AzTrials
AzTrials

Endometrial CarcinomaPhase 1/2VICTORIANCT02730923

Hormone Receptor Positive endometrIal Carcinoma Treated by Dual mTORC1/mTORC2 Inhibitor and Anastrozole (VICTORIA)

A Phase 1/2 study testing AZD2014 and Anastrozole in people with Endometrial Carcinoma and Metastatic Carcinoma, run by Centre Leon Berard at 12 sites in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

The investigators hypothesize that the dual inhibition of mTORC1/mTORC2 by AZD2014 combined with inhibition of aromatase enzyme by anastrozole will act synergistically and may be an interesting therapeutic option for endometrial cancer with a manageable toxicity profile. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
AZD2014 and Anastrozole
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
72 participants
Where
12 sitesFrance
Study dates
Apr 2016to Dec 2024
Phase
Phase 1/2
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 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Postmenopausal female patient at the time of consent
  • Histologically-confirmed diagnosis of advanced or recurrent endometrial carcinoma, not amenable to curative treatments. Carcinosarcoma are not eligible.
  • Documented estrogen receptor and/or progesterone receptor positive endometrial cancer. Hormone receptor positivity is defined according to routine practice at each participating site.
  • Availability of a pre-treatment tumor sample (archival formalin-fixed paraffin-embedded (FFPE) block or fresh biopsy if feasible) and presence of at least one biopsiable tumor lesion for on-treatment biopsy
  • Documented disease progression after no more than one prior first-line chemotherapy regimen and/or more than 2 lines endocrine therapy in the metastatic setting
  • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1 and minimum life expectancy of 8 weeks
Show all 27Show fewer
  • At least one measurable lesion according to response evaluation criteria in solid tumor (RECIST 1.1)
  • Adequate bone marrow, renal and liver function as shown by:
  • Absolute neutrophil count > 1.5 x 109/L, Platelets > 100 x 109/L, Hemoglobin (Hb) >9 g/dL
  • Serum bilirubin ≤ 1.5 upper limit of normal (ULN), alanine aminotransferase and aspartate aminotransferase ≤ 2.5 ULN (≤ 5 ULN in patients with liver metastases)
  • Creatinine clearance > 50 mL/min (using Cockcroft formula, or MDRD formula for patients over 65 years Appendix 3 - Creatinine Clearance)
  • Fasting serum cholesterol ≤ 300 mg/dL (7.75 mmol/L) AND fasting triglycerides ≤ 2.5 ULN (lipid-lowering drugs allowed),
  • Fasting plasma glucose ≤7 mmol/L (126 mg/dL)
  • Recovered from prior significant treatment-related toxicity i.e. no persistent treatment-related toxicity > Grade 1 as per Common Terminology Criteria for Adverse Events (CTCAE) v4.3, except grade 2 alopecia, grade 2 anemia but with Hb >9 g/dL.
  • Minimal wash-out period before the start of the study drugs for the following treatments:
  • Any anti-cancer treatment approved or investigational medicinal product :> 21 days
  • Any chemotherapy, radiation therapy, androgens : > 21 days (not including palliative radiotherapy at focal sites).
  • Any monoclonal antibody therapy: > 4 weeks
  • Major surgery: > 4 weeks
  • Minor surgery (excluding tumour biopsies) >14 days.
  • Any haemopoietic growth factors (e.g., filgrastim [granulocyte colony-stimulating factor (G-CSF)], sargramostim [granulocyte-macrophage colony-stimulating factor (GM-CSF)]): > 14 days
  • Vaccinated with live, attenuated vaccines : > 4 weeks.
  • Sensitive or narrow therapeutic range substrates of drug transporters OATP1B1, OATP1B3, MATE1 and MATE2K: see the appropriate wash-out period (a minimum of 5 x reported elimination half-life) in Appendix 5 - Restricted CYP and transporter related co-medications
  • Potent or moderate inhibitors or inducers of CYP3A4/5, Pgp (MDR1) and BCRP - Restricted CYP and transporter related co-medications
  • Patient willing to follow sunlight-protection measures. Patients should be advised of the need for sunlight protection measures during administration of AZD2014, and should be advised to adopt such measures for a period of 3 months after receiving their final dose of AZD2014.
  • Patient able and willing to provide informed consent with ability to understand and willingness for follow-up visits.
  • Covered by a medical insurance

