Gastric CancerPhase 2GastroDOCNCT01876927
Pre-Operative Or Peri-Operative Dox Regimen In Patients With Locally Advanced Resectable Gastric Cancer
A Phase 2 study testing DOX 4 cycles - Surgery and DOX 2 cycles - Surgery - DOX 2 cycles in people with Gastric Cancer and Locally Advanced Malignant Neoplasm, run by Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS at 20 sites in Italy.
Trial summary
Study design: Multicenter, randomized, open label phase II study Arm A: DOX 4 cycles - Surgery - Follow-up Arm B: DOX 2 cycles - Surgery - DOX 2 cycles - Follow-up Population: Male or female, 18-75 years of age, with a diagnosis of histologically confirmed, potentially resectable adenocarcinoma of the stomach. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastric Cancer, Locally Advanced Malignant Neoplasm
- What is being tested?
- DOX 4 cycles - Surgery and DOX 2 cycles - Surgery - DOX 2 cycles
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 20 sitesItaly
- Study dates
- Sep 2010to 15 Sep 2022
- Phase
- Phase 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed written informed consents
- Male or female 18-75 years of age
- Diagnosis of histologically confirmed, potentially resectable adenocarcinoma of the stomach
- cT3 subserosal - cT4a - cT4b (7th edition UICC TNM) or bulky lymph node metastases independently of T
- ECOG performance status of 0-1 at study entry
- Laboratory requirements (≤ 7 days prior chemotherapy start):
Show all 12Show fewer
- Hematology:
- Neutrophils > 1.5 x 109 /L II) Platelets > 100 x 109 /L III) Hemoglobin > 10g/dL
- Hepatic function I) Total bilirubin < 1.25 UNL II) AST (SGOT) and ALT (SGPT) < 2.5xUNL III) Alkaline phosphatase < 2.5xUNL
- Renal function I) Creatinine <1.5 UNL In the event of border-line values, the calculated creatinine clearance should be > 60 mL/min;
- Written informed consent signed and dated before randomization procedures, including expected cooperation of patients for treatment and follow-up, must be obtained and documented according to local regulatory requirements.
- Effective contraception for both male and female patients if the risk of conception exists
Who cannot join
- Early gastric cancer (if N0)
- T2 (according to 7th edition of UICC TNM) if N0
- Linitis plastica
- Positive peritoneal cytology
- Distant metastases
- Neoplasm involving the gastro-esophageal junction
Show all 17Show fewer
- Pertoneal involvement
- Concurrent chronic systemic immune therapy
- Any investigational agent(s) administered 4 weeks prior to entry
- Clinically relevant coronary artery disease, a history of myocardial infarction or of hypertension not controlled by therapy within the last 12 months
- Known grade 3 or 4 allergic reaction to any of the components of the treatment
- Known drug abuse/alcohol abuse
- Legal incapacity or limited legal capacity
- Medical or psychological condition which, in the opinion of the investigator, would not permit the patient to complete the study or sign meaningful informed consent
- Women who are pregnant or breastfeeding
- Acute or subacute intestinal occlusion
- Any concurrent malignancy other than non-melanoma skin cancer, or carcinoma in situ of the cervix. (Patients with a previous malignancy but without evidence of disease for ≥ 5 years will be allowed to enter the trial)
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
Italy20 sites
Azienda Ospedaliero - Universitaria Ospedali Riuniti Umberto I - GM Lancisi
Ancona, AN
USL 8 Arezzo - Presidio Ospedaliero Zona Casentino - Ospedale di Bibbiena
Bibbiena, AR
UO Oncologia , Spedali Civili di Brescia
Brescia, BS, 25123
Ospedale Bufalini
Cesena, FC
UOC Oncologia , Azienda USL 11
Empoli, FI, 50053
Ospedale Careggi
Florence, FI
UO oncologia medica IRCCS IRST
Meldola (FC), FC, 47014
UO ONCOLOGIA , Istituto Europeo di Oncologia
Milan, MI, 20141
USL 8 Arezzo - Ospedale "Santa Maria alla Gruccia"
Montevarchi, AR
UO Oncologia, Fondazione Policlinico San Matteo
