Trial · NCT01515748
Docetaxel+Oxaliplatin+S-1 (DOS) Regimen as Neoadjuvant Chemotherapy in Advanced Gastric Cancer
NCT01515748, Phase 3, Completed, Sanofi; results first posted 2020-03-02
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Docetaxel+Oxaliplatin+S-1 (DOS) Regimen as Neoadjuvant Chemotherapy in Advanced Gastric Cancer. Trials, record NCT01515748. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01515748
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Docetaxel+Oxaliplatin+S-1 (DOS) Regimen as Neoadjuvant Chemotherapy in Advanced Gastric Cancer
- NCT number
- NCT01515748
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 530 participants, actual
- Lead sponsor
- Sanofi
- Conditions
- Gastric Cancer
- Interventions
- Docetaxel (XRP6976), Oxaliplatin (SR96669), S-1 (1-(2-tetrahydrofuryl)-5-fluorouracil + 5-chloro-2, 4-dihydroxypyridine (CDHP) (Gimeracil) + Oxo (Oteracil)
- First posted
- 2012-01-24
- Last updated
- 2023-12-13
- Results first posted
- 2020-03-02
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With 3-Year Progression-Free Survival (PFS), as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST)1.1 | 3 years | PFS was defined as the time from randomization to objective tumor progression, or recurrence or death. Progressive disease (PD) was defined as follows: 1) In Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) Arm, PD was determined according to the RECIST 1.1 Criteria during the neo-adjuvant chemotherapy period; 2) Irrespective of curative resection, if an intraoperative distant metastasis was observed or a distant metastasis was reported from pathology, it was considered PD; 3) If residual cancer cells were visually identified at the resection margin during surgery but could not be completely resected (R2), it was considered PD; 4) If residual cancer cells were finally confirmed at the resection margin during postoperative histology (R1), it was considered PD; 5) In case of finding a recurrence/distant metastasis or a new lesion during follow-up after R0 complete resection, it was defined as the first tumor assessment date when it was observed. |
| Secondary | Overall Survival (OS) | From randomization to date of death due to any cause (maximum duration: up to 10 years) | OS was defined as the time from randomization to death due to any cause. Analyzed using Kaplan-Meier method. |
| Secondary | Number of Participants With Post-Operative Pathological Stage Response | Up to 10 years | TNM pathological stage was determined according to standardized histopathology and the American Joint Committee on Cancer (AJCC) staging system 7th Edition (Stages 0,IA,IB,IIA,IIB,IIIA,IIIB,IIIC and IV). Stage 0=carcinoma in situ with no metastatic potential; Stage IA=T1N0M0; Stage IB=T2N0M0,T1N1M0; Stage IIA=T3N0M0,T2N1M0,T1N2M0;Stage IIB=T4aN0M0,T3N1M0,T2N2M0,T1N3M0;Stage IIIA=T4aN1M0,T3N2M0,T2N3M0;Stage IIIB=T4bN0-1M0,T4aN2M0,T3N3M0;Stage IIIC=T4bN2-3M0, T4aN3M0 and Stage IV= distant metastases (M1) at diagnosis; where "T" denotes "tumor size" where T1: tumor invades lamina propria, muscularis mucosae, or submucosa; T2: invades muscularis propria; T3: invasion of subserosa; T4: T4a: penetrate serosa (visceral peritoneum) T4b: invade adjacent tissue and " N" denotes "nodes affected" where N1:1-2 positive lymph nodes; N2:3-6 positive lymph nodes; N3: 7 or more positive lymph nodes and "M" denotes metastases where M0: no distant metastases. Higher stages indicates worse outcome. |
| Secondary | Percentage of Participants With R0 Resection | Up to 10 years | Tumor condition was explained according to the Residual Tumor (R) Classification: R0; No residual cancer (negative cross-section), R1; Microscopically observed residual cancer (positive cross-section), R2; Macroscopically observed residual cancer. |
| Secondary | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | From randomization up to 30 days after last dose of study drug (maximum duration: up to 10 years) | TEAEs were defined as adverse events (AE) that appeared or worsened during the treatment period (up to 30 days after the last dose of the investigational product). SAE was an AE or adverse drug reaction at any dose of the investigational product that corresponded to one of the following: resulting in death or is life threatening; requiring in-patient hospitalization or prolongation of existing hospitalization; resulting in persistent or significant disability of dysfunction; resulting in congenital anomaly or birth defect; important medical event. |