Who cannot join

  • Patient pre-treated by a non-steroidal aromatase inhibitor
  • Active uncontrolled or symptomatic central nervous system metastases or spinal cord compression
  • Clinically relevant abnormal levels of potassium or sodium.
  • Use of any forbidden concomitant treatment during the treatment period:
  • Any anti-cancer treatment (approved or investigational) not mentioned in the protocol
  • Chronic treatment with corticosteroids or other immunosuppressive agents. Stable low dose of corticosteroids are allowed (unless contra-indicated) provided that they were initiated before the last disease progression or were started at least 4 weeks prior to study treatment. Topical or inhaled corticosteroids are allowed.
Show all 23Show fewer
  • Potent or moderate inhibitors or inducers of CYP3A4/5, Pgp (MDR1) and BCRP (see Appendix 5 - Restricted CYP and transporter related co-medications)
  • Sensitive or narrow therapeutic range substrates of the drug transporters OATP1B1, OATP1B3, MATE1 and MATE2K outside the wash out period and restrictions presented in Appendix 5 - Restricted CYP and transporter related co-medications)
  • Patient with known hypersensitivity to anastrozole or to any of the excipients (Lactose monohydrate, Povidone, Sodium starch glycollate, Magnesium stearate, Hypromellose, Macrogol 300, Titanium dioxide)
  • History of hypersensitivity to active or inactive excipients of AZD2014 or drugs with a similar chemical structure or class to AZD2014
  • History of other malignancies except for basal cell or squamous cell skin cancer, in situ cervical cancer, unless they have been disease-free for at least five years
  • Patient who has any severe and/or uncontrolled medical conditions such as:
  • Recent history of specific cardiovascular events, or laboratory parameters that may affect cardiac parameters including : unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction ≤6 months prior to start of study drug, serious uncontrolled cardiac arrhythmia, or any other clinically significant cardiac disease; Symptomatic congestive heart failure of New York heart Association Class III or IV
  • Haemorrhagic or thrombotic stroke, including transient ischemic attack (TIA) or any other CNS bleeding.
  • Mean resting corrected QT interval (QTc), calculated using Fridericia's formula, > 470 msec obtained from 3 electrocardiograms (ECGs), family or personal history of long or short QT syndrome, Brugada syndrome or known history of QTc prolongation or Torsade de Pointes within 12 months of the patient entering in the study
  • Abnormal cardiac function at baseline :left ventricular ejection fraction (LVEF) <50%
  • Any evidence of interstitial lung disease and uncompensated respiratory conditions.
  • Active (acute or chronic) or uncontrolled severe infection, liver disease such as cirrhosis, decompensated liver disease, and active or chronic hepatitis (i.e. quantifiable hepatitis B virus (HBV-DNA) and/or positive HbsAg, quantifiable hepatitis C virus (HCV-RNA)),
  • Active, bleeding diathesis
  • Current refractory nausea and vomiting, chronic gastro-intestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption of AZD2014.
  • Rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption
  • Type 1 and uncontrolled Type 2 diabetes
  • Pre-existing renal disease including glomerulonephritis, nephritic syndrome, Fanconi Syndrome or renal tubular acidosis.