Pavia, PV, 27100
Azienda Ospedaliera di Perugia - Ospedale S. Maria della Misericordia
Perugia
Azienda Ospedaliera Universitaria Pisana
Pisa, PI
UO Oncologia Medica, PO Rimini, AUSL della Romagna
Rimini, RI, 47923
Ospedale San Filippo Neri
Roma
Istituto Clinico Humanitas
Rozzano, MI
UO Oncologia , Casa di Cura Tortorella
Salerno, SA, 84122
Policlinico Le Scotte
Siena, SI
UO Oncologia, Azienda Ospedaliero Treviglio
Treviglio, TV, 24047
UO Oncologia Medica, azienda Ospedaliera di Varese
Varese, VA, 21100
Ospedale Borgo Trento
Verona
About this study
Official title: A Randomised Phase Ii Study Of Pre-Operative Or Peri-Operative Docetaxel, Oxaliplatin, Capecitabine (Dox) Regimen In Patients With Locally Advanced Resectable Gastric Cancer
Study design:
Multicenter, randomized, open label phase II study Arm A: DOX 4 cycles - Surgery - Follow-up Arm B: DOX 2 cycles - Surgery - DOX 2 cycles - Follow-up
Read more
Population:
Male or female, 18-75 years of age, with a diagnosis of histologically confirmed, potentially resectable adenocarcinoma of the stomach.
Sample Size: Planned sample size is 90 patients, 45 patients for each arm (p0=50%, p1=80%, alpha=0.05 (two sides), beta=0.2)
Treatment Plan:
Treatment will be administered for 4 and 2 cycles before surgery in arm A and B, respectively, and in arm B for a further 2 cycles after surgery unless progression or unacceptable toxicity occurs, or a patient refuses treatment. In such cases patients will go off treatment. 3-6 weeks after the end of the fourth (arm A) or second (arm B) preoperative cycle, patients will undergo surgery.
After surgery 3-6 weeks from surgery patients in arm B will receive 2 more cycles.
DOX: Docetaxel 35 mg/m2 day 1 and 8 Oxaliplatin 80 mg/m2 day 1 Capecitabine 750 mg/m2 x 2 daily for 2 weeks
Cycles repeated every 3 weeks
Evaluation criteria: Tumor assessment will be performed according to the RECIST criteria (version 1.1).
Duration of Study:
Overall study duration: 07/2010- 03/2017 Planned study duration per patient: 5 years
Read the detailed description
Title: A randomised phase II study of pre-operative or peri-operative docetaxel, oxaliplatin, capecitabine (DOX) regimen in patients with locally advanced resectable gastric cancer.
Clinical Phase: II
Study Objectives:
Primary:
The percentage of patients receiving all the planned chemotherapeutic cycles.
Secondary:
- Downstaging according to Recist criteria
- pT1-3 vs pT0.
- Safety: number of patients with grade 3-4 toxicity
- The role of PET Scan as predictor of response
- Curative vs palliative surgery
- TTP
- OS
- Diagnostic correlation between the various staging methods
- Possible correlations between CT scan, CT/PET, laparoscopy;
- Molecular markers related to toxicity: DPYD, MTHFR, TS, XPD, ERCC1, XRCC1;
- Molecular markers related to prognosis: TYMS, GSTP1, COX-2, RUNX3, methylation profile (Cox2, hMLH1, MGMT);
- Molecular markers related to therapy response: TYMS, DPYD, MTHFR, OPRT, ERCC1, XRCC1/2/3, GSTP1, GSTM1, GSTT1, ABCB1, methylation profile (Cox2, hMLH1, MGMT), whole genome arrayCGH.
Study design:
Multicenter, randomized, open label phase II study Arm A: DOX 4 cycles - Surgery - Follow-up Arm B: DOX 2 cycles - Surgery - DOX 2 cycles - Follow-up
Population:
Male or female, 18-75 years of age, with a diagnosis of histologically confirmed, potentially resectable adenocarcinoma of the stomach.
Sample Size: Planned sample size is 90 patients, 45 patients for each arm (p0=50%, p1=80%, alpha=0.05 (two sides), beta=0.2)
Treatment Plan:
Treatment will be administered for 4 and 2 cycles before surgery in arm A and B, respectively, and in arm B for a further 2 cycles after surgery unless progression or unacceptable toxicity occurs, or a patient refuses treatment. In such cases patients will go off treatment. 3-6 weeks after the end of the fourth (arm A) or second (arm B) preoperative cycle, patients will undergo surgery.