| Secondary | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade to Worst National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Grade >=3 | From Baseline up to 30 days after last dose of study drug (maximum duration: up to 10 years) | NCI-CTCAE version 4.03 was used to determine Grade(Gr),where Gr refers to severity of AE:Gr 1:mild; asymptomatic/mild symptoms; Gr 2:moderate;minimal; Gr 3:severe/medically significant; Gr 4:life-threatening consequences, Gr 5:death related to AE. Abnormal values for Hemoglobin(Hb)(Anemia) were based on Gr1:\<lower limit of normal (LLN)-10.0g/dL; Gr2:\<10.0-8.0g/dL; Gr3:\<8.0g/dL; Gr4:life-threatening consequences;Gr5:death. Hb increased:Gr 1:increase(incr.) in \>0-2g/dL above upper limit of normal(ULN);Gr2: incr. in \>2-4g/dL above ULN; Gr3:incr. in \>4gm/dL above ULN. White blood cell (WBC) decreased: Gr1:\<LLN - 3000/mm\^3;Gr2: \<3000-2000/mm\^3; Gr3:\<2000-1000/mm\^3;Gr4:\<1000/mm\^3. WBC (Leukocytosis):Gr3:\>100,000/mm\^3, Gr4:clinical manifestations of leucostasis;Gr5:Death. Abnormal Neutrophil count (ANC):- Gr1:\<LLN-1500/mm\^3;Gr2:\<1500-1000/mm\^3; Gr3: \<1000-500/mm\^3; Gr4:\<500/mm\^3. Platelet count decreased: Gr1:\<LLN-75,000/mm\^3;Gr2:\<75,000-50,000/mm\^3;Gr3:\<50,000-25,000/mm\^3;Gr4:\<25,000/mm\^3. |
| Secondary | Number of Participants With Shift of Laboratory Parameters (Sodium and Potassium Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | From Baseline up to 30 days after last dose of study drug (maximum duration: up to 10 years) | NCI-CTCAE version 4.03 was used to determine Gr,where Gr refers to severity of AE: Gr 1: mild; asymptomatic/mild symptoms; Gr 2: moderate; minimal; Gr 3:severe/medically significant; Gr 4:life-threatening consequences, Gr 5:death related to AE. Abnormal values for Sodium (Hyponatremia) were based on Gr1: \<LLN-130 mmol/L; Gr3: \<130-120 mmol/L; Gr4: \<120 mmol/L; life-threatening consequences; Gr5: death. Sodium (Hypernatremia):Gr 1: \>ULN-150 mmol/L; Gr2: \>150-155 mmol/L; Gr3:\>155-160 mmol/L;hospitalization; Gr4: \>160 mmol/L; life-threatening consequences; Gr5: Death. Potassium (Hypokalemia): Gr 1: \<LLN-3.0 mmol/L; Gr2: \<LLN-3.0 mmol/L; symptomatic; intervention indicated; Gr3: \<3.0-2.5 mmol/L; hospitalization indicated; Gr4: \<2.5 mmol/L; life-threatening consequences; Gr5: Death; Potassium(Hyperkalemia): Gr 1: \>ULN-5.5 mmol/L; Gr2: \>5.5-6.0 mmol/L; Gr3: \>6.0-7.0 mmol/L; hospitalization indicated; Gr4: \>7.0 mmol/L; life-threatening consequences; Gr5: Death. |
| Secondary | Number of Participants With Shift of Laboratory Parameters (Calcium, Creatinine and Albumin Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | From Baseline up to 30 days after last dose of study drug (maximum duration: up to 10 years) | NCI-CTCAE version 4.03 was used to determine Gr,where Gr refers to severity of AE:Gr 1:mild; asymptomatic/mild symptoms; Gr 2:moderate;minimal; Gr 3:severe/medically significant; Gr 4:life-threatening consequences, Gr 5:death related to AE. Abnormal values for Calcium(Hypocalcemia) were based on Gr1: Corrected serum calcium of \<LLN-8.0 mg/dL; Gr2: Corrected serum calcium of \<8.0-7.0 mg/dL; Gr3: Corrected serum calcium of \<7.0-6.0 mg/dL ; Gr4: Corrected serum calcium of \<6.0 mg/dL;Gr5:death. Calcium(Hypercalcemia):Gr 1: Corrected serum calcium of \>ULN -11.5 mg/dL; Gr2: Corrected serum calcium of \>11.5-12.5 mg/dL; Gr3: Corrected serum calcium of \>12.5-13.5 mg/dL; Gr4: Corrected serum calcium of \>13.5 mg/dL;Gr5:Death. Creatinine increased: Gr 1: \>1-1.5\*baseline; \>ULN-1.5\*ULN; Gr2: \>1.5-3.0\*baseline; \>1.5-3.0\*ULN; Gr3: \>3.0 baseline; \>3.0-6.0\*ULN; Gr4: \>6.0 x ULN. Albumin(Hypoalbuminemia): Gr 1: \<LLN-3 g/dL; Gr2: \<3-2 g/dL; Gr3: \<2 g/dL; Gr4:life-threatening consequences;Gr5:Death. |
| Secondary | Number of Participants With Shift of Laboratory Parameters (Aspartate Aminotransferase, Alanine Aminotransferase,Blood Bilirubin,Alkaline Phosphatase and Glucose Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | From Baseline up to 30 days after last dose of study drug (maximum duration: up to 10 years) | NCI-CTCAE version 4.03 was used to determine Gr, where Gr refers to severity of AE: Gr 1:mild; asymptomatic/mild symptoms; Gr 2:moderate; minimal; Gr 3:severe/medically significant; Gr 4:life-threatening consequences, Gr 5:death related to AE. Abnormal values for Aspartate and alanine aminotransferase increased were based on Gr1: \>ULN-3.0\*ULN; Gr2: \>3.0-5.0\*ULN; Gr3: \>5.0-20.0\*ULN; Gr4: \>20.0\*ULN. Blood bilirubin increased: Gr1: \>ULN-1.5\*ULN; Gr2 \>1.5-3.0\*ULN; Gr3: \>3.0-10.0\*ULN; Gr4: \>10.0\*ULN. Alkaline phosphatase increased: Gr1: \>ULN-2.5\*ULN; Gr2: \>2.5-5.0\*ULN; Gr3: \>5.0-20.0\*ULN; Gr4: \>20.0\*ULN. Glucose (Hypoglycemia): Gr 1: \<LLN-55 mg/dL; Gr2: \<55-40 mg/dL;Gr3: \<40-30 mg/dL; Gr4: \<30 mg/dL; Gr5:Death. Glucose (Hyperglycemia): Gr 1: Fasting glucose value \>ULN-160 mg/dL; Gr2: Fasting glucose value \>160-250 mg/dL; Gr3: \>250-500 mg/dL; Gr4: \>500 mg/dL; Gr5: Death. |