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

France12 sites

  • ICO - Paul Papin

    Angers

  • Institut Sainte Catherine

    Avignon, 84918

  • Hôpital Jean Minjoz

    Besançon, 25030

  • Institut Bergonié

    Bordeaux, 33076

  • Centre Francois Baclesse

    Caen

  • GHM Institut Daniel Hollard

    Grenoble, 38028

  • Centre Oscar Lambret

    Lille

  • Centre Léon Bérard

    Lyon

  • Institut régional du Cancer Montpellier (ICM)

    Montpellier, 34298

  • Hcl - Chls

    Pierre-Bénite

  • ICO - René Gauducheau

    Saint-Herblain

  • Institut Gustave Roussy

    Villejuif, 94805

Other trials in France

About this study

Official title: A Multicentric, Randomized, Non Comparative, Open-label Phase I/II Evaluating AZD2014 (Dual Mammalian Target of Rapamycin Complex 1/2 (mTORC1/mTORC2) Inhibitor) in Combination With Anastrozole Versus Anastrozole Alone in the Treatment of Metastatic Hormone Receptor-positive Endometrial Adenocarcinoma

The investigators hypothesize that the dual inhibition of mTORC1/mTORC2 by AZD2014 combined with inhibition of aromatase enzyme by anastrozole will act synergistically and may be an interesting therapeutic option for endometrial cancer with a manageable toxicity profile.

The investigators proposal is to conduct a multicenter, 2-step, randomized, Phase I/II trial to evaluate the safety and efficacy of a combination treatment associating anastrozole to AZD2014 in advanced endometrial cancer patients.

Read more

The study is divided in 2 steps :

  • A safety run-in phase aiming to evaluate the safety of the proposed combination AZD2014 + anastrozole (Arm A) versus anastrozole alone (Arm B). No dose escalation is scheduled (doses are based on maximum tolerated dose (MTD) defined for AZD2014 and the summary of product characteristics (SPC) of anastrozole). However, dose de-escalation for AZD2014 will be applied in case of toxicity.
  • A two-stage randomized Phase II part aiming to evaluate the clinical benefit of the AZD2014 + anastrozole (Arm A) combination therapy versus anastrozole (Arm B).
Read the detailed description

TREATMENT PLAN :

Following randomisation patients will receive Arm A : AZD2014 plus anastrozole or Arm B: anastrozole alone AZD2014 will be administered with an intermittent schedule i.e. 125 mg bis in die (BID) intermittent with 2 days on followed by 5 days off per week for a total weekly dose of 500 mg/week (250mg D1 and D2, 5 days off) Anastrozole will be administered at the standard dose defined in the SPC i.e. 1mg/d, per os, continuously.

Both treatment will be administered until progressive disease (PD), unacceptable toxicity or willingness to stop.

STATISTICS :

A total of 72 patients will be randomized in the study.

Safety run-in Phase on the first 9 patients randomized - As no dose escalation will be performed, the safety will be evaluated following the treatment and 8-week follow-up of the first 6 patients by the experimental association AZD2014+anastrozole (experimental arm). By similarity to a classic 3+3 design, based on binomial probabilities, there is a 90% probability of observing one or more patients with a toxicity event, if that event occurs in at least 32% of the target population. Assuming a 2:1 randomization ratio, a total of 9 patients (Arm A - Experimental: 6 patients, Arm B - Control: 3 patients) will be enrolled in this safety run-in phase and will be included in the evaluation of Phase II part.

Phase II The sample size calculation was based on a Simon optimal two-stage design, with a minimum success (8-week non progression) rate considered of interest p1=60% and an uninteresting rate p0=40%. Assuming a type I error alpha of 0.05 and 80% power, 46 evaluable patients are needed in the experimental arm to reject the null hypothesis H0: p≤p0 versus the alternative hypothesis H1: p ≥ p1 in a unilateral situation (16 patients in Stage I and 30 additional patients in Stage II).

With a 2:1 randomization and based on the assumption that 5% of the patients may be non-evaluable, a total of 72 patients will be included in the study : 48 patients in Arm A - experimental and 24 patients in Arm B - control).

DATA ENTRY, DATA MANAGEMENT AND STUDY MONITORING All the data concerning the patients will be recorded in the electronic case report form (eCRF) throughout the study. serious adverse event (SAE) reporting will be also paper-based by e-mail and/or Fax.

