially on the identification of metastatic pelvic or para-aortic lymph nodes. In addition, this whole body scan may also detect occult distant metastases that are not detectable by standard workup. Our initial result of a phase II study---"A Preliminary Report of Using FDG-PET to Detect Extra-pelvic Lesions in Cervical Cancer Patients with Enlarged Pelvic Lymph Nodes Shown on MRI/CT Images" indicated that FDG-PET helped to detect occult or small metastatic lesions, and resulted in a change of radiation treatment plan. Nevertheless, for high-risk group patients, distant metastasis still occurred in a short period after treatment. Therefore, it is also our question that whether the enhancement of detection provided by FDG-PET can be translated into improvement of final overall survival.
To answer these questions, the Gynecologic Oncology Study Group in Chang Gung Memorial Hospital has designed a phase III clinical study. Patients with enlarged pelvic lymph node detected on MRI imaging are enrolled and randomized into two groups before the initiation of concurrent chemoradiation.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 0 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Newly diagnosed cervical cancer clinical stage FIGO I -IVA
- Histologically proven cervical carcinoma (including histologic types of squamous cell carcinoma, adenocarcinoma, adenosquamous carcinoma, adenoid cystic carcinoma, lymphoepithelial-like carcinoma and malignant mixed mullerian tumor)
- Presence of at least one enlarged pelvic lymph node (>=1.0 cm in its maximal dimension), or group of small pelvic nodes (size <1 cm), and without suspicious para-aortic lymph node metastasis or any lesion outside the pelvis by conventional MRI or CT study
- Karnofsky performance scale >=60
- Available for concurrent chemoradiation therapy of curative intent
Key exclusion criteria (5 listed)
- Cervical tumor with histologic diagnosis of verrucous carcinoma or small cell carcinoma
- Other serious illness or medical condition which would interfere with extended field irradiation or chemotherapy
- Past or current history of malignancy, except for curatively treated non-melanoma skin cancer
- Patients not suitable to receive PET study either by technical or psychological reasons
- Patients who are judged to be noncompliant to treatment or not accessible for follow up
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 |
|---|---|---|
| 18F-fluorodeoxyglucose positron emission tomography | Procedure or surgery | – |
Primary outcome
The difference of disease-free-survival and overall-survival with/ without FDG-PET at two years after treatment
1 secondary outcome
The incidence of additional extra-pelvic tumor metastasis detected by FDG-PET study, and its influence on the design of appropriate radiotherapy treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2006.
- Results publication: PubMed 15050330Tsai CS, Chang TC, Lai CH, Tsai CC, Ng KK, Hsueh S, Yen TC, Hong JH. Preliminary report of using FDG-PET to detect extrapelvic lesions in cervical cancer patients with enlarged pelvic lymph nodes on MRI/CT. Int J Radiat Oncol Biol Phys. 2004 Apr 1;58(5):1506-12. doi: 10.1016/j.ijrobp.2003.09.013.
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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.
Chien-Sheng Tsai, M.D. principal investigator
Department of Radiation Oncology, Chang Gung Memorial Hospital
Tin-Chang Chang, M.D., MPH. study director
Director of Division of Gynecologic Oncology, Chang Gung Memorial Hospital, Linkou Medical Center
Chyong-Huey Lai, M.D. study chair
Chairman of Department of Obstetrics and Gynecology, Chang Gung Memorial Hospital, Linkou Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 18F-fluorodeoxyglucose positron emission tomography in people with Cervical Cancer, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 5 inclusion and 5 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 20 Sep 2006. 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 Taiwan. 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?
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?
The difference of disease-free-survival and overall-survival with/ without FDG-PET at two years after treatment. 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 NCT00146458, 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 20 Sep 2006.