Trial · NCT04097028
Use of Trifluridine/Tipiracil and Oxaliplatin as Induction Chemotherapy for the Treatment of Resectable Esophageal or Gastroesophageal Junction (GEJ) Adenocarcinoma
NCT04097028, Phase 2, Completed, Roswell Park Cancer Institute; results first posted 2024-01-18
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Use of Trifluridine/Tipiracil and Oxaliplatin as Induction Chemotherapy for the Treatment of Resectable Esophageal or Gastroesophageal Junction (GEJ) Adenocarcinoma. Trials, record NCT04097028. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04097028
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Use of Trifluridine/Tipiracil and Oxaliplatin as Induction Chemotherapy for the Treatment of Resectable Esophageal or Gastroesophageal Junction (GEJ) Adenocarcinoma
- NCT number
- NCT04097028
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 22 participants, actual
- Lead sponsor
- Roswell Park Cancer Institute
- Conditions
Clinical Stage IIA Esophageal Adenocarcinoma AJCC v8, Clinical Stage IIA Gastroesophageal Junction Adenocarcinoma AJCC v8, Clinical Stage III Esophageal Adenocarcinoma AJCC v8, Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8, Clinical Stage IVA Esophageal Adenocarcinoma AJCC v8, Clinical Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8, Pathologic Stage IIB Esophageal Adenocarcinoma AJCC v8, Pathologic Stage IIB Gastroesophageal Junction Adenocarcinoma AJCC v8, Pathologic Stage III Esophageal Adenocarcinoma AJCC v8, Pathologic Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8, Pathologic Stage IIIA Esophageal Adenocarcinoma AJCC v8, Pathologic Stage IIIA Gastroesophageal Junction Adenocarcinoma AJCC v8, Pathologic Stage IIIB Esophageal Adenocarcinoma AJCC v8, Pathologic Stage IIIB Gastroesophageal Junction Adenocarcinoma AJCC v8, Pathologic Stage IVA Esophageal Adenocarcinoma AJCC v8, Pathologic Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8
- Interventions
- Trifluridine and Tipiracil Hydrochloride, Oxaliplatin
- First posted
- 2019-09-20
- Last updated
- 2025-04-29
- Results first posted
- 2024-01-18
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Patients With a Pathologic Complete Response | Assessed at the time of surgery (approximately 6 months after start of neoadjuvant therapy) | Will be determined by pathologic examination of resected specimen: complete response to induction chemotherapy followed by standard chemoradiation and surgery. Will be summarized using frequencies and relative frequencies. Will be estimated using an 80% confidence interval obtained using Jeffrey's prior method. Response is assessed by the tumor regression score (as proposed by NCCN guidelines): Complete Response: No viable cancer cells, including lymph nodes Near Complete Response: Single cells or rare small groups of cancer cells Partial Response: Residual cancer with evident tumor regression but more than single cells or rare small groups of cancer cells Poor or No Response: Extensive residual disease with no evident tumor regression |
| Secondary | Median Progression Free Survival | Time from treatment until disease progression, death from disease, or last follow-up, assessed up to 2 years | Will be summarized using standard Kaplan-Meier methods; where estimates of median survival and two-year survival rates will be obtained with 95% confidence intervals. Progression is assessed by RECIST v1.0, defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. |
| Secondary | Median Overall Survival | Time from treatment until death due to any cause or last follow-up, assessed up to 2 years | Will be summarized using standard Kaplan-Meier methods; where estimates of median survival and two-year survival rates will be obtained with 95% confidence intervals |
| Secondary | Number of Patients With Grade 3 or Higher Treatment Related Adverse Events | Up to 30 days after last dose of study drug, which is a maximum of 210 days. | Toxicities and adverse events (as per Common Terminology Criteria for Adverse Events version 5.0) will be summarized by attribution and grade using frequencies and relative frequencies. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Patients With a Pathologic Complete Response | Assessed at the time of surgery (approximately 6 months after start of neoadjuvant therapy) | Only 15 patients completed surgery. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Median Progression Free Survival | Time from treatment until disease progression, death from disease, or last follow-up, assessed up to 2 years | months | MEDIAN | |
| SECONDARY | Median Overall Survival | Time from treatment until death due to any cause or last follow-up, assessed up to 2 years | months | MEDIAN | |
| SECONDARY | Number of Patients With Grade 3 or Higher Treatment Related Adverse Events | Up to 30 days after last dose of study drug, which is a maximum of 210 days. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Patients With a Pathologic Complete Response | Treatment (TAS-102, Oxaliplatin) | 2 | Participants | ||
| Median Progression Free Survival | Treatment (TAS-102, Oxaliplatin) | 20.3 | 95% Confidence Interval 5.9 to NA | months | |
| Median Overall Survival | Treatment (TAS-102, Oxaliplatin) | 20.3 | 95% Confidence Interval 8.6 to NA | months | |
| Number of Patients With Grade 3 or Higher Treatment Related Adverse Events | Treatment (TAS-102, Oxaliplatin) | 5 | Participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Treatment (TAS-102, Oxaliplatin) | 22 | |
| Overall Study | COMPLETED | Treatment (TAS-102, Oxaliplatin) | 15 | |
| Overall Study | NOT COMPLETED | Treatment (TAS-102, Oxaliplatin) | 7 |
Source ClinicalTrials.gov
Adverse events30
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 | Anemia | Blood and lymphatic system disorders | Treatment (TAS-102, Oxaliplatin) | 2 | 22 | 2 |
| other | Sinus tachycardia | Cardiac disorders | Treatment (TAS-102, Oxaliplatin) | 3 | 22 | 3 |
| other | Abdominal pain | Gastrointestinal disorders | Treatment (TAS-102, Oxaliplatin) | 3 | 22 | 3 |
| other | Bloating | Gastrointestinal disorders | Treatment (TAS-102, Oxaliplatin) | 2 | 22 | 2 |
| other | Constipation | Gastrointestinal disorders | Treatment (TAS-102, Oxaliplatin) | 11 | 22 | 11 |
| other | Diarrhea | Gastrointestinal disorders | Treatment (TAS-102, Oxaliplatin) | 9 | 22 | 9 |
| other | Dyspepsia | Gastrointestinal disorders | Treatment (TAS-102, Oxaliplatin) | 2 | 22 | 2 |
| other | Flatulence | Gastrointestinal disorders | Treatment (TAS-102, Oxaliplatin) | 2 | 22 | 2 |
| other | Mucositis oral | Gastrointestinal disorders | Treatment (TAS-102, Oxaliplatin) | 3 | 22 | 3 |
| other | Nausea | Gastrointestinal disorders | Treatment (TAS-102, Oxaliplatin) | 13 | 22 | 13 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment (TAS-102, Oxaliplatin) | 7 | 22 |
| Total, other adverse events | Treatment (TAS-102, Oxaliplatin) | 17 | 22 |
| Total, serious adverse events | Treatment (TAS-102, Oxaliplatin) | 3 | 22 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 40200573 | DERIVED |
Source PubMed
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT04097028
GET https://conductscience.org/api/trials/v1/NCT04097028/events?page=2