The sponsor will perform the study monitoring and will help the investigators to conduct the study in compliance with the clinical trial protocol, Good Clinical Practices (GCP) and local law requirements.

Being tested
AZD2014, Anastrozole
Keywords
Clinical Trials, Randomized, Clinical Trial, Phase I, Clinical Trial, Phase II, Multicenter Trials, Aromatase Inhibitors, mTOR kinase inhibitor
Medical subject headings
Endometrial Neoplasms, Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AZD2014Drug

    Following inclusion, patients will be randomized (2:1) to receive Arm A : AZD2014 + anastrozole Arm B : anastrozole alone

    Mode of Action Selective and specific mTOR kinase inhibitor targeting both mTORC1 and mTORC2 complexes.

    Route of Administration Oral

    Dosage regimen 125mg BID with intermittent schedule (2 days of treatment followed by 5 days off (500mg/week))

    Duration of treatment Until the patient experiences unacceptable toxicity, disease progression and/or treatment is discontinued per patient or investigator request.

  • AnastrozoleDrug

    Also called Arimidex

    Therapeutic Class Aromatase inhibitor

    Mode of Action Potent and highly selective non-steroidal aromatase inhibitor.

    Route of Administration Oral

    Dosage regimen

    1 mg tablet once a day

    Duration of treatment Patients may continue treatment with anastrozole until the patient experiences unacceptable toxicity, disease progression and/or treatment is discontinued per patient or investigator request.

Study groups in NCT02730923
Study groupRoleWhat they receive
Arm A: AZD2014 plus anastrozoleExperimentalNot described
Receives: Drug: AZD2014; Drug: Anastrozole
Arm B: anastrozole aloneActive comparatorNot described
Receives: Drug: Anastrozole

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of patients with severe toxicities occurring during the first 8 weeks of follow-up assessed using National Cancer Institute (NCI) common terminology criteria for adverse events (CTCAE) V4

    Severe toxicities defined as

    • Any grade ≥ 4 treatment related toxicity
    • Any grade≥ 3 treatment related toxicity lasting more than 7 days

    Measured: during the first 8 weeks of follow up

  2. The 8-week non progression rate using RECIST v1.1 to assess tumor response to treatment

    Measured: 8 weeks after start of treatment

Secondary outcomes (15)

  1. Number of patients with AE graded using CTCAE V4

    Measured: For each participant, up to 30 days after the last dose of treatment (up to 3 years)

  2. Progression-free survival (PFS) defined as the duration of time from start of treatment to time of progression or death, whichever occurs first

    Measured: up to 3 years

  3. Overall survival (OS) defined as the duration of time from start of treatment to time of death.

    Measured: 3 years

  4. Best response rate defined as (percentage of patients with complete response (CR), partial response (PR), stable disease (SD) or progressive disease (PD) according to RECIST V1.1)

    Measured: Up to 3 years

  5. Duration of objective response as per RECIST v1.1

    Measured: Up to 3 years

  6. Area under the curve (AUC) of AZD2014

    Measured: Week 1 Day 1: pre-dose, 2h and 6-8 hours later and Week 2 Day 1: pre-dose, 2h and 6-8 hours later.

  7. Apparent clearance of AZD2014

    Measured: Week 1 Day 1: pre-dose, 2h and 6-8 hours later and Week 2 Day 1: pre-dose, 2h and 6-8 hours later

  8. The accumulation of the 47S precursor ribosomal ribonucleic acid (rRNA), which reflects RNA polymerase I activity analysed by fluorescence in situ hybridization (FISH)

