Cervical CancerPhase 3NCT02703961
Randomized Control Trial on Efficacy and Safety of Concurrent and Adjuvant Chemotherapy for the Cervical Cancer
A Phase 3 study testing concurrent chemotherapy with cisplatin, concurrent chemotherapy with docetaxel and pelvic radiotherapy in people with Cervical Cancer, run by Air Force Military Medical University, China at 3 sites in China.
Trial summary
The standard treatment of local advanced cervical cancer is concurrent chemoradiotherapy. The 3 year disease free survival was about 50-70%. The distant metastasis is the main cause of failure in local advanced cervical cancer treated with 3-dimensional conformal radiotherapy (3D-CRT) or intensity modulated… Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- concurrent chemotherapy with cisplatin, concurrent chemotherapy with docetaxel and pelvic radiotherapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 598 participants
- Where
- 3 sitesChina
- Study dates
- Feb 2016to Feb 2021
- 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 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Biopsy-proven, invasive squamous cell carcinoma, adenocarcinoma, or adenosquamouscarcinoma of the cervix
- FIGO clinical stage IB2-IIB with pelvic lymph node metastasis or FIGO clinical stage III-IVA with or without pelvic lymph node metastasis
- ECOG performance score 0-1
- The bone marrow, hepatic and renal function was normal at registration
- The patients signed informed consent
Who cannot join
- clear cell and small cell neuroendocrine, sarcoma
- FIGO stage IVB
- Prior invasive malignancy
- Prior systemic chemotherapy
- Prior radiotherapy to the pelvis or abdomen
- Severe, active co-morbidity
- Women who are pregnant
- immunocompromised status
Trial locations and contacts
3 sites in 1 country.
China3 sites, 3 recruiting
- Recruiting
Xijing hospital, the Fourth Military Medical University
Xi'an, Shaanxi, 710032
Mei Shi, professor, 0086-029-84775432, mshi82@fmmu.edu.cn
ying zhang, doctor, 0086-029-84775432, zhangying@fmmu.edu.cn
- Recruiting
Department of Radiation Oncology, Xijing Hospital, Fourth Military Medical University
Xi’an, Shanxi, 710032
Mei Shi, MM, +86-029-84775425, mshi82@fmmu.edu.cn
Mei Shi, MM
- Recruiting
Department of Radiation Oncology, Xijing Hospital, Fourth Military
Xi’an, Shanxi, 710032
Mei Shi, MD, 86-29-84775425, Shimei82@gmail.com
About this study
Official title: Multicenter Study on Efficacy and Safety of Concurrent and Adjuvant Chemotherapy With Cisplatin and Docetaxel Combined With Radiotherapy for Local Advanced Cervical Cancer
The standard treatment of local advanced cervical cancer is concurrent chemoradiotherapy. The 3 year disease free survival was about 50-70%. The distant metastasis is the main cause of failure in local advanced cervical cancer treated with 3-dimensional conformal radiotherapy (3D-CRT) or intensity modulated radiotherapy (IMRT). The purpose of this study is to investigate the efficacy and tolerance of concurrent and adjuvant chemotherapy with cisplatin and docetaxel for local advanced cervical cancer. It was expected that the 3 year disease free survival would be increased by 10% with this new treatment schedule.
Read the detailed description
The cervical cancer is the most common malignant gynecological tumor in the developing area. From 1999, the concurrent chemoradiotherapy has been established as the standard treatment for local advanced cervical cancer. The modern radiotherapy techniques, such as 3 dimensional conformal radiotherapy(3D-CRT), intensity modulated radiotherapy(IMRT), image guided 3-dimensional brachytherapy(3D-BT), was widely used for the treatment of cervical cancer. The recently clinical outcome showed that the 3 year local and regional control was more than 90%［1-3］. The distant metastasis has proved to be the main cause of failure and death, especially for the patient with pelvic lymph node metastasis, large volume of tumor and advanced FIGO stage. the data showed that the 3 year distant metastasis free survival and overall survival were 64.7% and 64.6% respectively for the patient with huge pelvic lymph node metastasis and FIGO stage III- IVA. The system treatment pointing at the distant metastasis has become to be the topic of clinical investigation.
