Stomach NeoplasmPhase 3PERISCOPEIINCT03348150
Gastrectomy + Cytoreductive Surgery + HIPEC for Gastric Cancer With Peritoneal Dissemination.
A Phase 3 study testing Cytoreductive surgery + Gastrecomy and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in people with Stomach Neoplasm and Peritoneal Carcinomatosis, run by The Netherlands Cancer Institute at 1 site in Netherlands.
Trial summary
A randomized controlled two-armed phase III trial for gastric cancer patients with peritoneal dissemination. Randomization between gastrectomy + cytoreductive surgery + HIPEC (experimental arm) and palliative systemic chemotherapy (standard arm). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stomach Neoplasm, Peritoneal Carcinomatosis
- What is being tested?
- Cytoreductive surgery + Gastrecomy and Hyperthermic Intraperitoneal Chemotherapy (HIPEC)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Oct 2017to 1 Oct 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
- Age ≥ 18 years
- Biopsy proven primary adenocarcinoma (or undifferentiated carcinoma) of the stomach. Including tumours at the oesophagogastric junction provided that the bulk of the tumour is located in the stomach, and, the intended surgical treatment is a gastric resection and not an oesophagectomy. A high intra-thoracic anastomosis is allowed, but not if a thoracotomy is necessary.
- cT3-cT4 tumour (TNM classification, 7th edition), considered to be resectable (including lymph nodes)
- Limited peritoneal carcinomatosis (PCI <7) and/ or tumour positive peritoneal cytology confirmed by laparoscopy or laparotomy and proven by pathological examination
- Treatment with systemic chemotherapy, with the latest course ending within 8 weeks prior to inclusion. All currently standard chemotherapy regimens are acceptable
- Absence of disease progression during systemic chemotherapy (prior to inclusion)
Show all 17Show fewer
- WHO performance status 0-2
- Adequate bone marrow, hepatic and renal function. Minimally acceptable laboratory values at start of the study inclusion:
- ANC ≥ 1.5 x 109 /L
- Platelet count ≥ 100 x 109 /L
- Serum bilirubin ≤ 1.5 x ULN, and ALAT and ASAT ≤ 2.5 x ULN
- Creatinine clearance ≥ 50 ml/min (measured or calculated by Cockcroft-Gault formula)
- For female patients who are not sterilised or in menopause (i.e., amenorrhea ≥1 year if age ≥60 years, or ≥2 years if age <60 years):
- negative pregnancy test (urine/serum)
- no breast feeding or active pregnancy ambition
- reliable contraceptive methods
- Signed informed consent
Who cannot join
- Distant metastases (e.g., liver, lung, para-aortic lymph nodes; i.e., stations 14 and 16) or small bowel dissemination
- Recurrent gastric cancer
- Prior resection of the primary gastric tumour
- Non-synchronous peritoneal carcinomatosis
- Current other malignancy (other than cervix carcinoma and basalioma)
- Uncontrolled infectious disease or known infection with Human Immunodeficiency Virus type -1 or -2
Show all 10Show fewer
- A known history of hepatitis B or C with active viral replication
- Recent myocardial infarction (< 6 months) or unstable angina
- Any medical condition not yet specified above that is considered to interfere with study procedures, including adequate follow-up and compliance and/or would jeopardise safe treatment
- Known hypersensitivity for any of the applied chemotherapeutic agents and/or their solvents
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Antoni van Leeuwenhoek/ Netherlands Cancer institute
Amsterdam, 1066CZ
About this study
Official title: Treatment of Peritoneal Dissemination in Stomach Cancer Patients With Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy (HIPEC).
A randomized controlled two-armed phase III trial for gastric cancer patients with peritoneal dissemination. Randomization between gastrectomy + cytoreductive surgery + HIPEC (experimental arm) and palliative systemic chemotherapy (standard arm).
Read the detailed description
Rationale: For gastric cancer patients with peritoneal carcinomatosis palliative systemic chemotherapy is the standard treatment in the Netherlands. There are no potentially curative treatment options. Peritoneal carcinomatosis, in contrast to lymphatic and haematogenous dissemination, should be regarded as locoregional extension of disease. Administering chemotherapeutic drugs directly into the peritoneal cavity has an advantage over systemic chemotherapy since high concentrations of cytotoxic drugs can be delivered directly into the peritoneal cavity with little systemic toxicity. The combination of intraperitoneally administered chemotherapy with cytoreductive surgery and a radical gastrectomy has shown promising results in gastric cancer patients in Asia. As with other gastric cancer issues, the results obtained in Asian patients cannot be extrapolated directly to Western patients.
