Cervical CancerPhase 3STARSNCT00806117
Comparison of Different Subsequent Treatments After Radical Surgery
A Phase 3 study testing Radiotherapy (RT), Concurrent chemoirradiation (CCRT) and Sequence chemotherapy and radiotherapy (SCRT) in people with Cervical Cancer, run by Sun Yat-sen University at 1 site in China.
Trial summary
Cervical cancer is still the most common gynecologic cancer. There was no obvious increase of the survival over years. The risk of recurrence after radical surgery has increased with positive lymph nodes, positive surgical margins, positive lymphatic vascular space and deep invasion of the cervical stroma. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- Radiotherapy (RT), Concurrent chemoirradiation (CCRT) and Sequence chemotherapy and radiotherapy (SCRT)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,080 participants
- Where
- 1 siteChina
- Study dates
- 25 Feb 2008to 31 Dec 2020
- 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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with newly histologically confirmed cervical carcinoma
- Original clinical stage must be Ib~IIa （FIGO）
- Age between 18-65
- With the presence of these four factors after radical surgery:(1)positive lymph nodes,(2)positive parametria, or positive surgical margins,(3)positive lymphatic vascular space,(4)outer one-third invasion of the cervical stroma
- More than 3 months survival is to expect
- Patients must give signed informed consent
Who cannot join
- The presence of uncontrolled life-threatening illness
- Receiving other ways of anti-cancer therapy
- Residual tumor which can not be removed in the surgery
- Investigator consider the patients can't finish the whole study
- With normal liver function test (ALT、AST>2.5×ULN)
- With normal renal function test (Creatinine>1.5×ULN)
- WBC<4,000/mm3 or PLT<100,000/mm3
- Receive the external pelvic irradiation before the surgery
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Gynecologic Oncology, Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
About this study
Official title: Comparison of Different Adjuvant Treatments Following Radical Surgery in Early Stage Cervical Carcinoma
Cervical cancer is still the most common gynecologic cancer. There was no obvious increase of the survival over years. The risk of recurrence after radical surgery has increased with positive lymph nodes, positive surgical margins, positive lymphatic vascular space and deep invasion of the cervical stroma. In recent years, the role of chemotherapy for cervical cancer has been gradually recognized. But as a adjuvant therapy post-surgery, if chemotherapy can improve the overall survival rate of patients with adverse pathological prognostic factors is inconclusive.
In this study, in order to investigate the effect and adverse reaction of chemotherapy as the adjuvant therapy post-surgery on patients with adverse pathological prognostic factors, nine hundred and ninety patients will be randomly divided into three groups, comparing radiotherapy alone, concurrent chemoradiation and sequence chemotherapy and radiotherapy (2 cycles chemotherapy of Paclitaxel and Cisplatin before and after the irradiation). The investigators aim to find out the best therapeutic regimen with lowest adverse reaction for cervical cancer with adverse pathological prognostic factors. To guide clinical treatment options.
Read the detailed description
After radical surgery, patients with stage IB1 to IIA2 cervical cancer who had one or more following pathological factors were recruited: lymph node metastases (LNM), positive parametrium or margins (PPM), lymphatic vascular space involvement (LVSI), deep invasion of cervical stromal (DIS). Eligible patients were randomized to three groups. Group A underwent 50 GY RT alone. Group B received concurrent weekly cisplatin and RT. Group C received paclitaxel and bolus cisplatin every three weeks for two cycles before RT, followed by two cycles.
We have recruited 800 patients till November 2014.
- Conditions
- Cervical Cancer
- Being tested
- Radiotherapy (RT), Concurrent chemoirradiation (CCRT), Sequence chemotherapy and radiotherapy (SCRT)
- Keywords
- Cervical cancer, Concurrent chemoradiation, Randomized controlled clinical trials
- 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.