Dueñas-González A'［4］ study demonstrated that the 3 year progress free survival and distant metastasis free survival has increased by 8.9% and 8.3% by the radial radiotherapy combined with concurrent chemotherapy with weekly gemcitabine and cisplatin and adjuvant chemotherapy with triweekly gemcitabine and cisplatin. Ryu SY［5］ also reported the triweekly concurrent cisplatin with 3 cycles improved survival outcomes compared with weekly concurrent cisplatin. Retrospective studies by Tang and Jelavić-TB［6-7］ suggested that the adjubant chemotherapy after CCRT has better DMFS and OS.
The aim of present study is to prospectively investigate the efficacy and safety of concurrent and adjuvant chemotherapy with cisplatin and docetaxel for patients with local advanced cervical cancer, especially for those with FIGO III-IVA with or without pelvic lymph node metastasis and the FIGO IB2-IIB with pelvic lymph node metastasis.
- Conditions
- Cervical Cancer
- Being tested
- concurrent chemotherapy with cisplatin, concurrent chemotherapy with docetaxel, pelvic radiotherapy, brachytherapy, adjuvant chemotherapy with cisplatin and docetaxel
- Keywords
- CCRT, adjuvant chemotherapy, cisplatin and docetaxel
- 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.
concurrent chemotherapy with cisplatinDrug
Also called cisplatin
in experimental group: cisplatin 60mg/m2, d1,d22;
concurrent chemotherapy with docetaxelDrug
Also called docetaxel
in experimental group: docetaxel 60mg/m2, d1,d22;
pelvic radiotherapyRadiation
Also called external beam radiotherapy
external beam radiotherapy for whole pelvix with 50Gy/25f boost radiotherapy for pelvic lymph node metastasis with 12-14Gy/4-7f.
brachytherapyRadiation
CT/MRI guided brachytherapy or x-ray guided brachytherapy
adjuvant chemotherapy with cisplatin and docetaxelDrug
cisplatin 75mg/m2, d43,d64; docetaxel 75mg/m2, d43,d64
| Study group | Role | What they receive |
|---|---|---|
| experimental | Experimental | concurrent and adjuvant chemotherapy with cisplatin and docetaxel combined radical radiotherapy.
During external beam radiotherapy: cisplatin 60mg/m2, d1,d22; docetaxel 60mg/m2, d1,d22.
After external beam radiotherapy: cisplatin 75mg/m2, d43,d64;
The patients also undergo external-beam radiation therapy once daily, 5 days a week, for approximately 5 weeks. Patients then undergo high-dose rate intracavitary brachytherapy.
docetaxel 75mg/m2, d43,d64. Receives: Drug: concurrent chemotherapy with cisplatin; Drug: concurrent chemotherapy with docetaxel; Radiation: pelvic radiotherapy; Radiation: brachytherapy; Drug: adjuvant chemotherapy with cisplatin and docetaxel |
| control | Other | standard chemoradiotherapy with weekly cisplatin.
Patients receive cisplatin IV over 60-90 minutes on days 1, 8, 15, 22, and 29.
Patients also undergo external-beam radiation therapy once daily, 5 days a week, for approximately 5 weeks. Patients then undergo high-dose rate intracavitary brachytherapy. Receives: Drug: concurrent chemotherapy with cisplatin; Radiation: pelvic radiotherapy; Radiation: brachytherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
disease free survival
Measured: 3 year
Secondary outcomes (1)
overall survival
Measured: 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2016 (estimated)
- Study startFeb 2016
- Primary completionFeb 2018 (estimated)
- Study completionFeb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- 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
- None (open label)
- Enrolment
- 598 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Air Force Military Medical University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mei Shi, Air Force Military Medical University, China
- Investigators
- mei shi, professor, Principal investigator, Xijing Hospital, the Fourth Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02703961
- Sponsor's protocol ID
- XJFL-2016-02-LACC-TP triweekly
- Status last verified
- Mar 2016
- First submitted
- 3 Mar 2016
- Last updated
- 17 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
Jelavic TB, Mise BP, Strikic A, Ban M, Vrdoljak E. Adjuvant Chemotherapy in Locally Advanced Cervical Cancer After Treatment with Concomitant Chemoradiotherapy--Room for Improvement? Anticancer Res. 2015 Jul;35(7):4161-5.