Objective: The primary aim of this study is to compare the overall survival between gastric cancer patients with limited peritoneal carcinomatosis and/ or tumour positive peritoneal cytology treated with gastrectomy, cytoreductive surgery and HIPEC and those treated with the current standard treatment, i.e. palliative systemic chemotherapy.
Study design : This is a multicentre randomised controlled two-armed phase III trial. Patients will be randomised (1:1) between palliative systemic chemotherapy only (standard treatment) and gastrectomy combined with cytoreductive surgery and HIPEC (experimental treatment).
Study population: Gastric cancer patients are eligible for inclusion if (1) the primary cT3-cT4 gastric tumour including regional lymph nodes is considered to be resectable, (2) limited peritoneal carcinomatosis (<7) and/ or tumour positive cytology is confirmed by laparoscopy or laparotomy, and (3) systemic chemotherapy (prior to inclusion) was without disease progression.
Main study parameters/endpoints: The study sample size (182 patients) is calculated from the hypothesis that the median overall survival of the patients treated according to protocol in the experimental arm is 18 months, as compared to a median overall survival of 10 months in the standard arm. Statistical analysis will be done according to the intention-to-treat principle.
- Conditions
- Stomach Neoplasm, Peritoneal Carcinomatosis
- Being tested
- Cytoreductive surgery + Gastrecomy, Hyperthermic Intraperitoneal Chemotherapy (HIPEC)
- Keywords
- HIPEC, Hyperthermic Intraperitoneal Chemotherapy, gastrectomy, cytoreductive surgery, oxaliplatin, docetaxel
- Medical subject headings
- Stomach Neoplasms, Peritoneal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cytoreductive surgery + GastrecomyProcedure or surgery
Complete cytoreduction followed by a (sub)total gastric resection with D2 lymphadenectomy.
Hyperthermic Intraperitoneal Chemotherapy (HIPEC)Drug
Also called HIPEC
HIPEC: perfusion with oxaliplatin (460mg/m2 ) (42 °C) followed by docetaxel (50mg/m2 ) (37°C)
| Study group | Role | What they receive |
|---|---|---|
| Gastrecomy + Cytoreductive surgery + HIPEC | Experimental | Gastrectomy combined with cytoreductive surgery and HIPEC (experimental treatment) Receives: Procedure: Cytoreductive surgery + Gastrecomy; Drug: Hyperthermic Intraperitoneal Chemotherapy (HIPEC) |
| palliative systemic chemotherapy | No intervention | Palliative systemic chemotherapy only (standard treatment) |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival
To compare the overall survival between gastric cancer patients with limited peritoneal carcinomatosis and/ or tumour positive peritoneal cytology treated with gastrectomy, cytoreductive surgery and HIPEC and those treated with the current standard treatment, i.e. palliative systemic chemotherapy.
Measured: 5 years
Secondary outcomes (3)
progression free survival
To compare the progression free survival between gastric cancer patients with limited peritoneal carcinomatosis and/ or tumour positive peritoneal cytology treated with gastrectomy, cytoreductive surgery and HIPEC and those treated with the current standard treatment, i.e. palliative systemic chemotherapy.
Measured: 5 years
treatment-related toxicity
To study treatment-related toxicity in gastric cancer patients with limited peritoneal carcinomatosis and/ or tumour positive peritoneal cytology treated with gastrectomy, cytoreductive surgery and HIPEC.
Measured: 5 years
costs and health benefits
To compare the costs and health benefits of a gastrectomy in combination with cytoreductive surgery and HIPEC, to the costs and health benefits of standard palliative systemic chemotherapy in patients with limited peritoneal carcinomatosis and/ or tumour positive peritoneal cytology.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2017
- Study start1 Oct 2017
- Primary completion17 Sep 2025 (estimated)
- Study completion1 Oct 2027 (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 Stomach NeoplasmStudies of the same condition, open and under way.
