Cervical CancerPhase 3NCT01755845
Trial of Postoperative Chemoradiotherapy With or Without Consolidation Chemotherapy for Cervical Cancer Patients
A Phase 3 study testing paclitaxel, cisplatin and radiotherapy in people with Cervical Cancer, run by xie congying at 1 site in China.
Trial summary
The purpose of this study is to determine the efficacy and safety of consolidation chemotherapy with paclitaxel plus cisplatin (2 cycles per 3 weeks) following radical hysterectomy and adjuvant chemoradiation (2 cycles per 4 weeks) for high risk early stage cervical cancer. 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?
- paclitaxel, cisplatin and radiotherapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- Jan 2011to Dec 2016
- 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 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Undertaken radical hysterectomy with diagnosis of invasive cervical cancer I a2-II b (non-small cell type)
- One or more risk factors (lymph node involvement, resection margin involvement, parametrial involvement)
- Eastern Cooperative Oncology Group 0-2
- Expected life span over 6 months.
- No distant metastasis
- Adequate bone marrow functions (absolute neutrophil count≥ 1,500/ul, blood platelet≥ 100,000/ul, haemoglobin≥ 10g/dl)
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- Adequate renal functions(serum creatinine ≤ 1.5mg/dl)
- Adequate liver functions (serum bilirubin ≤ 1.5mg/dl, aspartate aminotransferase/alanine aminotransferase ≤ 3 times(normal value)
- Written informed consent
Who cannot join
- Previous history of chemotherapy or radiation
- Hypersensitive reaction to platinum/paclitaxel agent
- History of other cancer
- Concurrent systemic illness not appropriate for chemotherapy
- Active infection requiring antibiotics
- Pregnancy
- Metastasis to paraaortic lymph node
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Wenzhou Medical College
Wenzhou, Zhejiang, 325000
congying xie, +86-577-88069316, wzxiecongying@163.com
congying xie, MD
About this study
Official title: Phase III Randomized Study of Concurrent Paclitaxel/Cisplatin Chemotherapy and Radiotherapy With or Without Consolidation Chemotherapy in High-Risk Patients With Early-Stage Cervical Cancer Following Radical Hysterectomy
The purpose of this study is to determine the efficacy and safety of consolidation chemotherapy with paclitaxel plus cisplatin (2 cycles per 3 weeks) following radical hysterectomy and adjuvant chemoradiation (2 cycles per 4 weeks) for high risk early stage cervical cancer.
Read the detailed description
Cervical carcinoma is one of the most common gynecologic cancers worldwide. Early stage cervical cancer can be treated effectively with either radiotherapy or radical hysterectomy plus pelvic lymph node dissection. However, several pathological risk factors, such as lymph node metastasis, the involvement of vaginal resection margin, and the parametrial invasion, have been identified to compromise the patient prognosis.
Concurrent radiotherapy with cisplatin-based chemotherapy has become the standard treatment for patients with cervical cancer. However, many patients with pathological risk factors treated with concurrent radiotherapy plus single agent cisplatin still suffered from the local or distant relapse. How to improve the treatment outcome of these patients is a very important issue and requires further clinical investigation.
Paclitaxel has been demonstrated to be a good radiosensitizer. In addition, paclitaxel/cisplatin combination chemotherapy was demonstrated to have superior progression-free survival than platinum alone in some phase Ⅱ studies. In addition, it is not yet known whether chemotherapy and radiation therapy are more effective when given with consolidation chemotherapy in treating cervical cancer.
Therefore, the investigators are going to perform the efficacy and safety study of postoperative concurrent paclitaxel/cisplatin chemotherapy and radiotherapy with consolidation chemotherapy in high-risk patients with early-stage cervical cancer following radical hysterectomy.
- Conditions
- Cervical Cancer
- Being tested
- paclitaxel, cisplatin, radiotherapy
- Keywords
- cervical cancer, radiotherapy, postoperative therapy, chemotherapy
- 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.
