Cervical CancerPhase 2NCT02835404
Pelvic External Combined With 252-Cf Neutron Intracavitary Radiotherapy With or Without Platinum in Treating Advanced Cervical Cancer
A Phase 2 study testing Nedaplatin, Pelvic External Radiotherapy and 252-Cf Neutron Intracavitary Brachytherapy in people with Cervical Cancer and Complications, run by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University at 1 site in China.
Trial summary
The objective of this study was to evaluate the efficacy and complication of the treatment of pelvic external combined with 252-Cf neutron intracavitary radiotherapy with or without platinum in local advanced cervical cancer patients in the short and long term. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Cervical Cancer, Complications
- What is being tested?
- Nedaplatin, Pelvic External Radiotherapy and 252-Cf Neutron Intracavitary Brachytherapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Nov 2012to Nov 2018
- Phase
- Phase 2
- 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
- 1. To be aged from 18 (including 18) to 65 (including 65), female patient;
- 2. Expected survival ≥6 months
- 3. Pathologically proven diagnosis of squamous carcinoma or adenocarcinoma of the cervix, according to FIGO(International Federation of Gynecology and Obstetrics) staging, appropriate stage for protocol entry, including IIA2, IIB,IIIA,IIIB;
- 4. No patients with distant metastases;
- 5. Measurable target lesions (satisfying the criteria in RECIST 1.1);
- 6. ECOG PS status of 0-2;
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- 7. No prior treatment;
- 8. No
- 9. No surgery
- 10. Major organ function has to meet the following criteria:
- Bilirubin <1.5 times the upper limit of normal (ULN)
- ALT , AST and APL≤2.5 × ULN
- NEUT≥2.0 × 10^9 / L
- PLT ≥ 100 × 10^9 / L
- HB≥60g/L
- Serum Cr and urea nitrogen ≤ 1.5 × ULN
- 11. Favorable cardiac functions, no patients with myocardial infarction within half a year, hypertension and coronary disease are well-controlled.
Who cannot join
- 1. Serious heart disease, pulmonary disease, hepatic disease, , renal disease and metabolic disease, or with electrolyte disturbance;
- 2. Allergic to platinum;
- 3. Rejecte to join the study in other conditions.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Chongqing
Xin Lei, M.D
About this study
Official title: A Randomized, Open Label, Single Centre Clinical Trial of Pelvic External Radiotherapy Combined With 252-Cf Neutron Intracavitary Brachytherapy With or Without Platinum in Treatment of Local Advanced Cervical Cancer
The objective of this study was to evaluate the efficacy and complication of the treatment of pelvic external combined with 252-Cf neutron intracavitary radiotherapy with or without platinum in local advanced cervical cancer patients in the short and long term.
- Conditions
- Cervical Cancer, Complications
- Being tested
- Nedaplatin, Pelvic External Radiotherapy, 252-Cf Neutron Intracavitary Brachytherapy
- 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.
NedaplatinDrug
Also called NDP
Chemotherapy: Nedaplatin(NDP) 30-40mg/m2 iv., on day1, 4weeks as one cycle
Pelvic External RadiotherapyRadiation
patients received 20 Gy2.0/f, for 25-27f (SSD)with 8mv-X rays (SSD)
252-Cf Neutron Intracavitary BrachytherapyRadiation
total dose of reference point A was 4400cGy, in four times Transvaginal implant sessions during Pelvic External Radiations
| Study group | Role | What they receive |
|---|---|---|
| Concurrent radiochemotherapy Group | Experimental | Concurrent radiochemotherapy with Nedaplatin Pelvic External Radiotherapy: patients received 20 Gy2.0/f, for 25-27f with 8mv-X rays (SSD) 252-Cf Neutron Intracavitary Brachytherapy: total dose of reference point A was 4400cGy, in four times Transvaginal implant sessions during Pelvic External Radiations; Chemotherapy: Nedaplatin(NDP) 30-40mg/m2 iv., on day1, 4weeks as one cycle Receives: Drug: Nedaplatin; Radiation: Pelvic External Radiotherapy; Radiation: 252-Cf Neutron Intracavitary Brachytherapy |
| Radiotherapy Group | Active comparator | patients received Radiotherapy only Pelvic External Radiotherapy: patients received 20 Gy2.0/f, for 25-27f (SSD)with 8mv-X Linear Accelerator SSD 252-Cf Neutron Intracavitary Brachytherapy: total dose of reference point A was 4400cGy, in four times Transvaginal implant sessions during Pelvic External Radiations. Receives: Radiation: Pelvic External Radiotherapy; Radiation: 252-Cf Neutron Intracavitary Brachytherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute toxicity events
chemo-related toxicity as measured by CTCAE v. 4.0, radiation-related toxicity as measured by RTOG/EORTC criteria
Measured: Week 5 of Radiation Therapy (RT)
Long-trem toxicity events
chemo-related toxicity as measured by CTCAE v. 4.0, radiation-related toxicity as measured by RTOG/EORTC criteria
Measured: through study completion, an average of 5 year
Secondary outcomes (5)
2 Years Overall survial Rate
chemo-related toxicity as measured by CTCAE v. 4.0, radiation-related toxicity
Measured: 2 years
3 Years Overall survial Rate
Measured: 3 years
5 Years Overall survial Rate
Measured: 5 years
Disease-free survival (DFS)
Measured: through study completion, an average of 3 year
Overall survial (OS)
Measured: through study completion, an average of 5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2016 (estimated)