- More trials run by The Netherlands Cancer InstituteThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1:1 randomization
- Masking
- None (open label)
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Netherlands Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Erasmus Medical Center, UMC Utrecht, University Medical Center Groningen, Catharina Ziekenhuis Eindhoven
- Responsible party
- Sponsor
- Investigators
- Johanna van Sandick, MD, PHD, Principal investigator, Surgeon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03348150
- Sponsor's protocol ID
- M15PEC
- Other IDs
- 2015-005695-15, NL56123.031.15, 2015
- Acronym
- PERISCOPEII
- Status last verified
- Jul 2025
- First submitted
- 15 Nov 2017
- Last updated
- 17 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
van der Kaaij RT, Braam HJ, Boot H, Los M, Cats A, Grootscholten C, Schellens JH, Aalbers AG, Huitema AD, Knibbe CA, Boerma D, Wiezer MJ, van Ramshorst B, van Sandick JW. Treatment of Peritoneal Dissemination in Stomach Cancer Patients With Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy (HIPEC): Rationale and Design of the PERISCOPE Study. JMIR Res Protoc. 2017 Jul 13;6(7):e136. doi: 10.2196/resprot.7790.
PubMed 28705789Quik JSE, Vollebergh MA, Retel VP, van der Sluis K, Koemans WJ, van der Kaaij RT, Voets MM, Luyer MDP, van Hellemond IEG, Wijnhoven BPL, Mostert B, van Hillegersberg R, Mohammad NH, van Etten B, de Groot DJ, Helminen O, Hedberg J, Cashin PH, Harbjerg JL, Veenhof AAFA, Hartemink KJ, Kodach LL, van der Noort V, van Sandick JW; PERISCOPE II consortium. Systemic therapy, gastrectomy, cytoreductive surgery, and hyperthermic intraperitoneal chemotherapy versus systemic therapy alone for gastric cancer with limited peritoneal metastases (PERISCOPE II): final results of a multicentre, randomised, controlled, phase 3 trial after an unplanned commissioned interim analysis. Lancet Oncol. 2026 Aug;27(8):1031-1042. doi: 10.1016/S1470-2045(26)00144-0. Epub 2026 Jul 8.
PubMed 42419336Rijken A, Pape M, Simkens GA, de Hingh IHJT, Luyer MDP, van Sandick JW, van Laarhoven HWM, Verhoeven RHA, van Erning FN. Peritoneal metastases from gastric cancer in a nationwide cohort: Incidence, treatment and survival. Int J Cancer. 2024 Mar 15;154(6):992-1002. doi: 10.1002/ijc.34780. Epub 2023 Nov 2.
PubMed 37916797Koemans WJ, van der Kaaij RT, Boot H, Buffart T, Veenhof AAFA, Hartemink KJ, Grootscholten C, Snaebjornsson P, Retel VP, van Tinteren H, Vanhoutvin S, van der Noort V, Houwink A, Hahn C, Huitema ADR, Lahaye M, Los M, van den Barselaar P, Imhof O, Aalbers A, van Dam GM, van Etten B, Wijnhoven BPL, Luyer MDP, Boerma D, van Sandick JW. Cytoreductive surgery and hyperthermic intraperitoneal chemotherapy versus palliative systemic chemotherapy in stomach cancer patients with peritoneal dissemination, the study protocol of a multicentre randomised controlled trial (PERISCOPE II). BMC Cancer. 2019 May 6;19(1):420. doi: 10.1186/s12885-019-5640-2.
PubMed 31060544
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Peritoneal Dissemination in Stomach Cancer Patients With Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy (HIPEC).
- ClinicalTrials.gov ID
- NCT03348150
- Acronym / sponsor ID
- PERISCOPEII / M15PEC
- Conditions
- Stomach Neoplasm, Peritoneal Carcinomatosis
- Keywords
- HIPEC, Hyperthermic Intraperitoneal Chemotherapy, gastrectomy, cytoreductive surgery, oxaliplatin, docetaxel
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- The Netherlands Cancer InstituteUniversity, hospital or other
- Collaborators
- Erasmus Medical Center, UMC Utrecht, University Medical Center Groningen, Catharina Ziekenhuis Eindhoven
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 17 Sep 2025 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 20 Nov 2017 (actual)
- 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.