    Measured: Baseline and 8 weeks after treatment

  9. The expression of components of rRNA methylation complex analysed by real time quantitative PCR (RTqPCR)

    Measured: Baseline and 8 weeks after treatment

  10. The levels of circulating anti-fibrillarin (anti-FBL) autoantibody on serum samples by Elisa assays

    Measured: Baseline and 8 weeks after treatment

  11. Levels of expression of fibrillarin assessed by immunohistochemistry (IHC)

    Measured: Baseline and 8 weeks after treatment

  12. Levels of expression of nucleolin assessed by IHC

    Measured: Baseline and 8 weeks after treatment

  13. Levels of expression of protein B23 assessed by IHC

    Measured: Baseline and 8 weeks after treatment

  14. Levels of expression of upstream binding factor (UBF) assessed by IHC

    Measured: Baseline and 8 weeks after treatment

  15. Levels of expression of phosphorylated UBF assessed by IHC

    Measured: Baseline and 8 weeks after treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Apr 2016 (estimated)
  2. Study startApr 2016
  3. Primary completionNov 2019
  4. Study completionDec 2024 (estimated)

Resources

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 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
72 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02730923
Sponsor's protocol ID
VICTORIA (ET150036)
Acronym
VICTORIA
Status last verified
Sep 2023
First submitted
18 Mar 2016
Last updated
13 Feb 2024
Results posted
No
Data monitoring committee
Yes

Publications

  • Bokhman JV. Two pathogenetic types of endometrial carcinoma. Gynecol Oncol. 1983 Feb;15(1):10-7. doi: 10.1016/0090-8258(83)90111-7.

    PubMed 6822361

  • Levine DA, Hoskins WJ. Update in the management of endometrial cancer. Cancer J. 2002 May-Jun;8 Suppl 1:S31-40.

    PubMed 12075700

  • Murali R, Soslow RA, Weigelt B. Classification of endometrial carcinoma: more than two types. Lancet Oncol. 2014 Jun;15(7):e268-78. doi: 10.1016/S1470-2045(13)70591-6.

    PubMed 24872110

  • Creasman WT, Odicino F, Maisonneuve P, Quinn MA, Beller U, Benedet JL, Heintz AP, Ngan HY, Pecorelli S. Carcinoma of the corpus uteri. FIGO 26th Annual Report on the Results of Treatment in Gynecological Cancer. Int J Gynaecol Obstet. 2006 Nov;95 Suppl 1:S105-43. doi: 10.1016/S0020-7292(06)60031-3. No abstract available.

    PubMed 17161155

  • Sonoda Y. Optimal therapy and management of endometrial cancer. Expert Rev Anticancer Ther. 2003 Feb;3(1):37-47. doi: 10.1586/14737140.3.1.37.

    PubMed 12597348

  • Decruze SB, Green JA. Hormone therapy in advanced and recurrent endometrial cancer: a systematic review. Int J Gynecol Cancer. 2007 Sep-Oct;17(5):964-78. doi: 10.1111/j.1525-1438.2007.00897.x. Epub 2007 Apr 18.

    PubMed 17442022

  • Kokka F, Brockbank E, Oram D, Gallagher C, Bryant A. Hormonal therapy in advanced or recurrent endometrial cancer. Cochrane Database Syst Rev. 2010 Dec 8;2010(12):CD007926. doi: 10.1002/14651858.CD007926.pub2.

    PubMed 21154390

  • Rose PG, Brunetto VL, VanLe L, Bell J, Walker JL, Lee RB. A phase II trial of anastrozole in advanced recurrent or persistent endometrial carcinoma: a Gynecologic Oncology Group study. Gynecol Oncol. 2000 Aug;78(2):212-6. doi: 10.1006/gyno.2000.5865.

    PubMed 10926805

  • Diaz-Padilla I, Duran I, Clarke BA, Oza AM. Biologic rationale and clinical activity of mTOR inhibitors in gynecological cancer. Cancer Treat Rev. 2012 Oct;38(6):767-75. doi: 10.1016/j.ctrv.2012.02.001. Epub 2012 Feb 29.

