Fallopian Tube Endometrioid AdenocarcinomaEarly Phase 1NCT05415709
Hyperthermic Intraperitoneal Chemotherapy With Cisplatin During Surgery or Cisplatin Before Surgery for the Treatment of Stage III or IV Ovarian, Fallopian Tube or Peritoneal Cancer
A Early Phase 1 study testing Carboplatin, Cisplatin and Cytoreductive Surgery in people with Fallopian Tube Endometrioid Adenocarcinoma and Fallopian Tube Mucinous Adenocarcinoma, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
Trial summary
This phase I trial studies the side effects of hyperthermic intraepithelial chemotherapy with cisplatin after surgery or cisplatin before surgery in treating patients with stage III or IV ovarian, fallopian tube or peritoneal cancer receiving chemotherapy before surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fallopian Tube Endometrioid Adenocarcinoma, Fallopian Tube Mucinous Adenocarcinoma, Fallopian Tube Serous Adenocarcinoma
- What is being tested?
- Carboplatin, Cisplatin and Cytoreductive Surgery
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jun 2022to 31 Dec 2026
- Phase
- Early Phase 1
- 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
- Ability to understand (English-speaking), and willingness to sign a written, informed consent
- Age > 18 years old
- Newly diagnosed stage III or IV epithelial (serous, mucinous, or endometrioid) ovarian, fallopian tube or peritoneal cancer diagnosed by:
- Biopsy/histology (either by interventional radiology or laparoscopy) OR
- Cytology; If diagnosis is based on cytology the following criteria must be met:
- Immunohistochemistry on the block from cytology to demonstrate Mullerian origin
Show all 23Show fewer
- Presence of pelvic mass AND CA 125 > 200kU/I AND CA125/CEA ratio > 25 at initial diagnosis
- Omental cake or other metastases larger than 2 cm in the upper abdomen and/or regional lymph node metastasis irrespective of size (diagnosed by computed tomography [CT]/magnetic resonance imaging [MRI], ultrasound, or laparoscopy)
- Patient planned for or currently receiving neoadjuvant chemotherapy due to the fact that optimal primary CRS was determined not to be feasible by the primary surgeon
- Patient must be planned or scheduled to undergo interval cytoreductive surgery after cycle 3-4 of neoadjuvant surgery
- Completion of three cycles of neoadjuvant chemotherapy (NACT) with standard therapy (carboplatin [area under the curve (AUC) 5-6] day [D]1 + paclitaxel [175 mg/m^2] D1 every 3 weeks)
- Following 3-4 cycles of NACT partial or complete response
- Following 3-4 cycles of NACT at least 50% decrease in CA-125 level between pre-cycle 1 and post-cycle 3/prior to surgery
- Fit for major surgery, American Society of Anesthesiologists (ASA )1 or ASA 2
- Eastern Cooperative Oncology Group (ECOG) performance-status score of 0-2
- Serum creatinine < 1.4 mg/dL
- Creatinine clearance > 60 ml/min (Cockcroft-Gault formula)
- White blood cell count > 3.5 x 10^9 cells/L
- Absolute neutrophil count > 1.5 kg/ul
- Platelets > 100,000/ul
- Total bilirubin within 1.5 x normal institutional limits
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x institutional upper limit of normal
- For quality of life assessment, baseline questionnaires should be filled in before randomization
Who cannot join
- History of breast cancer or previous malignancy within 5 years prior to inclusion, with the exception of radically excised basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
- Low grade serious carcinoma of the ovary or borderline ovarian tumors
- History or current diagnosis of inflammatory bowel disease
- History of allergic reactions to compounds of similar chemical or biologic composition to cisplatin, carboplatin, and paclitaxel
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia
- Patients in whom an optimal or complete cytoreduction cannot be performed will be excluded at the time of surgery and be replaced
Trial locations and contacts
1 site in 1 country.