A randomized controlled two-armed phase III trial for gastric cancer patients with peritoneal dissemination. Randomization between gastrectomy + cytoreductive surgery + HIPEC (experimental arm) and palliative systemic chemotherapy (standard arm).
Detailed description
Rationale: For gastric cancer patients with peritoneal carcinomatosis palliative systemic chemotherapy is the standard treatment in the Netherlands. There are no potentially curative treatment options. Peritoneal carcinomatosis, in contrast to lymphatic and haematogenous dissemination, should be regarded as locoregional extension of disease. Administering chemotherapeutic drugs directly into the peritoneal cavity has an advantage over systemic chemotherapy since high concentrations of cytotoxic drugs can be delivered directly into the peritoneal cavity with little systemic toxicity. The combination of intraperitoneally administered chemotherapy with cytoreductive surgery and a radical gastrectomy has shown promising results in gastric cancer patients in Asia. As with other gastric cancer issues, the results obtained in Asian patients cannot be extrapolated directly to Western patients.
Objective: The primary aim of this study is to compare the overall survival between gastric cancer patients with limited peritoneal carcinomatosis and/ or tumour positive peritoneal cytology treated with gastrectomy, cytoreductive surgery and HIPEC and those treated with the current standard treatment, i.e. palliative systemic chemotherapy.
Study design : This is a multicentre randomised controlled two-armed phase III trial. Patients will be randomised (1:1) between palliative systemic chemotherapy only (standard treatment) and gastrectomy combined with cytoreductive surgery and HIPEC (experimental treatment).
Study population: Gastric cancer patients are eligible for inclusion if (1) the primary cT3-cT4 gastric tumour including regional lymph nodes is considered to be resectable, (2) limited peritoneal carcinomatosis (<7) and/ or tumour positive cytology is confirmed by laparoscopy or laparotomy, and (3) systemic chemotherapy (prior to inclusion) was without disease progression.
Main study parameters/endpoints: The study sample size (182 patients) is calculated from the hypothesis that the median overall survival of the patients treated according to protocol in the experimental arm is 18 months, as compared to a median overall survival of 10 months in the standard arm. Statistical analysis will be done according to the intention-to-treat principle.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 1:1 randomization
| Arm | Type | Receives |
|---|---|---|
| Gastrecomy + Cytoreductive surgery + HIPEC | Experimental | Procedure: Cytoreductive surgery + Gastrecomy, Drug: Hyperthermic Intraperitoneal Chemotherapy (HIPEC)Gastrectomy combined with cytoreductive surgery and HIPEC (experimental treatment) |
| palliative systemic chemotherapy | No intervention | –Palliative systemic chemotherapy only (standard treatment) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Age ≥ 18 years
- Biopsy proven primary adenocarcinoma (or undifferentiated carcinoma) of the stomach. Including tumours at the oesophagogastric junction provided that the bulk of the tumour is located in the stomach, and, the intended surgical treatment is a gastric resection and not an oesophagectomy. A high intra-thoracic anastomosis is allowed, but not if a thoracotomy is necessary.
- cT3-cT4 tumour (TNM classification, 7th edition), considered to be resectable (including lymph nodes)
- Limited peritoneal carcinomatosis (PCI <7) and/ or tumour positive peritoneal cytology confirmed by laparoscopy or laparotomy and proven by pathological examination
- Treatment with systemic chemotherapy, with the latest course ending within 8 weeks prior to inclusion. All currently standard chemotherapy regimens are acceptable
Key exclusion criteria (10 listed)
- Distant metastases (e.g., liver, lung, para-aortic lymph nodes; i.e., stations 14 and 16) or small bowel dissemination
- Recurrent gastric cancer
- Prior resection of the primary gastric tumour
- Non-synchronous peritoneal carcinomatosis
- Current other malignancy (other than cervix carcinoma and basalioma)
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 |
|---|---|---|
| Cytoreductive surgery + GastrecomyComplete cytoreduction followed by a (sub)total gastric resection with D2 lymphadenectomy. | Procedure or surgery | Gastrecomy + Cytoreductive surgery + HIPEC |
| Hyperthermic Intraperitoneal Chemotherapy (HIPEC)Also: HIPECHIPEC: perfusion with oxaliplatin (460mg/m2 ) (42 °C) followed by docetaxel (50mg/m2 ) (37°C) | Drug | Gastrecomy + Cytoreductive surgery + HIPEC |
Primary outcome
overall survival
Time frame: 5 years
To compare the overall survival between gastric cancer patients with limited peritoneal carcinomatosis and/ or tumour positive peritoneal cytology treated with gastrectomy, cytoreductive surgery and HIPEC and those treated with the current standard treatment, i.e. palliative systemic chemotherapy.