| Secondary | Number of Participants With Shift of Laboratory Parameters (Creatinine Clearance [Chronic Kidney Disease]) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | From Baseline up to 30 days after last dose of study drug (maximum duration: up to 10 years) | NCI-CTCAE version 4.03 was used to determine Gr, where Gr refers to severity of AE: Gr 1: mild; asymptomatic/mild symptoms; Gr 2: moderate; minimal; Gr 3: severe/medically significant; Gr 4:life-threatening consequences, Gr 5:death related to AE. Abnormal values for Creatinine Clearance(Chronic kidney disease) were based on: Gr 1: estimated glomerular filtration rate (eGFR) or creatinine clearance (CrCl) \<LLN-60ml/min/1.73 m\^2; Gr2: eGFR or CrCl 59-30 ml/min/1.73 m\^2; Gr3: eGFR or CrCl 29-15 ml/min/1.73 m\^2; Gr4: eGFR or CrCl \<15 ml/min/1.73 m\^2; Gr5: Death. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With 3-Year Progression-Free Survival (PFS), as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST)1.1 | 3 years | Full Analysis Set (FAS): included all randomized participants who satisfied inclusion/exclusion criteria and had at least one tumor assessment after baseline visit (Day 0). The CSC Arm included all participants exposed to at least one dose of Docetaxel+Oxaliplatin+S-1 investigational products. The SC Arm included all participants who had surgery. | percentage of participants | NUMBER |
| SECONDARY | Overall Survival (OS) | From randomization to date of death due to any cause (maximum duration: up to 10 years) | Analysis was performed on FAS population. | months | MEDIAN |
| SECONDARY | Number of Participants With Post-Operative Pathological Stage Response | Up to 10 years | Analysis was performed on FAS population. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Participants With R0 Resection | Up to 10 years | Analysis was performed on FAS population. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure. | percentage of participants | NUMBER |
| SECONDARY | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | From randomization up to 30 days after last dose of study drug (maximum duration: up to 10 years) | Analysis was performed on safety population which included participants who were administered at least one dose of the investigational product. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade to Worst National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Grade >=3 | From Baseline up to 30 days after last dose of study drug (maximum duration: up to 10 years) | Analysis was performed on safety population. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Shift of Laboratory Parameters (Sodium and Potassium Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | From Baseline up to 30 days after last dose of study drug (maximum duration: up to 10 years) | Analysis was performed on safety population. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Shift of Laboratory Parameters (Calcium, Creatinine and Albumin Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | From Baseline up to 30 days after last dose of study drug (maximum duration: up to 10 years) | Analysis was performed on safety population. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Shift of Laboratory Parameters (Aspartate Aminotransferase, Alanine Aminotransferase,Blood Bilirubin,Alkaline Phosphatase and Glucose Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | From Baseline up to 30 days after last dose of study drug (maximum duration: up to 10 years) | Analysis was performed on safety population. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Shift of Laboratory Parameters (Creatinine Clearance [Chronic Kidney Disease]) From Baseline Grade to Worst NCI-CTCAE Grade >=3 | From Baseline up to 30 days after last dose of study drug (maximum duration: up to 10 years) | Analysis was performed on safety population. Data was planned to be collected and analyzed for Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) arm only. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group276