United States1 site
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
About this study
Official title: Randomized Phase I Study Assessing the Safety and Tolerability Hyperthermic Intraperitoneal Chemotherapy (HIPEC) at Completion of Interval Cytoreductive Surgery Compared to Surgery and Chemotherapy Prior to Surgery for Patients With Stage III/IV Ovarian Cancer Undergoing Neoadjuvant Chemotherapy.
This phase I trial studies the side effects of hyperthermic intraepithelial chemotherapy with cisplatin after surgery or cisplatin before surgery in treating patients with stage III or IV ovarian, fallopian tube or peritoneal cancer receiving chemotherapy before surgery. Hyperthermic intraepithelial chemotherapy involves the infusion of heated cytotoxic chemotherapy that circulates into the abdominal cavity at the time of surgery. Chemotherapy drugs, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving hyperthermic intraepithelial chemotherapy with cisplatin after surgery or cisplatin before surgery may kill more tumor cells compared to usual care.
Read the detailed description
PRIMARY OBJECTIVES:
- To evaluate the safety and tolerability of intravenous (IV) cisplatin on the day prior to interval cytoreductive surgery (CRS) to administration of hyperthermic intraepithelial chemotherapy (HIPEC) with cisplatin at the completion of interval cytoreductive surgery.
SECONDARY OBJECTIVES:
- Feasibility of each of the treatment options. II. Treatment delays. III. Perioperative outcomes. IV. Quality of life/patient reported outcomes. V. Recurrence free survival (RFS) and overall survival (OS). VI. Changes to the gut MIcrobiome
OUTLINE:
Patients receive carboplatin IV and paclitaxel IV on day 1. Treatment repeats every 3 weeks for 3-4 cycles in the absence of disease progression or unacceptable toxicity. Within 3-4 weeks following the third or fourth neoadjuvant cycle, patients who achieve complete or partial response undergo interval debulking surgery
Patients are randomized to 1 of 2 arms.
ARM I: Patients receive cisplatin IV the day prior to interval cytoreductive surgery
ARM II: Patients undergo HIPEC and receive cisplatin IV over 90 minutes at the time of interval cytoreductive surgery
All patients undergo stool sample collection and diagnostic imaging throughout the trial.
After completion of study treatment, patients are followed up for up to 30 days.
- Conditions
- Fallopian Tube Endometrioid Adenocarcinoma, Fallopian Tube Mucinous Adenocarcinoma, Fallopian Tube Serous Adenocarcinoma, Ovarian Endometrioid Adenocarcinoma, Ovarian Mucinous Adenocarcinoma, Ovarian Serous Adenocarcinoma
- Being tested
- Carboplatin, Cisplatin, Cytoreductive Surgery, Hyperthermic Intraperitoneal Chemotherapy, Paclitaxel
- Medical subject headings
- Fallopian Tube Neoplasms, Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CarboplatinDrug
Also called Blastocarb, Carboplat, Carboplatin Hexal, Carboplatino
Given IV
CisplatinDrug
Also called Abiplatin, Blastolem, Briplatin, CDDP
Given IV
Cytoreductive SurgeryProcedure or surgery
Also called Cytoreduction
Undergo CRS
Hyperthermic Intraperitoneal ChemotherapyDrug
Also called HIPEC
Undergo HIPEC
PaclitaxelDrug
Also called Anzatax, Asotax, Bristaxol, Praxel
Given IV
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
Biospecimen CollectionProcedure or surgery
Undergo stool sample collection
Diagnostic ImagingProcedure or surgery
Also called Medical Imaging
Undergo diagnostic imaging
| Study group | Role | What they receive |
|---|---|---|
| Arm I (carboplatin, paclitaxel, CRS, cisplatin) | Experimental | OUTLINE:
Patients receive carboplatin IV and paclitaxel IV on day 1. Treatment repeats every 3 weeks for 3-4 cycles in the absence of disease progression or unacceptable toxicity. Within 3-4 weeks following the third or fourth neoadjuvant cycle, patients who achieve complete or partial response undergo interval cytoreductive surgery (CRS)
Patients are randomized to 1 of 2 arms.