After surgery 3-6 weeks from surgery patients in arm B will receive 2 more cycles.
DOX: Docetaxel 35 mg/m2 day 1 and 8 Oxaliplatin 80 mg/m2 day 1 Capecitabine 750 mg/m2 x 2 daily for 2 weeks
Cycles repeated every 3 weeks
Evaluation criteria: Tumor assessment will be performed according to the RECIST criteria (version 1.1).
Duration of Study:
Overall study duration: 07/2010- 03/2017 Planned study duration per patient: 5 years
- Being tested
- DOX 4 cycles - Surgery, DOX 2 cycles - Surgery - DOX 2 cycles
- Keywords
- Locally, Advanced, Resectable, Gastric Cancer
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DOX 4 cycles - SurgeryOther
DOX 4 cycles - Surgery
DOX 2 cycles - Surgery - DOX 2 cyclesOther
DOX 2 cycles - Surgery - DOX 2 cycles
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | DOX 4 cycles - Surgery - Follow-up
DOX:
Docetaxel 35 mg/m2 day 1 and 8 by one hour infusion; Oxaliplatin 80 mg/m2 day 1 by two hours infusion; Capecitabine 750 mg/m2 x 2 daily for 2 weeks, per OS.
Treatment should be administered for 4 cycles before surgery. Each cycle will be repeated every 3 weeks. Receives: Other: DOX 4 cycles - Surgery |
| Arm B | Experimental | DOX 2 cycles - Surgery - DOX 2 cycles - Follow-up
DOX:
Docetaxel 35 mg/m2 day 1 and 8 by one hour infusion; Oxaliplatin 80 mg/m2 day 1 by two hours infusion; Capecitabine 750 mg/m2 x 2 daily for 2 weeks, per OS.
Treatment should be administered for 2 cycles before surgery and for further 2 cycles after surgery, unless progression of disease or unacceptable toxicity occurs, or patient refusal. In these cases patients will go off treatment.
Each cycle will be repeated every 3 weeks. Receives: Other: DOX 2 cycles - Surgery - DOX 2 cycles |
What is being measured
The primary outcome is the main question the study is designed to answer.
the difference in percentage of patients receiving all the planned chemotherapeutic cycles between the two arms.
Measured: 7 years
Secondary outcomes (11)
The percentage of tumors downstaged at the diagnosis
To determine the percentage of tumors downstaged at the diagnosis, compared with the pathological stage detected at the time of surgery (according to Recist criteria)
Measured: 7 years
Treatment tolerability and safety and tumor response in patients with pathological stage pT1-3 vs pT0
Comparation of treatment tolerability and safety and tumor response between patients with pathological stage pT1-3 vs pT0 (detected at the time of surgery)
Measured: 7 years
Number of patients with adverse events of grade 3-4 as a measure of safety and tolerability
Measured: 7 years
Diagnostic capability of PET
Evaluation of the role of PET as a tool to detect tumor response
Measured: 7 years
Efficacy comparation between curative vs palliative surgery
Measured: 7 years
Time to progression
Measured: 7 years
Overall survival
Measured: 7 years
Diagnostic capability of CT scan, CT/PET and laparoscopy
Evaluation of possible correlations between the diagnostic techniques CT scan, CT/PET and laparoscopy
Measured: 7 years
Biological profile of treatment toxicity
Biological detection of molecular markers related to treatment toxicity (DPYD, MTHFR, TS, XPD, ERCC1, XRCC1)
Measured: 7 years
Biological profile of treatment prognosis
Biological detection of molecular markers related to treatment prognosis (TYMS, GSTP1, COX-2, RUNX3, methylation profile (Cox2, hMLH1, MGMT))
Measured: 7 years
Biologcal profile of treatment response
Biological detection of molecular markers related to therapy response (TYMS, DPYD, MTHFR, OPRT, ERCC1, XRCC1/2/3, GSTP1, GSTM1, GSTT1, ABCB1, methylation profile (Cox2, hMLH1, MGMT), whole genome arrayCGH)
Measured: 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2013 (estimated)
- Study startSep 2010
- Primary completionMar 2017
- Study completion15 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Manlio Monti, MD, Principal investigator, IRST IRCCS, Meldola
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01876927
- Sponsor's protocol ID
- IRST151.01
- Other IDs
- 2010-020189-37
- Acronym
- GastroDOC
- Status last verified
- Jan 2025
- First submitted
- 7 Jun 2013
- Last updated
- 9 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Phase Ii Study Of Pre-Operative Or Peri-Operative Docetaxel, Oxaliplatin, Capecitabine (Dox) Regimen In Patients With Locally Advanced Resectable Gastric Cancer
- ClinicalTrials.gov ID
- NCT01876927
- Acronym / sponsor ID
- GastroDOC / IRST151.01
- Keywords
- Locally, Advanced, Resectable, Gastric Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCSUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Mar 2017 (actual)
- Study completion
- 15 Sep 2022 (actual)
- First posted
- 13 Jun 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.