paclitaxelDrug
cisplatinDrug
radiotherapyRadiation
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Patients in this arm will postoperatively receive paclitaxel 135 mg/m2 d1 and cisplatin 25mg/m2 d1-3 intravenously every 4 weeks with radiation. Radiotherapy consisted of 46-50 gray (5 x 2.0 gray/week) on pelvic area. After completion of chemoradiotherapy, patients receive paclitaxel 135 mg/m2 d1 and cisplatin 25mg/m2 d1-3. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Receives: Drug: paclitaxel; Drug: cisplatin; Radiation: radiotherapy |
| Arm 2 | Active comparator | Patients receive chemoradiotherapy as in arm 1. Receives: Drug: paclitaxel; Drug: cisplatin; Radiation: radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
disease-free survival
Measured: 3 years
Secondary outcomes (1)
overall survival
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 posted24 Dec 2012 (estimated)
- Study startJan 2011
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- xie congying
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, xie congying, Wenzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01755845
- Sponsor's protocol ID
- WZMC-11256
- Status last verified
- Apr 2016
- First submitted
- 19 Dec 2012
- Last updated
- 28 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Randomized Study of Concurrent Paclitaxel/Cisplatin Chemotherapy and Radiotherapy With or Without Consolidation Chemotherapy in High-Risk Patients With Early-Stage Cervical Cancer Following Radical Hysterectomy
- ClinicalTrials.gov ID
- NCT01755845
- Acronym / sponsor ID
- WZMC-11256
- Conditions
- Cervical Cancer
- Keywords
- cervical cancer, radiotherapy, postoperative therapy, chemotherapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- xie congyingUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 24 Dec 2012 (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 purpose of this study is to determine the efficacy and safety of consolidation chemotherapy with paclitaxel plus cisplatin (2 cycles per 3 weeks) following radical hysterectomy and adjuvant chemoradiation (2 cycles per 4 weeks) for high risk early stage cervical cancer.
Detailed description
Cervical carcinoma is one of the most common gynecologic cancers worldwide. Early stage cervical cancer can be treated effectively with either radiotherapy or radical hysterectomy plus pelvic lymph node dissection. However, several pathological risk factors, such as lymph node metastasis, the involvement of vaginal resection margin, and the parametrial invasion, have been identified to compromise the patient prognosis.
Concurrent radiotherapy with cisplatin-based chemotherapy has become the standard treatment for patients with cervical cancer. However, many patients with pathological risk factors treated with concurrent radiotherapy plus single agent cisplatin still suffered from the local or distant relapse. How to improve the treatment outcome of these patients is a very important issue and requires further clinical investigation.
Paclitaxel has been demonstrated to be a good radiosensitizer. In addition, paclitaxel/cisplatin combination chemotherapy was demonstrated to have superior progression-free survival than platinum alone in some phase Ⅱ studies. In addition, it is not yet known whether chemotherapy and radiation therapy are more effective when given with consolidation chemotherapy in treating cervical cancer.
Therefore, the investigators are going to perform the efficacy and safety study of postoperative concurrent paclitaxel/cisplatin chemotherapy and radiotherapy with consolidation chemotherapy in high-risk patients with early-stage cervical cancer following radical hysterectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: paclitaxel, Drug: cisplatin, Radiation: radiotherapyPatients in this arm will postoperatively receive paclitaxel 135 mg/m2 d1 and cisplatin 25mg/m2 d1-3 intravenously every 4 weeks with radiation. Radiotherapy consisted of 46-50 gray (5 x 2.0 gray/week) on pelvic area. After completion of chemoradiotherapy, patients receive paclitaxel 135 mg/m2 d1 and cisplatin 25mg/m2 d1-3. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. |
| Arm 2 | Active comparator | Drug: paclitaxel, Drug: cisplatin, Radiation: radiotherapyPatients receive chemoradiotherapy as in arm 1. |
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)
- Undertaken radical hysterectomy with diagnosis of invasive cervical cancer I a2-II b (non-small cell type)
- One or more risk factors (lymph node involvement, resection margin involvement, parametrial involvement)
- Eastern Cooperative Oncology Group 0-2
- Expected life span over 6 months.
- No distant metastasis
Key exclusion criteria (7 listed)
- Previous history of chemotherapy or radiation
- Hypersensitive reaction to platinum/paclitaxel agent
- History of other cancer
- Concurrent systemic illness not appropriate for chemotherapy
- Active infection requiring antibiotics
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 |
|---|---|---|
| paclitaxel | Drug | Arm 1, Arm 2 |
| cisplatin | Drug | Arm 1, Arm 2 |
| radiotherapy | Radiation | Arm 1, Arm 2 |
Primary outcome
disease-free survival
Time frame: 3 years
1 secondary outcome
overall survival
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 28 Apr 2016.
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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.
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 paclitaxel, cisplatin and radiotherapy in people with Cervical Cancer, run by xie congying 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 9 inclusion and 7 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 28 Apr 2016. 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?
Contact congying xie, MD (+86-577-88069316, wzxiecongying@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
disease-free survival (time frame: 3 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 28 Apr 2016.