ARM II: Patients receive cisplatin IV the day prior to CRS Patients undergo stool sample collection and diagnostic imaging throughout the trial. Receives: Drug: Carboplatin; Drug: Cisplatin; Procedure: Cytoreductive Surgery; Drug: Paclitaxel; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Procedure: Biospecimen Collection; Procedure: Diagnostic Imaging |
| Arm II (carboplatin, paclitaxel, CRS, HIPEC, cisplatin) | Experimental | OUTLINE:
Patients receive carboplatin IV and paclitaxel IV on day 1. Treatment repeats every 3 weeks for 3-4 cycles in the absence of disease progression or unacceptable toxicity. Within 3-4 weeks following the third or fourth neoadjuvant cycle, patients who achieve complete or partial response undergo interval cytoreductive surgery (CRS)
Patients are randomized to 1 of 2 arms.
ARM II: Patients undergo HIPEC and receive cisplatin IV over 90 minutes at the time of CRS Patients undergo stool sample collection and diagnostic imaging throughout the trial. Receives: Drug: Carboplatin; Drug: Cisplatin; Procedure: Cytoreductive Surgery; Drug: Hyperthermic Intraperitoneal Chemotherapy; Drug: Paclitaxel; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Procedure: Biospecimen Collection; Procedure: Diagnostic Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of chemotherapy-related adverse events
Defined by Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0.
Measured: 30 days from perioperative treatment
Secondary outcomes (6)
Feasibility of chemotherapy immediately perioperatively
Percentage of patients able to receive planned chemotherapy the day prior to surgery or HIPEC on day of surgery
Measured: 1 Day prior to surgery and 1 day of surgery
Percentage of patients in Arm C with a treatment free interval of < 8 weeks
Percentage of patients in Arm C with a treatment free interval of < 8 weeks
Measured: Up to 1 year
Recurrence free survival
time between surgery and recurrence
Measured: For 3-5 years after study
Tumor response
tumor response evaluated per clinical standards
Measured: Up to 1 year
Quality of life (QOL) assessment EORTC QLQ-C30
Validated quality of life assessments
Measured: Baseline up to 6 months post-treatment
Changes to the gut microbiome
metagenomic whole-genome shotgun sequencing (mWGS)
Measured: Within one week of re-operative appointment, cycle 1 (each cycle is 28 days) of adjuvant chemotherapy and last cycle of adjuvant chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2022
- Study start13 Jun 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fallopian Tube Endometrioid AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Ohio State University Comprehensive Cancer CenterThe 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Floor Backes, MD, Ohio State University Comprehensive Cancer Center
- Investigators
- Floor Backes, MD, Principal investigator, Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05415709
- Sponsor's protocol ID
- OSU-20277
- Other IDs
- NCI-2021-06207
- Status last verified
- Aug 2026
- First submitted
- 5 Apr 2022
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Phase I Study Assessing the Safety and Tolerability Hyperthermic Intraperitoneal Chemotherapy (HIPEC) at Completion of Interval Cytoreductive Surgery Compared to Surgery and Chemotherapy Prior to Surgery for Patients With Stage III/IV Ovarian Cancer Undergoing Neoadjuvant Chemotherapy.
- ClinicalTrials.gov ID
- NCT05415709
- Acronym / sponsor ID
- OSU-20277
- Conditions
- Fallopian Tube Endometrioid Adenocarcinoma, Fallopian Tube Mucinous Adenocarcinoma, Fallopian Tube Serous Adenocarcinoma, Ovarian Endometrioid Adenocarcinoma, Ovarian Mucinous Adenocarcinoma, Ovarian Serous Adenocarcinoma
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 13 Jun 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 13 Jun 2022 (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.