PubMed 26124372Tharavichitkul E, Chakrabandhu S, Wanwilairat S, Tippanya D, Nobnop W, Pukanhaphan N, Galalae RM, Chitapanarux I. Intermediate-term results of image-guided brachytherapy and high-technology external beam radiotherapy in cervical cancer: Chiang Mai University experience. Gynecol Oncol. 2013 Jul;130(1):81-5. doi: 10.1016/j.ygyno.2013.04.018. Epub 2013 Apr 17.
PubMed 23603369Gill BS, Kim H, Houser CJ, Kelley JL, Sukumvanich P, Edwards RP, Comerci JT, Olawaiye AB, Huang M, Courtney-Brooks M, Beriwal S. MRI-guided high-dose-rate intracavitary brachytherapy for treatment of cervical cancer: the University of Pittsburgh experience. Int J Radiat Oncol Biol Phys. 2015 Mar 1;91(3):540-7. doi: 10.1016/j.ijrobp.2014.10.053. Epub 2015 Jan 30.
PubMed 25680598Tinkle CL, Weinberg V, Chen LM, Littell R, Cunha JAM, Sethi RA, Chan JK, Hsu IC. Inverse Planned High-Dose-Rate Brachytherapy for Locoregionally Advanced Cervical Cancer: 4-Year Outcomes. Int J Radiat Oncol Biol Phys. 2015 Aug 1;92(5):1093-1100. doi: 10.1016/j.ijrobp.2015.04.018. Epub 2015 Jul 14.
PubMed 26194683Duenas-Gonzalez A, Zarba JJ, Patel F, Alcedo JC, Beslija S, Casanova L, Pattaranutaporn P, Hameed S, Blair JM, Barraclough H, Orlando M. Phase III, open-label, randomized study comparing concurrent gemcitabine plus cisplatin and radiation followed by adjuvant gemcitabine and cisplatin versus concurrent cisplatin and radiation in patients with stage IIB to IVA carcinoma of the cervix. J Clin Oncol. 2011 May 1;29(13):1678-85. doi: 10.1200/JCO.2009.25.9663. Epub 2011 Mar 28.
PubMed 21444871Ryu SY, Lee WM, Kim K, Park SI, Kim BJ, Kim MH, Choi SC, Cho CK, Nam BH, Lee ED. Randomized clinical trial of weekly vs. triweekly cisplatin-based chemotherapy concurrent with radiotherapy in the treatment of locally advanced cervical cancer. Int J Radiat Oncol Biol Phys. 2011 Nov 15;81(4):e577-81. doi: 10.1016/j.ijrobp.2011.05.002. Epub 2011 Aug 11.
PubMed 21840137Tang J, Tang Y, Yang J, Huang S. Chemoradiation and adjuvant chemotherapy in advanced cervical adenocarcinoma. Gynecol Oncol. 2012 May;125(2):297-302. doi: 10.1016/j.ygyno.2012.01.033. Epub 2012 Jan 31.
PubMed 22307061
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Study on Efficacy and Safety of Concurrent and Adjuvant Chemotherapy With Cisplatin and Docetaxel Combined With Radiotherapy for Local Advanced Cervical Cancer
- ClinicalTrials.gov ID
- NCT02703961
- Acronym / sponsor ID
- XJFL-2016-02-LACC-TP triweekly
- Conditions
- Cervical Cancer
- Keywords
- CCRT, adjuvant chemotherapy, cisplatin and docetaxel
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 598 participants (estimated)
- Lead sponsor
- Air Force Military Medical University, ChinaUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Feb 2018 (estimated)
- Study completion
- Feb 2021 (estimated)
- First posted
- 9 Mar 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 standard treatment of local advanced cervical cancer is concurrent chemoradiotherapy. The 3 year disease free survival was about 50-70%. The distant metastasis is the main cause of failure in local advanced cervical cancer treated with 3-dimensional conformal radiotherapy (3D-CRT) or intensity modulated radiotherapy (IMRT). The purpose of this study is to investigate the efficacy and tolerance of concurrent and adjuvant chemotherapy with cisplatin and docetaxel for local advanced cervical cancer. It was expected that the 3 year disease free survival would be increased by 10% with this new treatment schedule.