Radiotherapy (RT)Radiation
External irradiation 50Gy/5 weeks
- Lateral: 2 cm lateral to the bony margin of the pelvis
- Superior: Between L5 and S1
- Inferior: 2 cm below the obturator foramen Intracavitary boost 30-35Gy/4 weeks(positive vaginal margins only)
Concurrent chemoirradiation (CCRT)Other
Cisplatin 40mg/m2 every week during external irradiation
Sequence chemotherapy and radiotherapy (SCRT)Other
Paclitaxel 135~175mg/m2 over 3 hours Cisplatin 60~75mg/m2
| Study group | Role | What they receive |
|---|---|---|
| Radiotherapy (RT) | Active comparator | Radiotherapy Receives: Radiation: Radiotherapy (RT) |
| Concurrent chemoirradiation (CCRT) | Experimental | Concurrent chemoirradiation:
External beam radiation with concurrent weekly platinum chemotherapy Receives: Other: Concurrent chemoirradiation (CCRT) |
| Sequence chemo and radiation (SCRT) | Experimental | Sequence chemotherapy and radiotherapy:
2 cycles chemotherapy of Paclitaxel and Cisplatin before and after the irradiation Receives: Other: Sequence chemotherapy and radiotherapy (SCRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease Free Survival
DFS survival analysis
Measured: 3-Yr
Secondary outcomes (1)
Overall Survival
OS survival analysis
Measured: 5-Yr
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2008 (estimated)
- Study start25 Feb 2008
- Primary completion31 Dec 2018
- Study completion31 Dec 2020 (estimated)
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 Sun Yat-sen UniversityThe 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
- Model description
- After radical surgery, eligible patients with risk pathological factors were randomize to three groups. Radiotherapy: Group A underwent 50 GY pelvic RT alone. Radiotherapy and drugs: Group B received concurrent weekly cisplatin and RT (CCRT). Radiotherapy and drugs: Group C received paclitaxel and bolus cisplatin every three weeks for two cycles before RT, followed by two cycles of chemotherapy (SCRT).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,080 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Collaborators
- Guangdong Provincial People's Hospital, First Affiliated Hospital, Sun Yat-Sen University, Shenzhen People's Hospital, Cancer Hospital of Guangxi Medical University
- Responsible party
- Principal investigator, Jihong Liu, Sun Yat-sen University
- Investigators
- Jihong Liu, Ph.D., Study chair, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00806117
- Sponsor's protocol ID
- SYSU50102008049
- Acronym
- STARS
- Status last verified
- Jul 2019
- First submitted
- 8 Dec 2008
- Last updated
- 30 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Huang H, Feng YL, Wan T, Zhang YN, Cao XP, Huang YW, Xiong Y, Huang X, Zheng M, Li YF, Li JD, Chen GD, Li H, Chen YL, Ma LG, Yang HY, Li L, Yao SZ, Ye WJ, Tu H, Huang QD, Liang LZ, Liu FY, Liu Q, Liu JH. Effectiveness of Sequential Chemoradiation vs Concurrent Chemoradiation or Radiation Alone in Adjuvant Treatment After Hysterectomy for Cervical Cancer: The STARS Phase 3 Randomized Clinical Trial. JAMA Oncol. 2021 Mar 1;7(3):361-369. doi: 10.1001/jamaoncol.2020.7168.
PubMed 33443541
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Different Adjuvant Treatments Following Radical Surgery in Early Stage Cervical Carcinoma
- ClinicalTrials.gov ID
- NCT00806117
- Acronym / sponsor ID
- STARS / SYSU50102008049
- Conditions
- Cervical Cancer
- Keywords
- Cervical cancer, Concurrent chemoradiation, Randomized controlled clinical trials
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,080 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- Guangdong Provincial People's Hospital, First Affiliated Hospital, Sun Yat-Sen University, Shenzhen People's Hospital, Cancer Hospital of Guangxi Medical University
- Study start
- 25 Feb 2008 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 10 Dec 2008 (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.
Cervical cancer is still the most common gynecologic cancer. There was no obvious increase of the survival over years. The risk of recurrence after radical surgery has increased with positive lymph nodes, positive surgical margins, positive lymphatic vascular space and deep invasion of the cervical stroma. In recent years, the role of chemotherapy for cervical cancer has been gradually recognized. But as a adjuvant therapy post-surgery, if chemotherapy can improve the overall survival rate of patients with adverse pathological prognostic factors is inconclusive.
In this study, in order to investigate the effect and adverse reaction of chemotherapy as the adjuvant therapy post-surgery on patients with adverse pathological prognostic factors, nine hundred and ninety patients will be randomly divided into three groups, comparing radiotherapy alone, concurrent chemoradiation and sequence chemotherapy and radiotherapy (2 cycles chemotherapy of Paclitaxel and Cisplatin before and after the irradiation). The investigators aim to find out the best therapeutic regimen with lowest adverse reaction for cervical cancer with adverse pathological prognostic factors. To guide clinical treatment options.
