Cervical CancerPhase 2/3NCT01999933
Evaluation of Postoperative Radiotherapy and Concurrent Chemotherapy Effectiveness in Cervical Cancer
A Phase 2/3 study testing Radiation, cisplatin（DDP） weekly and docetaxel plus cisplatin in people with Cervical Cancer and Toxicity Due to Radiotherapy, run by Mei Shi at 1 site in China.
Trial summary
The present study is a randomized, control, phase II/III study of early stage (FIGO Ia2-IIb) cervical cancer after radical hysterectomy in Northwest China treated with radiotherapy or concurrent chemoradiotherapy based on the surgical-pathological risk factors. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Cervical Cancer, Toxicity Due to Radiotherapy
- What is being tested?
- Radiation, cisplatin（DDP） weekly and docetaxel plus cisplatin
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteChina
- Study dates
- Nov 2013to Nov 2018
- Phase
- Phase 2/3
- 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 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 Years to 70 Years
- Histologically proven cervical cancer, FIGO stage Ia2-IIb,and no previous chemotherapy and radiotherapy
- Accepted radical hysterectomy 3-4 weeks before
- Karnofsky score >70
- Postoperative pathology with following risk factors: Non-squamous cell carcinoma, deep stromal invasion, lymphovascular space invasion, marginal positive, parametria invasion, large tumor size (tumor diameter>4cm) or pelvic LN metastasis. Patients with pelvic LN metastasis and combination of any two or more risk factors mentioned above were included.
- Examination results showed no radiation or chemotherapy contraindication
- Willing to accept treatment
- Ability to comply with trial requirements
Who cannot join
- Postoperative residual
- Postoperative recurrence or metastasis
- Without lymph node dissection
- Postoperative pathology showed aortic lymph node metastasis
- Examination results showed radiotherapy contraindications
- No indications for radiotherapy
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Radiation Oncology, Xijing Hospital, Fourth Military Medical University
Xi'an, Shaanxi, 710032
Mei Shi, MD, +86-029-84775425, mshifmmu@yahoo.com
Mei Shi, MD
About this study
Official title: Clinical Study on Docetaxel Plus Cisplatin(TP) Regimen Combined With Postoperative Radiotherapy for Stage Ia2- IIb Cervical Cancer
The present study is a randomized, control, phase II/III study of early stage (FIGO Ia2-IIb) cervical cancer after radical hysterectomy in Northwest China treated with radiotherapy or concurrent chemoradiotherapy based on the surgical-pathological risk factors. All the patients received whole pelvis radiation and were divided into three groups according to adjuvant chemotherapy: concurrent chemotherapy with cisplatin weekly (40mg/m2) , concurrent chemotherapy with docetaxel plus cisplatin tri-weekly (75mg/m2), or concurrent and adjuvant chemotherapy with docetaxel plus cisplatin tri-weekly (75mg/m2). The effectiveness, and side effects will be evaluated according to Standard WHO response criteria, and NCI common toxicity criteria for adverse events(NCI-CTC-AE) V3.0.
Read the detailed description
To the cervical cancer patient who accepted radical hysterectomy, whether the adjuvant therapy should be received or the method of adjuvant therapy are determined by the postoperative pathology. In the traditional opinion, the postoperative risk factors were divided into two groups: intermediate risk factors, including large tumor size, deep stromal invasion and lymphovascular space invasion, and high risk factors, including non-squamous cell carcinoma, marginal positive, parametric invasion and pelvic lymph node(LN) metastasis. Patients with intermediate risk factors should accepted adjuvant radiotherapy only and who with high risk factors should received adjuvant concurrent chemoradiotherapy. Cisplatin weekly(40mg/m2) was the standard regimen of concurrent chemotherapy. However, we retrospectively analyzed 801 cervical cancer patients with postoperative radiotherapy and found that distant metastasis was the main cause of current treatment failure(84.5%), which suggested the current regimen of chemotherapy was insufficient and might be strengthened in future.
- Conditions
- Cervical Cancer, Toxicity Due to Radiotherapy
- Being tested
- Radiation, cisplatin（DDP） weekly, docetaxel plus cisplatin
- Keywords
- Cervical cancer, postoperative risk factor, treatment
- 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.
RadiationRadiation
Arm1, Arm2 and Arm3 patients should received the whole pelvic radiation.