Detailed description
The cervical cancer is the most common malignant gynecological tumor in the developing area. From 1999, the concurrent chemoradiotherapy has been established as the standard treatment for local advanced cervical cancer. The modern radiotherapy techniques, such as 3 dimensional conformal radiotherapy(3D-CRT), intensity modulated radiotherapy(IMRT), image guided 3-dimensional brachytherapy(3D-BT), was widely used for the treatment of cervical cancer. The recently clinical outcome showed that the 3 year local and regional control was more than 90%［1-3］. The distant metastasis has proved to be the main cause of failure and death, especially for the patient with pelvic lymph node metastasis, large volume of tumor and advanced FIGO stage. the data showed that the 3 year distant metastasis free survival and overall survival were 64.7% and 64.6% respectively for the patient with huge pelvic lymph node metastasis and FIGO stage III- IVA. The system treatment pointing at the distant metastasis has become to be the topic of clinical investigation.
Dueñas-González A'［4］ study demonstrated that the 3 year progress free survival and distant metastasis free survival has increased by 8.9% and 8.3% by the radial radiotherapy combined with concurrent chemotherapy with weekly gemcitabine and cisplatin and adjuvant chemotherapy with triweekly gemcitabine and cisplatin. Ryu SY［5］ also reported the triweekly concurrent cisplatin with 3 cycles improved survival outcomes compared with weekly concurrent cisplatin. Retrospective studies by Tang and Jelavić-TB［6-7］ suggested that the adjubant chemotherapy after CCRT has better DMFS and OS.
The aim of present study is to prospectively investigate the efficacy and safety of concurrent and adjuvant chemotherapy with cisplatin and docetaxel for patients with local advanced cervical cancer, especially for those with FIGO III-IVA with or without pelvic lymph node metastasis and the FIGO IB2-IIB with pelvic lymph node metastasis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental | Experimental | Drug: concurrent chemotherapy with cisplatin, Drug: concurrent chemotherapy with docetaxel, Radiation: pelvic radiotherapy, Radiation: brachytherapy, Drug: adjuvant chemotherapy with cisplatin and docetaxelconcurrent and adjuvant chemotherapy with cisplatin and docetaxel combined radical radiotherapy. During external beam radiotherapy: cisplatin 60mg/m2, d1,d22; docetaxel 60mg/m2, d1,d22. After external beam radiotherapy: cisplatin 75mg/m2, d43,d64; The patients also undergo external-beam radiation therapy once daily, 5 days a week, for approximately 5 weeks. Patients then undergo high-dose rate intracavitary brachytherapy. docetaxel 75mg/m2, d43,d64. |
| control | Other | Drug: concurrent chemotherapy with cisplatin, Radiation: pelvic radiotherapy, Radiation: brachytherapystandard chemoradiotherapy with weekly cisplatin. Patients receive cisplatin IV over 60-90 minutes on days 1, 8, 15, 22, and 29. Patients also undergo external-beam radiation therapy once daily, 5 days a week, for approximately 5 weeks. Patients then undergo high-dose rate intracavitary brachytherapy. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Biopsy-proven, invasive squamous cell carcinoma, adenocarcinoma, or adenosquamouscarcinoma of the cervix
- FIGO clinical stage IB2-IIB with pelvic lymph node metastasis or FIGO clinical stage III-IVA with or without pelvic lymph node metastasis
- ECOG performance score 0-1
- The bone marrow, hepatic and renal function was normal at registration
- The patients signed informed consent
Key exclusion criteria (8 listed)
- clear cell and small cell neuroendocrine, sarcoma
- FIGO stage IVB
- Prior invasive malignancy
- Prior systemic chemotherapy
- Prior radiotherapy to the pelvis or abdomen
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 |
|---|---|---|
| concurrent chemotherapy with cisplatinAlso: cisplatinin experimental group: cisplatin 60mg/m2, d1,d22; | Drug | control, experimental |
| concurrent chemotherapy with docetaxelAlso: docetaxelin experimental group: docetaxel 60mg/m2, d1,d22; | Drug | experimental |
| pelvic radiotherapyAlso: external beam radiotherapyexternal beam radiotherapy for whole pelvix with 50Gy/25f boost radiotherapy for pelvic lymph node metastasis with 12-14Gy/4-7f. | Radiation | control, experimental |
| brachytherapyCT/MRI guided brachytherapy or x-ray guided brachytherapy | Radiation | control, experimental |
| adjuvant chemotherapy with cisplatin and docetaxelcisplatin 75mg/m2, d43,d64; docetaxel 75mg/m2, d43,d64 | Drug | experimental |
Primary outcome
disease free survival
Time frame: 3 year
1 secondary outcome
overall survival
Time frame: 3 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2016.