Detailed description
After radical surgery, patients with stage IB1 to IIA2 cervical cancer who had one or more following pathological factors were recruited: lymph node metastases (LNM), positive parametrium or margins (PPM), lymphatic vascular space involvement (LVSI), deep invasion of cervical stromal (DIS). Eligible patients were randomized to three groups. Group A underwent 50 GY RT alone. Group B received concurrent weekly cisplatin and RT. Group C received paclitaxel and bolus cisplatin every three weeks for two cycles before RT, followed by two cycles.
We have recruited 800 patients till November 2014.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- After radical surgery, eligible patients with risk pathological factors were randomize to three groups. Radiotherapy: Group A underwent 50 GY pelvic RT alone. Radiotherapy and drugs: Group B received concurrent weekly cisplatin and RT (CCRT). Radiotherapy and drugs: Group C received paclitaxel and bolus cisplatin every three weeks for two cycles before RT, followed by two cycles of chemotherapy (SCRT).
| Arm | Type | Receives |
|---|---|---|
| Radiotherapy (RT) | Active comparator | Radiation: Radiotherapy (RT)Radiotherapy |
| Concurrent chemoirradiation (CCRT) | Experimental | Other: Concurrent chemoirradiation (CCRT)Concurrent chemoirradiation: External beam radiation with concurrent weekly platinum chemotherapy |
| Sequence chemo and radiation (SCRT) | Experimental | Other: Sequence chemotherapy and radiotherapy (SCRT)Sequence chemotherapy and radiotherapy: 2 cycles chemotherapy of Paclitaxel and Cisplatin before and after the irradiation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with newly histologically confirmed cervical carcinoma
- Original clinical stage must be Ib~IIa （FIGO）
- Age between 18-65
- With the presence of these four factors after radical surgery:(1)positive lymph nodes,(2)positive parametria, or positive surgical margins,(3)positive lymphatic vascular space,(4)outer one-third invasion of the cervical stroma
- More than 3 months survival is to expect
Key exclusion criteria (8 listed)
- The presence of uncontrolled life-threatening illness
- Receiving other ways of anti-cancer therapy
- Residual tumor which can not be removed in the surgery
- Investigator consider the patients can't finish the whole study
- With normal liver function test (ALT、AST>2.5×ULN)
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 |
|---|---|---|
| Radiotherapy (RT)External irradiation 50Gy/5 weeks * Lateral: 2 cm lateral to the bony margin of the pelvis * Superior: Between L5 and S1 * Inferior: 2 cm below the obturator foramen Intracavitary boost 30-35Gy/4 weeks(positive vaginal margins only) | Radiation | Radiotherapy (RT) |
| Concurrent chemoirradiation (CCRT)Cisplatin 40mg/m2 every week during external irradiation | Other | Concurrent chemoirradiation (CCRT) |
| Sequence chemotherapy and radiotherapy (SCRT)Paclitaxel 135~175mg/m2 over 3 hours Cisplatin 60~75mg/m2 | Other | Sequence chemo and radiation (SCRT) |
Primary outcome
Disease Free Survival
Time frame: 3-Yr
DFS survival analysis
1 secondary outcome
Overall Survival
Time frame: 5-Yr
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2019.
- Derived from this study: PubMed 33443541Huang H, Feng YL, Wan T, Zhang YN, Cao XP, Huang YW, Xiong Y, Huang X, Zheng M, Li YF, Li JD, Chen GD, Li H, Chen YL, Ma LG, Yang HY, Li L, Yao SZ, Ye WJ, Tu H, Huang QD, Liang LZ, Liu FY, Liu Q, Liu JH. Effectiveness of Sequential Chemoradiation vs Concurrent Chemoradiation or Radiation Alone in Adjuvant Treatment After Hysterectomy for Cervical Cancer: The STARS Phase 3 Randomized Clinical Trial. JAMA Oncol. 2021 Mar 1;7(3):361-369. doi: 10.1001/jamaoncol.2020.7168.
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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.
Jihong Liu, Ph.D. study chair
Sun Yat-sen University
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 Radiotherapy (RT), Concurrent chemoirradiation (CCRT) and Sequence chemotherapy and radiotherapy (SCRT) in people with Cervical Cancer, run by Sun Yat-sen University 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 6 inclusion and 8 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 30 Jul 2019. 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.
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?
Disease Free Survival (time frame: 3-Yr). 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 NCT00806117, 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 30 Jul 2019.