Study design:
Multicenter, randomized, open label phase II study Arm A: DOX 4 cycles - Surgery - Follow-up Arm B: DOX 2 cycles - Surgery - DOX 2 cycles - Follow-up
Population:
Male or female, 18-75 years of age, with a diagnosis of histologically confirmed, potentially resectable adenocarcinoma of the stomach.
Sample Size: Planned sample size is 90 patients, 45 patients for each arm (p0=50%, p1=80%, alpha=0.05 (two sides), beta=0.2)
Treatment Plan:
Treatment will be administered for 4 and 2 cycles before surgery in arm A and B, respectively, and in arm B for a further 2 cycles after surgery unless progression or unacceptable toxicity occurs, or a patient refuses treatment. In such cases patients will go off treatment. 3-6 weeks after the end of the fourth (arm A) or second (arm B) preoperative cycle, patients will undergo surgery.
After surgery 3-6 weeks from surgery patients in arm B will receive 2 more cycles.
DOX: Docetaxel 35 mg/m2 day 1 and 8 Oxaliplatin 80 mg/m2 day 1 Capecitabine 750 mg/m2 x 2 daily for 2 weeks
Cycles repeated every 3 weeks
Evaluation criteria: Tumor assessment will be performed according to the RECIST criteria (version 1.1).
Duration of Study:
Overall study duration: 07/2010- 03/2017 Planned study duration per patient: 5 years
Detailed description
Title: A randomised phase II study of pre-operative or peri-operative docetaxel, oxaliplatin, capecitabine (DOX) regimen in patients with locally advanced resectable gastric cancer.
Clinical Phase: II
Study Objectives:
Primary:
The percentage of patients receiving all the planned chemotherapeutic cycles.
Secondary:
- Downstaging according to Recist criteria
- pT1-3 vs pT0.
- Safety: number of patients with grade 3-4 toxicity
- The role of PET Scan as predictor of response
- Curative vs palliative surgery
- TTP
- OS
- Diagnostic correlation between the various staging methods
- Possible correlations between CT scan, CT/PET, laparoscopy;
- Molecular markers related to toxicity: DPYD, MTHFR, TS, XPD, ERCC1, XRCC1;
- Molecular markers related to prognosis: TYMS, GSTP1, COX-2, RUNX3, methylation profile (Cox2, hMLH1, MGMT);
- Molecular markers related to therapy response: TYMS, DPYD, MTHFR, OPRT, ERCC1, XRCC1/2/3, GSTP1, GSTM1, GSTT1, ABCB1, methylation profile (Cox2, hMLH1, MGMT), whole genome arrayCGH.
Study design:
Multicenter, randomized, open label phase II study Arm A: DOX 4 cycles - Surgery - Follow-up Arm B: DOX 2 cycles - Surgery - DOX 2 cycles - Follow-up
Population:
Male or female, 18-75 years of age, with a diagnosis of histologically confirmed, potentially resectable adenocarcinoma of the stomach.