This phase I trial studies the side effects of hyperthermic intraepithelial chemotherapy with cisplatin after surgery or cisplatin before surgery in treating patients with stage III or IV ovarian, fallopian tube or peritoneal cancer receiving chemotherapy before surgery. Hyperthermic intraepithelial chemotherapy involves the infusion of heated cytotoxic chemotherapy that circulates into the abdominal cavity at the time of surgery. Chemotherapy drugs, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving hyperthermic intraepithelial chemotherapy with cisplatin after surgery or cisplatin before surgery may kill more tumor cells compared to usual care.
Detailed description
PRIMARY OBJECTIVES:
- To evaluate the safety and tolerability of intravenous (IV) cisplatin on the day prior to interval cytoreductive surgery (CRS) to administration of hyperthermic intraepithelial chemotherapy (HIPEC) with cisplatin at the completion of interval cytoreductive surgery.
SECONDARY OBJECTIVES:
- Feasibility of each of the treatment options. II. Treatment delays. III. Perioperative outcomes. IV. Quality of life/patient reported outcomes. V. Recurrence free survival (RFS) and overall survival (OS). VI. Changes to the gut MIcrobiome
OUTLINE:
Patients receive carboplatin IV and paclitaxel IV on day 1. Treatment repeats every 3 weeks for 3-4 cycles in the absence of disease progression or unacceptable toxicity. Within 3-4 weeks following the third or fourth neoadjuvant cycle, patients who achieve complete or partial response undergo interval debulking surgery
Patients are randomized to 1 of 2 arms.
ARM I: Patients receive cisplatin IV the day prior to interval cytoreductive surgery
ARM II: Patients undergo HIPEC and receive cisplatin IV over 90 minutes at the time of interval cytoreductive surgery
All patients undergo stool sample collection and diagnostic imaging throughout the trial.
After completion of study treatment, patients are followed up for up to 30 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (carboplatin, paclitaxel, CRS, cisplatin) | Experimental | Drug: Carboplatin, Drug: Cisplatin, Procedure: Cytoreductive Surgery, Drug: Paclitaxel, Other: Quality-of-Life Assessment, Other: Questionnaire Administration, Procedure: Biospecimen Collection, Procedure: Diagnostic ImagingOUTLINE: Patients receive carboplatin IV and paclitaxel IV on day 1. Treatment repeats every 3 weeks for 3-4 cycles in the absence of disease progression or unacceptable toxicity. Within 3-4 weeks following the third or fourth neoadjuvant cycle, patients who achieve complete or partial response undergo interval cytoreductive surgery (CRS) Patients are randomized to 1 of 2 arms. ARM II: Patients receive cisplatin IV the day prior to CRS Patients undergo stool sample collection and diagnostic imaging throughout the trial. |
| Arm II (carboplatin, paclitaxel, CRS, HIPEC, cisplatin) | Experimental | Drug: Carboplatin, Drug: Cisplatin, Procedure: Cytoreductive Surgery, Drug: Hyperthermic Intraperitoneal Chemotherapy, Drug: Paclitaxel, Other: Quality-of-Life Assessment, Other: Questionnaire Administration, Procedure: Biospecimen Collection, Procedure: Diagnostic ImagingOUTLINE: Patients receive carboplatin IV and paclitaxel IV on day 1. Treatment repeats every 3 weeks for 3-4 cycles in the absence of disease progression or unacceptable toxicity. Within 3-4 weeks following the third or fourth neoadjuvant cycle, patients who achieve complete or partial response undergo interval cytoreductive surgery (CRS) Patients are randomized to 1 of 2 arms. ARM II: Patients undergo HIPEC and receive cisplatin IV over 90 minutes at the time of CRS Patients undergo stool sample collection and diagnostic imaging throughout the trial. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Ability to understand (English-speaking), and willingness to sign a written, informed consent
- Age > 18 years old
- Newly diagnosed stage III or IV epithelial (serous, mucinous, or endometrioid) ovarian, fallopian tube or peritoneal cancer diagnosed by:
- Patient planned for or currently receiving neoadjuvant chemotherapy due to the fact that optimal primary CRS was determined not to be feasible by the primary surgeon
- Patient must be planned or scheduled to undergo interval cytoreductive surgery after cycle 3-4 of neoadjuvant surgery
Key exclusion criteria (6 listed)
- History of breast cancer or previous malignancy within 5 years prior to inclusion, with the exception of radically excised basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
- Low grade serious carcinoma of the ovary or borderline ovarian tumors
- History or current diagnosis of inflammatory bowel disease
- History of allergic reactions to compounds of similar chemical or biologic composition to cisplatin, carboplatin, and paclitaxel
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia
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 |
|---|---|---|
| CarboplatinAlso: Blastocarb, Carboplat, Carboplatin Hexal, CarboplatinoGiven IV | Drug | Arm I (carboplatin, paclitaxel, CRS, cisplatin), Arm II (carboplatin, paclitaxel, CRS, HIPEC, cisplatin) |
| CisplatinAlso: Abiplatin, Blastolem, Briplatin, CDDPGiven IV | Drug | Arm I (carboplatin, paclitaxel, CRS, cisplatin), Arm II (carboplatin, paclitaxel, CRS, HIPEC, cisplatin) |
| Cytoreductive SurgeryAlso: CytoreductionUndergo CRS | Procedure or surgery | Arm I (carboplatin, paclitaxel, CRS, cisplatin), Arm II (carboplatin, paclitaxel, CRS, HIPEC, cisplatin) |
| Hyperthermic Intraperitoneal ChemotherapyAlso: HIPECUndergo HIPEC | Drug | Arm II (carboplatin, paclitaxel, CRS, HIPEC, cisplatin) |
| PaclitaxelAlso: Anzatax, Asotax, Bristaxol, PraxelGiven IV | Drug | Arm I (carboplatin, paclitaxel, CRS, cisplatin), Arm II (carboplatin, paclitaxel, CRS, HIPEC, cisplatin) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Arm I (carboplatin, paclitaxel, CRS, cisplatin), Arm II (carboplatin, paclitaxel, CRS, HIPEC, cisplatin) |
| Questionnaire AdministrationAncillary studies | Other | Arm I (carboplatin, paclitaxel, CRS, cisplatin), Arm II (carboplatin, paclitaxel, CRS, HIPEC, cisplatin) |
| Biospecimen CollectionUndergo stool sample collection | Procedure or surgery | Arm I (carboplatin, paclitaxel, CRS, cisplatin), Arm II (carboplatin, paclitaxel, CRS, HIPEC, cisplatin) |
| Diagnostic ImagingAlso: Medical ImagingUndergo diagnostic imaging | Procedure or surgery | Arm I (carboplatin, paclitaxel, CRS, cisplatin), Arm II (carboplatin, paclitaxel, CRS, HIPEC, cisplatin) |
Primary outcome
Incidence of chemotherapy-related adverse events
Time frame: 30 days from perioperative treatment
Defined by Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0.
6 secondary outcomes
Feasibility of chemotherapy immediately perioperatively
Time frame: 1 Day prior to surgery and 1 day of surgery
Percentage of patients in Arm C with a treatment free interval of < 8 weeks
Time frame: Up to 1 year
Recurrence free survival
Time frame: For 3-5 years after study
Tumor response
Time frame: Up to 1 year
Quality of life (QOL) assessment EORTC QLQ-C30
Time frame: Baseline up to 6 months post-treatment
Changes to the gut microbiome
Time frame: Within one week of re-operative appointment, cycle 1 (each cycle is 28 days) of adjuvant chemotherapy and last cycle of adjuvant chemotherapy
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 Aug 2026.
- The JameslineLink provided by the sponsor.
- 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.
Floor Backes, MD principal investigator
Ohio State University Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Carboplatin, Cisplatin and Cytoreductive Surgery in people with Fallopian Tube Endometrioid Adenocarcinoma and Fallopian Tube Mucinous Adenocarcinoma, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
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 23 inclusion and 6 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 Aug 2026. 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 United States. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Incidence of chemotherapy-related adverse events (time frame: 30 days from perioperative treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.