- Study startNov 2012
- Primary completionJun 2017 (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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xin Lei, M.D.Prof, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
- Investigators
- Xin Lei, M.D, Principal investigator, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02835404
- Sponsor's protocol ID
- 2012012
- Status last verified
- Jun 2016
- First submitted
- 6 Jul 2016
- Last updated
- 18 Jul 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open Label, Single Centre Clinical Trial of Pelvic External Radiotherapy Combined With 252-Cf Neutron Intracavitary Brachytherapy With or Without Platinum in Treatment of Local Advanced Cervical Cancer
- ClinicalTrials.gov ID
- NCT02835404
- Acronym / sponsor ID
- 2012012
- Conditions
- Cervical Cancer, Complications
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical UniversityUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Nov 2018 (estimated)
- First posted
- 18 Jul 2016 (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 was to evaluate the efficacy and complication of the treatment of pelvic external combined with 252-Cf neutron intracavitary radiotherapy with or without platinum in local advanced cervical cancer patients in the short and long term.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Concurrent radiochemotherapy Group | Experimental | Drug: Nedaplatin, Radiation: Pelvic External Radiotherapy, Radiation: 252-Cf Neutron Intracavitary BrachytherapyConcurrent radiochemotherapy with Nedaplatin Pelvic External Radiotherapy: patients received 20 Gy2.0/f, for 25-27f with 8mv-X rays (SSD) 252-Cf Neutron Intracavitary Brachytherapy: total dose of reference point A was 4400cGy, in four times Transvaginal implant sessions during Pelvic External Radiations; Chemotherapy: Nedaplatin(NDP) 30-40mg/m2 iv., on day1, 4weeks as one cycle |
| Radiotherapy Group | Active comparator | Radiation: Pelvic External Radiotherapy, Radiation: 252-Cf Neutron Intracavitary Brachytherapypatients received Radiotherapy only Pelvic External Radiotherapy: patients received 20 Gy2.0/f, for 25-27f (SSD)with 8mv-X Linear Accelerator SSD 252-Cf Neutron Intracavitary Brachytherapy: total dose of reference point A was 4400cGy, in four times Transvaginal implant sessions during Pelvic External Radiations. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 1. To be aged from 18 (including 18) to 65 (including 65), female patient;
- 2. Expected survival ≥6 months
- 3. Pathologically proven diagnosis of squamous carcinoma or adenocarcinoma of the cervix, according to FIGO(International Federation of Gynecology and Obstetrics) staging, appropriate stage for protocol entry, including IIA2, IIB,IIIA,IIIB;
- 4. No patients with distant metastases;
- 5. Measurable target lesions (satisfying the criteria in RECIST 1.1);
Key exclusion criteria (3 listed)
- 1. Serious heart disease, pulmonary disease, hepatic disease, , renal disease and metabolic disease, or with electrolyte disturbance;
- 2. Allergic to platinum;
- 3. Rejecte to join the study in other conditions.
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 |
|---|---|---|
| NedaplatinAlso: NDPChemotherapy: Nedaplatin(NDP) 30-40mg/m2 iv., on day1, 4weeks as one cycle | Drug | Concurrent radiochemotherapy Group |
| Pelvic External Radiotherapypatients received 20 Gy2.0/f, for 25-27f (SSD)with 8mv-X rays (SSD) | Radiation | Concurrent radiochemotherapy Group, Radiotherapy Group |
| 252-Cf Neutron Intracavitary Brachytherapytotal dose of reference point A was 4400cGy, in four times Transvaginal implant sessions during Pelvic External Radiations | Radiation | Concurrent radiochemotherapy Group, Radiotherapy Group |
Primary outcome
Acute toxicity events
Time frame: Week 5 of Radiation Therapy (RT)
chemo-related toxicity as measured by CTCAE v. 4.0, radiation-related toxicity as measured by RTOG/EORTC criteria
Long-trem toxicity events
Time frame: through study completion, an average of 5 year
chemo-related toxicity as measured by CTCAE v. 4.0, radiation-related toxicity as measured by RTOG/EORTC criteria
5 secondary outcomes
2 Years Overall survial Rate
Time frame: 2 years
3 Years Overall survial Rate
Time frame: 3 years
5 Years Overall survial Rate
Time frame: 5 years
Disease-free survival (DFS)
Time frame: through study completion, an average of 3 year
Overall survial (OS)
Time frame: through study completion, an average of 5 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 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.
Xin Lei, M.D principal investigator
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nedaplatin, Pelvic External Radiotherapy and 252-Cf Neutron Intracavitary Brachytherapy in people with Cervical Cancer and Complications, run by Daping Hospital and the Research Institute of Surgery of the Third Military Medical 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 17 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 18 Jul 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Xin Lei, M.D (+86 023-68757176, dpxinlei@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute toxicity events (time frame: Week 5 of Radiation Therapy (RT)). The study lists 2 primary outcomes in all. 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 18 Jul 2016.