Rectal CancerRECTAL BOOSTNCT01951521
RECTAL BOOST Study
A study testing Boost in people with Rectal Cancer, run by UMC Utrecht at 1 site in Netherlands.
Trial summary
Randomized controlled trial in which the effect is investigated of a radiation boost in addition to standard chemoradiation in patients with locally advanced rectal cancer on complete response rate defined as pathological complete response, in those who undergo surgery, or 2-years local recurrence-free survival… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- Boost
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Sep 2014to 1 Dec 2020
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant in the PLCRC project (ClinicalTrials.gov: NCT02070146)
- Informed consent obtained for being offered experimental interventions within the PLCRC project
- Informed consent obtained for questionnaires on patient reported outcomes within the PLCRC project
- WHO: 0-2
- Indication for chemoradiation based on primary tumor, regional nodes, metastasis (TNM) stage
- Referred for chemoradiation
- No contra-indication for MRI
- Tumor distance from ano-rectal transition ≤10 cm
Who cannot join
- <18 years
- No indication for chemoradiation according to Dutch guidelines based on TNM staging.
- Inflammatory bowel disease
- Prior pelvic radiotherapy
- At least one contra-indication for Capecitabine administration (based on Dihydropyrimidine dehydrogenase (DPD)-deficiency, bloodcount, liver malfunction, renal failure (Creatinine clearance <30 ml/min), medical history such as recent cardiac events
- Recent pregnancy ≤ 1 year ago
- Inadequate understanding of the Dutch language in speech and/or writing
Trial locations and contacts
1 site in 1 country.
About this study
Official title: RandomizEd Controlled Trial for Pre-operAtive Dose-escaLation BOOST in Locally Advanced Rectal Cancer
Randomized controlled trial in which the effect is investigated of a radiation boost in addition to standard chemoradiation in patients with locally advanced rectal cancer on complete response rate defined as pathological complete response, in those who undergo surgery, or 2-years local recurrence-free survival (2y-LRFS), in those who opted for a wait and see approach. Secondary objectives are adverse events due to chemoradiation (acute, perioperative and late toxicity), tumor response assessed with MRI, the impact of the boost on local and distant recurrence and survival as well as patient-reported quality of life and workability. The need for this comprehensive study is emphasized by the sub-optimal (radiation-) methods, heterogeneity between and poor reporting in the few previous trials in this field.
Read the detailed description
Rationale: The current treatment for locally advanced rectal cancer consists of pre-operative chemoradiation treatment (CRT) (50 Gray (Gy) in 25 fractions) followed by surgical resection, according to T-/N-stage, circumferential resection margin (CRM) and tumor localization (see table 1). After this neo-adjuvant treatment approximately 15% of patients show pathological complete response (pCR), i.e.no residual tumor in the resected specimen on pathologic examination. Patients with pCR have a lower risk of local and distant recurrences and significantly longer disease-free and overall survival. Furthermore, in these patients surgery could possibly have been omitted. Selected patients with a clinical complete response (cCR), defined prior to surgery by rectoscopy, rectal examination and magnetic resonance imaging (MRI), may opt for an organ-preserving therapy, a so called wait and see approach.
Response to chemoradiation occurs in a dose dependent fashion. Therefore, recent trials aimed to improve prognosis by radiation dose-escalation that resulted in improved pCR rates. Toxicity rates associated with radiation doses above 60 Gy are manageable and differ between studies; from increased to comparable or even lower toxicity. Moreover, dose escalation may increase the proportion of patients eligible for organ-preserving therapy.
Objective: We study whether addition of a radiation boost to standard chemoradiation in patients with locally advanced rectal cancer increases the complete response rate defined as pathological complete response, in those who undergo surgery, or 2-years local recurrence-free survival (2y-LRFS), in those who opted for a wait and see approach. Secondary objectives are adverse events due to chemoradiation (acute, perioperative and late toxicity), tumor response assessed with MRI, the impact of the boost on local and distant recurrence and survival as well as patient-reported quality of life and workability. The need for this comprehensive study is emphasized by the sub-optimal (radiation-) methods, heterogeneity between and poor reporting in the few previous trials in this field.
Study design: Multicentre Randomized Controlled Trial, nested within a prospective cohort according to the 'cohort multiple randomized controlled trial' (cmRCT) design.