3 secondary outcomes
progression free survival
Time frame: 5 years
treatment-related toxicity
Time frame: 5 years
costs and health benefits
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2025.
- Background: PubMed 28705789van der Kaaij RT, Braam HJ, Boot H, Los M, Cats A, Grootscholten C, Schellens JH, Aalbers AG, Huitema AD, Knibbe CA, Boerma D, Wiezer MJ, van Ramshorst B, van Sandick JW. Treatment of Peritoneal Dissemination in Stomach Cancer Patients With Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy (HIPEC): Rationale and Design of the PERISCOPE Study. JMIR Res Protoc. 2017 Jul 13;6(7):e136. doi: 10.2196/resprot.7790.
- Derived from this study: PubMed 42419336Quik JSE, Vollebergh MA, Retel VP, van der Sluis K, Koemans WJ, van der Kaaij RT, Voets MM, Luyer MDP, van Hellemond IEG, Wijnhoven BPL, Mostert B, van Hillegersberg R, Mohammad NH, van Etten B, de Groot DJ, Helminen O, Hedberg J, Cashin PH, Harbjerg JL, Veenhof AAFA, Hartemink KJ, Kodach LL, van der Noort V, van Sandick JW; PERISCOPE II consortium. Systemic therapy, gastrectomy, cytoreductive surgery, and hyperthermic intraperitoneal chemotherapy versus systemic therapy alone for gastric cancer with limited peritoneal metastases (PERISCOPE II): final results of a multicentre, randomised, controlled, phase 3 trial after an unplanned commissioned interim analysis. Lancet Oncol. 2026 Aug;27(8):1031-1042. doi: 10.1016/S1470-2045(26)00144-0. Epub 2026 Jul 8.
- Derived from this study: PubMed 37916797Rijken A, Pape M, Simkens GA, de Hingh IHJT, Luyer MDP, van Sandick JW, van Laarhoven HWM, Verhoeven RHA, van Erning FN. Peritoneal metastases from gastric cancer in a nationwide cohort: Incidence, treatment and survival. Int J Cancer. 2024 Mar 15;154(6):992-1002. doi: 10.1002/ijc.34780. Epub 2023 Nov 2.
- Derived from this study: PubMed 31060544Koemans WJ, van der Kaaij RT, Boot H, Buffart T, Veenhof AAFA, Hartemink KJ, Grootscholten C, Snaebjornsson P, Retel VP, van Tinteren H, Vanhoutvin S, van der Noort V, Houwink A, Hahn C, Huitema ADR, Lahaye M, Los M, van den Barselaar P, Imhof O, Aalbers A, van Dam GM, van Etten B, Wijnhoven BPL, Luyer MDP, Boerma D, van Sandick JW. Cytoreductive surgery and hyperthermic intraperitoneal chemotherapy versus palliative systemic chemotherapy in stomach cancer patients with peritoneal dissemination, the study protocol of a multicentre randomised controlled trial (PERISCOPE II). BMC Cancer. 2019 May 6;19(1):420. doi: 10.1186/s12885-019-5640-2.
- Individual participant dataSharing planned: No
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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.
Johanna van Sandick, MD, PHD principal investigator
Surgeon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cytoreductive surgery + Gastrecomy and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in people with Stomach Neoplasm and Peritoneal Carcinomatosis, run by The Netherlands Cancer Institute 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 17 inclusion and 10 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: under way, not looking for participants, as of the sponsor's last update on 17 Jul 2025. 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.
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?
This study is still under way. Results are not available in the source record yet.
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?
overall survival (time frame: 5 years). 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 NCT03348150, 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 17 Jul 2025.