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With 3-Year Progression-Free Survival (PFS), as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST)1.1 | Surgery + Adjuvant Chemotherapy (SC) | 60.24 | 95% Confidence Interval 53.55 to 66.28 | percentage of participants | |
| Percentage of Participants With 3-Year Progression-Free Survival (PFS), as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST)1.1 | Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) | 66.82 | 95% Confidence Interval 60.13 to 72.65 | percentage of participants | |
| Overall Survival (OS) | Surgery + Adjuvant Chemotherapy (SC) | NA | 95% Confidence Interval NA to NA | months | |
| Overall Survival (OS) | Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) | NA | 95% Confidence Interval NA to NA | months | |
| Number of Participants With Post-Operative Pathological Stage Response | Surgery + Adjuvant Chemotherapy (SC) | Stage 0 | 0 | Participants | |
| Number of Participants With Post-Operative Pathological Stage Response | Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) | Stage 0 | 23 | Participants | |
| Number of Participants With Post-Operative Pathological Stage Response | Surgery + Adjuvant Chemotherapy (SC) | Stage IA | 9 | Participants | |
| Number of Participants With Post-Operative Pathological Stage Response | Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) | Stage IA | 32 | Participants | |
| Number of Participants With Post-Operative Pathological Stage Response | Surgery + Adjuvant Chemotherapy (SC) | Stage IB | 18 | Participants | |
| Number of Participants With Post-Operative Pathological Stage Response | Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) | Stage IB | 23 | Participants |
1 to 10 of 276Source ClinicalTrials.gov
See all 276 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Surgery + Adjuvant Chemotherapy (SC) | 264 | |
| Overall Study | STARTED | Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) | 266 | |
| Overall Study | Treated | Surgery + Adjuvant Chemotherapy (SC) | 195 | |
| Overall Study | Treated | Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) | 241 | |
| Overall Study | COMPLETED | Surgery + Adjuvant Chemotherapy (SC) | 225 | |
| Overall Study | COMPLETED | Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) | 211 | |
| Overall Study | NOT COMPLETED | Surgery + Adjuvant Chemotherapy (SC) | 39 | |
| Overall Study | NOT COMPLETED | Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) | 55 |
Source ClinicalTrials.gov
Adverse events238
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Surgery + Adjuvant Chemotherapy (SC) | 19 | 195 | 20 |
| other | Anaemia | Blood and lymphatic system disorders | Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) | 18 | 241 | 21 |
| other | Dry Eye | Eye disorders | Surgery + Adjuvant Chemotherapy (SC) | 11 | 195 | 11 |
| other | Dry Eye | Eye disorders | Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) | 8 | 241 | 10 |
| other | Lacrimation Increased | Eye disorders | Surgery + Adjuvant Chemotherapy (SC) | 23 | 195 | 27 |
| other | Lacrimation Increased | Eye disorders | Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) | 22 | 241 | 25 |
| other | Abdominal Pain Upper | Gastrointestinal disorders | Surgery + Adjuvant Chemotherapy (SC) | 7 | 195 | 7 |
| other | Abdominal Pain Upper | Gastrointestinal disorders | Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) | 14 | 241 | 16 |
| other | Dyspepsia | Gastrointestinal disorders | Surgery + Adjuvant Chemotherapy (SC) | 43 | 195 | 65 |
| other | Dyspepsia | Gastrointestinal disorders | Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) | 65 | 241 | 90 |
1 to 10 of 238Source ClinicalTrials.gov
See all 238 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Surgery + Adjuvant Chemotherapy (SC) | 91 | 264 |
| Total, all-cause mortality | Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) | 78 | 266 |
| Total, other adverse events | Surgery + Adjuvant Chemotherapy (SC) | 141 | 195 |
| Total, other adverse events | Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) | 201 | 241 |
| Total, serious adverse events | Surgery + Adjuvant Chemotherapy (SC) | 57 | 195 |
| Total, serious adverse events | Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) | 102 | 241 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Surgery + Adjuvant Chemotherapy (SC) vs Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC): deaths from any cause | Trial comparisons |
| Surgery + Adjuvant Chemotherapy (SC) vs Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC): serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01515748
GET https://conductscience.org/api/trials/v1/NCT01515748/results?page=2