Study population: Rectal cancer patients participating in a prospective cohort (the PLCRC project) and diagnosed with adenocarcinoma of the rectum whom will undergo chemoradiation based on clinical criteria (see table 1 section 1.2.1).
Intervention: An irradiation boost of 15 Gy delivered to the gross tumor volume (GTV) in 5 fractions in addition to the standard chemoradiation treatment of 50 Gy. Thereby increasing the total GTV dose to 65 Gy.
Main study parameters/endpoints: The primary endpoint is complete response either defined as pathological complete response (pCR) in patients who undergo surgery, assessed by standardized pathologic examination of the surgical specimen, or 2-years local recurrence-free survival (LRFS) after chemoradiation in patients who opted for a wait and see approach. Secondary outcomes are treatment acute, perioperative and late toxicity, tumor response assessed with MRI, patient-reported quality of life and workability, local recurrence and (disease-specific) survival.
- Conditions
- Rectal Cancer
- Being tested
- Boost
- Keywords
- Rectal cancer, Locally advanced rectal cancer, Radiotherapy, Boost, Dose-escalation, Pathological complete response, Response
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BoostRadiation
External Beam radiation delivered using intensity modulation radiation therapy (IMRT) planning, consisting of 15 Gy (in 5 sequential fractions).
| Study group | Role | What they receive |
|---|---|---|
| Boost | Experimental | Boost radiation consists of 5 fractions of 3 Gy (total 15 Gy) delivered to the tumor (Gross Tumor Volume) additional to standard chemoradiation of 50 Gy with Capecitabine. Receives: Radiation: Boost |
| Standard chemoradiation | No intervention | Standard chemoradiation consisting of 25 x 2 Gy (total 50 Gy) with Capecitabine. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete response rate
The primary endpoint is complete response either defined as pathological complete response (pCR) in patients who undergo surgery, assessed by standardized pathologic examination of the surgical specimen, or 2-years local recurrence-free survival (LRFS) after chemoradiation in patients who opted for a wait and see approach.
Measured: pathologic examination following surgery, at aproximately 13-15 weeks (control arm) or 14-16 weeks (boost arm) after randomization or clinical complete respons of 2 years after first response assessment.
Secondary outcomes (6)
Acute toxicity in common toxicity criteria for adverse events (CTCAE).
Outcomes are assessed according to Common Toxicity Criteria for Adverse Events (CTCAE) (v4.0).
Measured: Until surgery at 8-10 weeks post chemoradiation (which is 13-15 weeks (control) or 14-16 weeks (boost) post randomization
Patient reported quality of life
at baseline and 3, 6, 12 and 24 months after treatment. Patient reported outcome (Quality of life (QoL)) is measured by validated questionnaires.
QoL: European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 and CR-29 (these acronyms indicate cancer and colorectal cancer specific questionnaires.
Measured: at baseline and 3, 6, 12 and 24 months after treatment.
Tumor response on Magnetic resonance imaging (MRI)
During (week 2) and after (7-8 weeks post) chemoradiation tumor response is assessed by (several) MRI (sequences such as T1, T2 and DWI).
Measured: at week 2 during chemoradiation and week 7 post chemoradiation.
Patient reported workability
validated questionnaires. Patient reported outcome (workability) is measured by Workability index.
Measured: at baseline and 3, 6, 12 and 24 months after treatment.
Surgical complication
Dutch Surgical Colorectal Audit criteria for surgical complication. This includes wound-infection, wound-healing (time), hospitalization (time), supportive treatment.
Measured: untill 30 days after surgery, which is 17-19 weeks (control) or 18-20 weeks (boost) post randomization
(disease-free) survival
Survival is measured, as well as other clinical data, in the PICNIC Cohort (ProspectIve data CollectioN Initiative on Colorectal cancer) reviewed by Dutch Medical Ethics Committee @ University Medical Center Utrecht, under number 12-510.