    PubMed 22381585

  • Slomovitz BM, Coleman RL. The PI3K/AKT/mTOR pathway as a therapeutic target in endometrial cancer. Clin Cancer Res. 2012 Nov 1;18(21):5856-64. doi: 10.1158/1078-0432.CCR-12-0662. Epub 2012 Oct 18.

    PubMed 23082003

  • Oza AM, Elit L, Tsao MS, Kamel-Reid S, Biagi J, Provencher DM, Gotlieb WH, Hoskins PJ, Ghatage P, Tonkin KS, Mackay HJ, Mazurka J, Sederias J, Ivy P, Dancey JE, Eisenhauer EA. Phase II study of temsirolimus in women with recurrent or metastatic endometrial cancer: a trial of the NCIC Clinical Trials Group. J Clin Oncol. 2011 Aug 20;29(24):3278-85. doi: 10.1200/JCO.2010.34.1578. Epub 2011 Jul 25.

    PubMed 21788564

  • Slomovitz BM, Jiang Y, Yates MS, Soliman PT, Johnston T, Nowakowski M, Levenback C, Zhang Q, Ring K, Munsell MF, Gershenson DM, Lu KH, Coleman RL. Phase II study of everolimus and letrozole in patients with recurrent endometrial carcinoma. J Clin Oncol. 2015 Mar 10;33(8):930-6. doi: 10.1200/JCO.2014.58.3401. Epub 2015 Jan 26.

    PubMed 25624430

  • Jemal A, Siegel R, Ward E, Hao Y, Xu J, Thun MJ. Cancer statistics, 2009. CA Cancer J Clin. 2009 Jul-Aug;59(4):225-49. doi: 10.3322/caac.20006. Epub 2009 May 27.

    PubMed 19474385

  • Trimble EL, Harlan LC, Clegg LX, Stevens JL. Pre-operative imaging, surgery and adjuvant therapy for women diagnosed with cancer of the corpus uteri in community practice in the United States. Gynecol Oncol. 2005 Mar;96(3):741-8. doi: 10.1016/j.ygyno.2004.11.041.

    PubMed 15721420

  • Setiawan VW, Yang HP, Pike MC, McCann SE, Yu H, Xiang YB, Wolk A, Wentzensen N, Weiss NS, Webb PM, van den Brandt PA, van de Vijver K, Thompson PJ; Australian National Endometrial Cancer Study Group; Strom BL, Spurdle AB, Soslow RA, Shu XO, Schairer C, Sacerdote C, Rohan TE, Robien K, Risch HA, Ricceri F, Rebbeck TR, Rastogi R, Prescott J, Polidoro S, Park Y, Olson SH, Moysich KB, Miller AB, McCullough ML, Matsuno RK, Magliocco AM, Lurie G, Lu L, Lissowska J, Liang X, Lacey JV Jr, Kolonel LN, Henderson BE, Hankinson SE, Hakansson N, Goodman MT, Gaudet MM, Garcia-Closas M, Friedenreich CM, Freudenheim JL, Doherty J, De Vivo I, Courneya KS, Cook LS, Chen C, Cerhan JR, Cai H, Brinton LA, Bernstein L, Anderson KE, Anton-Culver H, Schouten LJ, Horn-Ross PL. Type I and II endometrial cancers: have they different risk factors? J Clin Oncol. 2013 Jul 10;31(20):2607-18. doi: 10.1200/JCO.2012.48.2596. Epub 2013 Jun 3.

    PubMed 23733771

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing AZD2014 and Anastrozole in people with Endometrial Carcinoma and Metastatic Carcinoma, run by Centre Leon Berard at 12 sites in France.

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 27 inclusion and 23 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 13 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in France. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

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?

Number of patients with severe toxicities occurring during the first 8 weeks of follow-up assessed using National Cancer Institute (NCI) common terminology criteria for adverse events (CTCAE) V4 (time frame: during the first 8 weeks of follow up). 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?

On the ClinicalTrials.gov record for NCT02730923, which also lists 49 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 13 Feb 2024.

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