Sample Size: Planned sample size is 90 patients, 45 patients for each arm (p0=50%, p1=80%, alpha=0.05 (two sides), beta=0.2)
Treatment Plan:
Treatment will be administered for 4 and 2 cycles before surgery in arm A and B, respectively, and in arm B for a further 2 cycles after surgery unless progression or unacceptable toxicity occurs, or a patient refuses treatment. In such cases patients will go off treatment. 3-6 weeks after the end of the fourth (arm A) or second (arm B) preoperative cycle, patients will undergo surgery.
After surgery 3-6 weeks from surgery patients in arm B will receive 2 more cycles.
DOX: Docetaxel 35 mg/m2 day 1 and 8 Oxaliplatin 80 mg/m2 day 1 Capecitabine 750 mg/m2 x 2 daily for 2 weeks
Cycles repeated every 3 weeks
Evaluation criteria: Tumor assessment will be performed according to the RECIST criteria (version 1.1).
Duration of Study:
Overall study duration: 07/2010- 03/2017 Planned study duration per patient: 5 years
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Other: DOX 4 cycles - SurgeryDOX 4 cycles - Surgery - Follow-up DOX: Docetaxel 35 mg/m2 day 1 and 8 by one hour infusion; Oxaliplatin 80 mg/m2 day 1 by two hours infusion; Capecitabine 750 mg/m2 x 2 daily for 2 weeks, per OS. Treatment should be administered for 4 cycles before surgery. Each cycle will be repeated every 3 weeks. |
| Arm B | Experimental | Other: DOX 2 cycles - Surgery - DOX 2 cyclesDOX 2 cycles - Surgery - DOX 2 cycles - Follow-up DOX: Docetaxel 35 mg/m2 day 1 and 8 by one hour infusion; Oxaliplatin 80 mg/m2 day 1 by two hours infusion; Capecitabine 750 mg/m2 x 2 daily for 2 weeks, per OS. Treatment should be administered for 2 cycles before surgery and for further 2 cycles after surgery, unless progression of disease or unacceptable toxicity occurs, or patient refusal. In these cases patients will go off treatment. Each cycle will be repeated every 3 weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Signed written informed consents
- Male or female 18-75 years of age
- Diagnosis of histologically confirmed, potentially resectable adenocarcinoma of the stomach
- cT3 subserosal - cT4a - cT4b (7th edition UICC TNM) or bulky lymph node metastases independently of T
- ECOG performance status of 0-1 at study entry
Key exclusion criteria (17 listed)
- Early gastric cancer (if N0)
- T2 (according to 7th edition of UICC TNM) if N0
- Linitis plastica
- Positive peritoneal cytology
- Distant metastases
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 |
|---|---|---|
| DOX 4 cycles - SurgeryDOX 4 cycles - Surgery | Other | Arm A |
| DOX 2 cycles - Surgery - DOX 2 cyclesDOX 2 cycles - Surgery - DOX 2 cycles | Other | Arm B |
Primary outcome
the difference in percentage of patients receiving all the planned chemotherapeutic cycles between the two arms.
Time frame: 7 years
11 secondary outcomes
The percentage of tumors downstaged at the diagnosis
Time frame: 7 years
Treatment tolerability and safety and tumor response in patients with pathological stage pT1-3 vs pT0
Time frame: 7 years
Number of patients with adverse events of grade 3-4 as a measure of safety and tolerability
Time frame: 7 years
Diagnostic capability of PET
Time frame: 7 years
Efficacy comparation between curative vs palliative surgery
Time frame: 7 years
Time to progression
Time frame: 7 years
Overall survival
Time frame: 7 years
Diagnostic capability of CT scan, CT/PET and laparoscopy
Time frame: 7 years
Biological profile of treatment toxicity
Time frame: 7 years
Biological profile of treatment prognosis
Time frame: 7 years
Biologcal profile of treatment response
Time frame: 7 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2025.
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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.
Manlio Monti, MD principal investigator
IRST IRCCS, Meldola
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DOX 4 cycles - Surgery and DOX 2 cycles - Surgery - DOX 2 cycles in people with Gastric Cancer and Locally Advanced Malignant Neoplasm, run by Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS at 20 sites in Italy.
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 12 inclusion and 17 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: finished, as of the sponsor's last update on 9 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Italy. 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
the difference in percentage of patients receiving all the planned chemotherapeutic cycles between the two arms. (time frame: 7 years). 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 9 Jan 2025.