Measured: up to death of included patients, for a maximum of 60 years post-randomization.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2013 (estimated)
- Study start1 Sep 2014
- Primary completion1 Dec 2020 (estimated)
- Study completion1 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- More trials run by UMC UtrechtThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- cohort multiple randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Collaborators
- Maastro Clinic, The Netherlands
- Responsible party
- Principal investigator, Helena M Verkooijen, UMC Utrecht
- Investigators
- HM Verkooijen, MD PhD, Principal investigator, Imaging Division, UMC UtrechtM. Berbee, MD PhD, Principal investigator, Radiation-Oncology, MAASTRO clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01951521
- Sponsor's protocol ID
- NL46051.041.13
- Acronym
- RECTAL BOOST
- Status last verified
- Sep 2019
- First submitted
- 18 Sep 2013
- Last updated
- 25 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Verweij ME, Hoendervangers S, Couwenberg AM, Burbach JPM, Berbee M, Buijsen J, Roodhart J, Reerink O, Pronk A, Consten ECJ, Smits AB, Heikens JT, van Grevenstein WHMU, Intven MPW, Verkooijen HLM. Impact of Dose-Escalated Chemoradiation on Quality of Life in Patients With Locally Advanced Rectal Cancer: 2-Year Follow-Up of the Randomized RECTAL-BOOST Trial. Int J Radiat Oncol Biol Phys. 2022 Mar 1;112(3):694-703. doi: 10.1016/j.ijrobp.2021.09.052. Epub 2021 Oct 8.
PubMed 34634436Couwenberg AM, Burbach JPM, Berbee M, Lacle MM, Arensman R, Raicu MG, Wessels FJ, Verdult J, Roodhart J, Reerink O, Hoendervangers S, Buijsen J, Grabsch HI, Pronk A, Consten ECJ, Smits AB, Heikens JT, Appelt AL, van Grevenstein WMU, Verkooijen HM, Intven MPW. Efficacy of Dose-Escalated Chemoradiation on Complete Tumor Response in Patients with Locally Advanced Rectal Cancer (RECTAL-BOOST): A Phase 2 Randomized Controlled Trial. Int J Radiat Oncol Biol Phys. 2020 Nov 15;108(4):1008-1018. doi: 10.1016/j.ijrobp.2020.06.013. Epub 2020 Jun 19.
PubMed 32565319Couwenberg AM, Burbach JPM, May AM, Berbee M, Intven MPW, Verkooijen HM. The trials within cohorts design facilitated efficient patient enrollment and generalizability in oncology setting. J Clin Epidemiol. 2020 Apr;120:33-39. doi: 10.1016/j.jclinepi.2019.12.015. Epub 2019 Dec 19.
PubMed 31866471Burbach JP, Verkooijen HM, Intven M, Kleijnen JP, Bosman ME, Raaymakers BW, van Grevenstein WM, Koopman M, Seravalli E, van Asselen B, Reerink O. RandomizEd controlled trial for pre-operAtive dose-escaLation BOOST in locally advanced rectal cancer (RECTAL BOOST study): study protocol for a randomized controlled trial. Trials. 2015 Feb 22;16:58. doi: 10.1186/s13063-015-0586-4.
PubMed 25888548
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RandomizEd Controlled Trial for Pre-operAtive Dose-escaLation BOOST in Locally Advanced Rectal Cancer
- ClinicalTrials.gov ID
- NCT01951521
- Acronym / sponsor ID
- RECTAL BOOST / NL46051.041.13
- Conditions
- Rectal Cancer
- Keywords
- Rectal cancer, Locally advanced rectal cancer, Radiotherapy, Boost, Dose-escalation, Pathological complete response, Response
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 128 participants (actual)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Collaborators
- Maastro Clinic, The Netherlands
- Study start
- 1 Sep 2014 (actual)
- Primary completion
- 1 Dec 2020 (estimated)
- Study completion
- 1 Dec 2020 (estimated)
- First posted
- 26 Sep 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.
Randomized controlled trial in which the effect is investigated of a radiation boost in addition to standard chemoradiation in patients with locally advanced rectal cancer on complete response rate defined as pathological complete response, in those who undergo surgery, or 2-years local recurrence-free survival (2y-LRFS), in those who opted for a wait and see approach. Secondary objectives are adverse events due to chemoradiation (acute, perioperative and late toxicity), tumor response assessed with MRI, the impact of the boost on local and distant recurrence and survival as well as patient-reported quality of life and workability. The need for this comprehensive study is emphasized by the sub-optimal (radiation-) methods, heterogeneity between and poor reporting in the few previous trials in this field.