- Background: PubMed 26124372Jelavic TB, Mise BP, Strikic A, Ban M, Vrdoljak E. Adjuvant Chemotherapy in Locally Advanced Cervical Cancer After Treatment with Concomitant Chemoradiotherapy--Room for Improvement? Anticancer Res. 2015 Jul;35(7):4161-5.
- Results publication: PubMed 23603369Tharavichitkul E, Chakrabandhu S, Wanwilairat S, Tippanya D, Nobnop W, Pukanhaphan N, Galalae RM, Chitapanarux I. Intermediate-term results of image-guided brachytherapy and high-technology external beam radiotherapy in cervical cancer: Chiang Mai University experience. Gynecol Oncol. 2013 Jul;130(1):81-5. doi: 10.1016/j.ygyno.2013.04.018. Epub 2013 Apr 17.
- Results publication: PubMed 25680598Gill BS, Kim H, Houser CJ, Kelley JL, Sukumvanich P, Edwards RP, Comerci JT, Olawaiye AB, Huang M, Courtney-Brooks M, Beriwal S. MRI-guided high-dose-rate intracavitary brachytherapy for treatment of cervical cancer: the University of Pittsburgh experience. Int J Radiat Oncol Biol Phys. 2015 Mar 1;91(3):540-7. doi: 10.1016/j.ijrobp.2014.10.053. Epub 2015 Jan 30.
- Results publication: PubMed 26194683Tinkle CL, Weinberg V, Chen LM, Littell R, Cunha JAM, Sethi RA, Chan JK, Hsu IC. Inverse Planned High-Dose-Rate Brachytherapy for Locoregionally Advanced Cervical Cancer: 4-Year Outcomes. Int J Radiat Oncol Biol Phys. 2015 Aug 1;92(5):1093-1100. doi: 10.1016/j.ijrobp.2015.04.018. Epub 2015 Jul 14.
- Results publication: PubMed 21444871Duenas-Gonzalez A, Zarba JJ, Patel F, Alcedo JC, Beslija S, Casanova L, Pattaranutaporn P, Hameed S, Blair JM, Barraclough H, Orlando M. Phase III, open-label, randomized study comparing concurrent gemcitabine plus cisplatin and radiation followed by adjuvant gemcitabine and cisplatin versus concurrent cisplatin and radiation in patients with stage IIB to IVA carcinoma of the cervix. J Clin Oncol. 2011 May 1;29(13):1678-85. doi: 10.1200/JCO.2009.25.9663. Epub 2011 Mar 28.
- Results publication: PubMed 21840137Ryu SY, Lee WM, Kim K, Park SI, Kim BJ, Kim MH, Choi SC, Cho CK, Nam BH, Lee ED. Randomized clinical trial of weekly vs. triweekly cisplatin-based chemotherapy concurrent with radiotherapy in the treatment of locally advanced cervical cancer. Int J Radiat Oncol Biol Phys. 2011 Nov 15;81(4):e577-81. doi: 10.1016/j.ijrobp.2011.05.002. Epub 2011 Aug 11.
- Results publication: PubMed 22307061Tang J, Tang Y, Yang J, Huang S. Chemoradiation and adjuvant chemotherapy in advanced cervical adenocarcinoma. Gynecol Oncol. 2012 May;125(2):297-302. doi: 10.1016/j.ygyno.2012.01.033. Epub 2012 Jan 31.
- Individual participant dataSharing planned: Yes
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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, professor principal investigator
Xijing Hospital, the Fourth Military Medical University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing concurrent chemotherapy with cisplatin, concurrent chemotherapy with docetaxel and pelvic radiotherapy in people with Cervical Cancer, run by Air Force Military Medical University, China at 3 sites 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 5 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 17 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 mei shi, professor (0086-029-84775432, mshi82@fmmu.edu.cn), 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 year). 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 NCT02703961, which also lists 7 linked publications.
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 17 Mar 2016.