cisplatin（DDP） weeklyDrug
concurrent chemotherapy with cisplatin（DDP） weekly(40mg/m2),begin with radiation
docetaxel plus cisplatinDrug
concurrent docetaxel plus cisplatin tri-weekly (75mg/m2),2 cycles, begin with radiation
docetaxel plus cisplatinDrug
adjuvant chemotherapy with docetaxel plus cisplatin tri-weekly (75mg/m2), 4 cycles after radiation
| Study group | Role | What they receive |
|---|---|---|
| CCRT with cisplatin(DDP) weekly | Active comparator | concurrent chemotherapy: cisplatin（DDP） weekly, 40mg/m2, begin with radiation Receives: Radiation: Radiation; Drug: cisplatin（DDP） weekly |
| CCRT with TP | Experimental | concurrent TP tri-weekly, docetaxel plus cisplatin tri-weekly (75mg/m2), begin with radiation Receives: Radiation: Radiation; Drug: docetaxel plus cisplatin |
| concurrent and adjuvant TP | Experimental | 2 cycles of concurrent TP, docetaxel plus cisplatin tri-weekly (75mg/m2),begin with radiation; and 4 cycles of adjuvant TP, the same regimen, after radiation Receives: Radiation: Radiation; Drug: docetaxel plus cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival
Measured: 5-years
Secondary outcomes (3)
disease-free survival
Measured: 5 years
acute adverse events
Measured: 3 months
chronic adverse events
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2013 (estimated)
- Study startNov 2013
- Primary completionNov 2016 (estimated)
- Study completionNov 2018 (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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mei Shi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mei Shi, Air Force Military Medical University, China
- Investigators
- Mei Shi, MD, Principal investigator, department of radiation oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01999933
- Sponsor's protocol ID
- XJFL-201309-CCPOSTOP
- Status last verified
- Nov 2013
- First submitted
- 26 Nov 2013
- Last updated
- 3 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on Docetaxel Plus Cisplatin(TP) Regimen Combined With Postoperative Radiotherapy for Stage Ia2- IIb Cervical Cancer
- ClinicalTrials.gov ID
- NCT01999933
- Acronym / sponsor ID
- XJFL-201309-CCPOSTOP
- Conditions
- Cervical Cancer, Toxicity Due to Radiotherapy
- Keywords
- Cervical cancer, postoperative risk factor, treatment
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Mei ShiUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Nov 2016 (estimated)
- Study completion
- Nov 2018 (estimated)
- First posted
- 3 Dec 2013 (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 present study is a randomized, control, phase II/III study of early stage (FIGO Ia2-IIb) cervical cancer after radical hysterectomy in Northwest China treated with radiotherapy or concurrent chemoradiotherapy based on the surgical-pathological risk factors. All the patients received whole pelvis radiation and were divided into three groups according to adjuvant chemotherapy: concurrent chemotherapy with cisplatin weekly (40mg/m2) , concurrent chemotherapy with docetaxel plus cisplatin tri-weekly (75mg/m2), or concurrent and adjuvant chemotherapy with docetaxel plus cisplatin tri-weekly (75mg/m2). The effectiveness, and side effects will be evaluated according to Standard WHO response criteria, and NCI common toxicity criteria for adverse events(NCI-CTC-AE) V3.0.
Detailed description
To the cervical cancer patient who accepted radical hysterectomy, whether the adjuvant therapy should be received or the method of adjuvant therapy are determined by the postoperative pathology. In the traditional opinion, the postoperative risk factors were divided into two groups: intermediate risk factors, including large tumor size, deep stromal invasion and lymphovascular space invasion, and high risk factors, including non-squamous cell carcinoma, marginal positive, parametric invasion and pelvic lymph node(LN) metastasis. Patients with intermediate risk factors should accepted adjuvant radiotherapy only and who with high risk factors should received adjuvant concurrent chemoradiotherapy. Cisplatin weekly(40mg/m2) was the standard regimen of concurrent chemotherapy. However, we retrospectively analyzed 801 cervical cancer patients with postoperative radiotherapy and found that distant metastasis was the main cause of current treatment failure(84.5%), which suggested the current regimen of chemotherapy was insufficient and might be strengthened in future.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CCRT with cisplatin(DDP) weekly | Active comparator | Radiation: Radiation, Drug: cisplatin（DDP） weeklyconcurrent chemotherapy: cisplatin（DDP） weekly, 40mg/m2, begin with radiation |
| CCRT with TP | Experimental | Radiation: Radiation, Drug: docetaxel plus cisplatinconcurrent TP tri-weekly, docetaxel plus cisplatin tri-weekly (75mg/m2), begin with radiation |
| concurrent and adjuvant TP | Experimental | Radiation: Radiation, Drug: docetaxel plus cisplatin2 cycles of concurrent TP, docetaxel plus cisplatin tri-weekly (75mg/m2),begin with radiation; and 4 cycles of adjuvant TP, the same regimen, after radiation |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 18 Years to 70 Years
- Histologically proven cervical cancer, FIGO stage Ia2-IIb,and no previous chemotherapy and radiotherapy
- Accepted radical hysterectomy 3-4 weeks before
- Karnofsky score >70
- Postoperative pathology with following risk factors: Non-squamous cell carcinoma, deep stromal invasion, lymphovascular space invasion, marginal positive, parametria invasion, large tumor size (tumor diameter>4cm) or pelvic LN metastasis. Patients with pelvic LN metastasis and combination of any two or more risk factors mentioned above were included.
Key exclusion criteria (6 listed)
- Postoperative residual
- Postoperative recurrence or metastasis
- Without lymph node dissection
- Postoperative pathology showed aortic lymph node metastasis
- Examination results showed radiotherapy contraindications
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 |
|---|---|---|
| RadiationArm1, Arm2 and Arm3 patients should received the whole pelvic radiation. | Radiation | CCRT with TP, CCRT with cisplatin(DDP) weekly, concurrent and adjuvant TP |
| cisplatin（DDP） weeklyconcurrent chemotherapy with cisplatin（DDP） weekly(40mg/m2),begin with radiation | Drug | CCRT with cisplatin(DDP) weekly |
| docetaxel plus cisplatinconcurrent docetaxel plus cisplatin tri-weekly (75mg/m2),2 cycles, begin with radiation | Drug | CCRT with TP, concurrent and adjuvant TP |
| docetaxel plus cisplatinadjuvant chemotherapy with docetaxel plus cisplatin tri-weekly (75mg/m2), 4 cycles after radiation | Drug | concurrent and adjuvant TP |
Primary outcome
overall survival
Time frame: 5-years
3 secondary outcomes
disease-free survival
Time frame: 5 years
acute adverse events
Time frame: 3 months
chronic adverse events
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2013.
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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.
Mei Shi, MD principal investigator
department of radiation oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Radiation, cisplatin（DDP） weekly and docetaxel plus cisplatin in people with Cervical Cancer and Toxicity Due to Radiotherapy, run by Mei Shi 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 8 inclusion and 6 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 3 Dec 2013. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Contact Mei Shi, MD.PhD (+86-029-84775425, mshifmmu@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall survival (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 3 Dec 2013.