Detailed description
Rationale: The current treatment for locally advanced rectal cancer consists of pre-operative chemoradiation treatment (CRT) (50 Gray (Gy) in 25 fractions) followed by surgical resection, according to T-/N-stage, circumferential resection margin (CRM) and tumor localization (see table 1). After this neo-adjuvant treatment approximately 15% of patients show pathological complete response (pCR), i.e.no residual tumor in the resected specimen on pathologic examination. Patients with pCR have a lower risk of local and distant recurrences and significantly longer disease-free and overall survival. Furthermore, in these patients surgery could possibly have been omitted. Selected patients with a clinical complete response (cCR), defined prior to surgery by rectoscopy, rectal examination and magnetic resonance imaging (MRI), may opt for an organ-preserving therapy, a so called wait and see approach.
Response to chemoradiation occurs in a dose dependent fashion. Therefore, recent trials aimed to improve prognosis by radiation dose-escalation that resulted in improved pCR rates. Toxicity rates associated with radiation doses above 60 Gy are manageable and differ between studies; from increased to comparable or even lower toxicity. Moreover, dose escalation may increase the proportion of patients eligible for organ-preserving therapy.
Objective: We study whether addition of a radiation boost to standard chemoradiation in patients with locally advanced rectal cancer increases the complete response rate defined as pathological complete response, in those who undergo surgery, or 2-years local recurrence-free survival (2y-LRFS), in those who opted for a wait and see approach. Secondary objectives are adverse events due to chemoradiation (acute, perioperative and late toxicity), tumor response assessed with MRI, the impact of the boost on local and distant recurrence and survival as well as patient-reported quality of life and workability. The need for this comprehensive study is emphasized by the sub-optimal (radiation-) methods, heterogeneity between and poor reporting in the few previous trials in this field.
Study design: Multicentre Randomized Controlled Trial, nested within a prospective cohort according to the 'cohort multiple randomized controlled trial' (cmRCT) design.
Study population: Rectal cancer patients participating in a prospective cohort (the PLCRC project) and diagnosed with adenocarcinoma of the rectum whom will undergo chemoradiation based on clinical criteria (see table 1 section 1.2.1).
Intervention: An irradiation boost of 15 Gy delivered to the gross tumor volume (GTV) in 5 fractions in addition to the standard chemoradiation treatment of 50 Gy. Thereby increasing the total GTV dose to 65 Gy.
Main study parameters/endpoints: The primary endpoint is complete response either defined as pathological complete response (pCR) in patients who undergo surgery, assessed by standardized pathologic examination of the surgical specimen, or 2-years local recurrence-free survival (LRFS) after chemoradiation in patients who opted for a wait and see approach. Secondary outcomes are treatment acute, perioperative and late toxicity, tumor response assessed with MRI, patient-reported quality of life and workability, local recurrence and (disease-specific) survival.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- cohort multiple randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Boost | Experimental | Radiation: BoostBoost radiation consists of 5 fractions of 3 Gy (total 15 Gy) delivered to the tumor (Gross Tumor Volume) additional to standard chemoradiation of 50 Gy with Capecitabine. |
| Standard chemoradiation | No intervention | –Standard chemoradiation consisting of 25 x 2 Gy (total 50 Gy) with Capecitabine. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Participant in the PLCRC project (ClinicalTrials.gov: NCT02070146)
- Informed consent obtained for being offered experimental interventions within the PLCRC project
- Informed consent obtained for questionnaires on patient reported outcomes within the PLCRC project
- WHO: 0-2
- Indication for chemoradiation based on primary tumor, regional nodes, metastasis (TNM) stage
Key exclusion criteria (7 listed)
- <18 years
- No indication for chemoradiation according to Dutch guidelines based on TNM staging.
- Inflammatory bowel disease
- Prior pelvic radiotherapy
- At least one contra-indication for Capecitabine administration (based on Dihydropyrimidine dehydrogenase (DPD)-deficiency, bloodcount, liver malfunction, renal failure (Creatinine clearance <30 ml/min), medical history such as recent cardiac events
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 |
|---|---|---|
| BoostExternal Beam radiation delivered using intensity modulation radiation therapy (IMRT) planning, consisting of 15 Gy (in 5 sequential fractions). | Radiation | Boost |
Primary outcome
Complete response rate
Time frame: pathologic examination following surgery, at aproximately 13-15 weeks (control arm) or 14-16 weeks (boost arm) after randomization or clinical complete respons of 2 years after first response assessment.
The primary endpoint is complete response either defined as pathological complete response (pCR) in patients who undergo surgery, assessed by standardized pathologic examination of the surgical specimen, or 2-years local recurrence-free survival (LRFS) after chemoradiation in patients who opted for a wait and see approach.
6 secondary outcomes
Acute toxicity in common toxicity criteria for adverse events (CTCAE).
Time frame: Until surgery at 8-10 weeks post chemoradiation (which is 13-15 weeks (control) or 14-16 weeks (boost) post randomization
Patient reported quality of life
Time frame: at baseline and 3, 6, 12 and 24 months after treatment.
Tumor response on Magnetic resonance imaging (MRI)
Time frame: at week 2 during chemoradiation and week 7 post chemoradiation.
Patient reported workability
Time frame: at baseline and 3, 6, 12 and 24 months after treatment.
Surgical complication
Time frame: untill 30 days after surgery, which is 17-19 weeks (control) or 18-20 weeks (boost) post randomization
(disease-free) survival
Time frame: up to death of included patients, for a maximum of 60 years post-randomization.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2019.
- Derived from this study: PubMed 34634436Verweij ME, Hoendervangers S, Couwenberg AM, Burbach JPM, Berbee M, Buijsen J, Roodhart J, Reerink O, Pronk A, Consten ECJ, Smits AB, Heikens JT, van Grevenstein WHMU, Intven MPW, Verkooijen HLM. Impact of Dose-Escalated Chemoradiation on Quality of Life in Patients With Locally Advanced Rectal Cancer: 2-Year Follow-Up of the Randomized RECTAL-BOOST Trial. Int J Radiat Oncol Biol Phys. 2022 Mar 1;112(3):694-703. doi: 10.1016/j.ijrobp.2021.09.052. Epub 2021 Oct 8.
- Derived from this study: PubMed 32565319Couwenberg AM, Burbach JPM, Berbee M, Lacle MM, Arensman R, Raicu MG, Wessels FJ, Verdult J, Roodhart J, Reerink O, Hoendervangers S, Buijsen J, Grabsch HI, Pronk A, Consten ECJ, Smits AB, Heikens JT, Appelt AL, van Grevenstein WMU, Verkooijen HM, Intven MPW. Efficacy of Dose-Escalated Chemoradiation on Complete Tumor Response in Patients with Locally Advanced Rectal Cancer (RECTAL-BOOST): A Phase 2 Randomized Controlled Trial. Int J Radiat Oncol Biol Phys. 2020 Nov 15;108(4):1008-1018. doi: 10.1016/j.ijrobp.2020.06.013. Epub 2020 Jun 19.
- Derived from this study: PubMed 31866471Couwenberg AM, Burbach JPM, May AM, Berbee M, Intven MPW, Verkooijen HM. The trials within cohorts design facilitated efficient patient enrollment and generalizability in oncology setting. J Clin Epidemiol. 2020 Apr;120:33-39. doi: 10.1016/j.jclinepi.2019.12.015. Epub 2019 Dec 19.
- Derived from this study: PubMed 25888548Burbach JP, Verkooijen HM, Intven M, Kleijnen JP, Bosman ME, Raaymakers BW, van Grevenstein WM, Koopman M, Seravalli E, van Asselen B, Reerink O. RandomizEd controlled trial for pre-operAtive dose-escaLation BOOST in locally advanced rectal cancer (RECTAL BOOST study): study protocol for a randomized controlled trial. Trials. 2015 Feb 22;16:58. doi: 10.1186/s13063-015-0586-4.
- The PLCRC ProjectLink provided by the sponsor.
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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.
HM Verkooijen, MD PhD principal investigator
Imaging Division, UMC Utrecht
M. Berbee, MD PhD principal investigator
Radiation-Oncology, MAASTRO clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Boost in people with Rectal Cancer, run by UMC Utrecht at 1 site in Netherlands.
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 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 25 Sep 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 Netherlands. 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.
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?
Complete response rate (time frame: pathologic examination following surgery, at aproximately 13-15 weeks (control arm) or 14-16 weeks (boost arm) after randomization or clinical complete respons of 2 years after first response assessment.). 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 NCT01951521, which also lists 4 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 25 Sep 2019.