Trial · NCT00590031
Phase II Trial of Preoperative Combined Modality Therapy for Esophageal Carcinoma: Cisplatin-Irinotecan Followed by Radiation Therapy With Concurrent Cisplatin and Irinotecan.
NCT00590031, Phase 2, Completed, Memorial Sloan Kettering Cancer Center; results first posted 2016-01-25
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Phase II Trial of Preoperative Combined Modality Therapy for Esophageal Carcinoma: Cisplatin-Irinotecan Followed by Radiation Therapy With Concurrent Cisplatin and Irinotecan. Trials, record NCT00590031. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00590031
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase II Trial of Preoperative Combined Modality Therapy for Esophageal Carcinoma: Cisplatin-Irinotecan Followed by Radiation Therapy With Concurrent Cisplatin and Irinotecan.
- NCT number
- NCT00590031
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 61 participants, actual
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Conditions
- Esophageal Carcinoma
- Interventions
- Cisplatin, Irinotecan, External Beam Radiation Therapy
- First posted
- 2008-01-10
- Last updated
- 2016-01-25
- Results first posted
- 2016-01-25
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Pathologic Complete Response | 2 years | Pathological information will be available for all patients who receive surgery. If a patient is deemed unresectable based on clinical and radiological examination after the therapy, that patient will be counted as non-responder. The best overall response is the best response recorded from the start of treatment until disease progression (taking as reference for progressive disease the smallest measurements recorded since the treatment started). The subject's best response assignment will depend on the achievement of both measurement and confirmation criteria. We will also estimate the pathological complete response rates separately for each of these tumor types. Survival and disease-free survival will be estimated using Kaplan-Meier method. With an accrual rate of 3 patients a month, we expect the study to be completed in 18 months. |
| Secondary | Evaluate Toxicity and Tolerability Including Surgical Morbidity and Mortality | 2 years |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Pathologic Complete Response | 2 years | participants | NUMBER | |
| SECONDARY | Evaluate Toxicity and Tolerability Including Surgical Morbidity and Mortality | 2 years | participants | NUMBER |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Pathologic Complete Response | Combined Modality Therapy for Esophageal Carcinoma | 55 | participants | ||
| Evaluate Toxicity and Tolerability Including Surgical Morbidity and Mortality | Combined Modality Therapy for Esophageal Carcinoma | 55 | 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 | Combined Modality Therapy for Esophageal Carcinoma | 61 | |
| Overall Study | COMPLETED | Combined Modality Therapy for Esophageal Carcinoma | 55 | |
| Overall Study | NOT COMPLETED | Combined Modality Therapy for Esophageal Carcinoma | 6 |
Source ClinicalTrials.gov
Adverse events51
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 | Alkaline phosphatase | Investigations | Combined Modality Therapy for Esophageal Carcinoma | 3 | 55 | 3 |
| other | Alopecia | Skin and subcutaneous tissue disorders | Combined Modality Therapy for Esophageal Carcinoma | 4 | 55 | 5 |
| other | Anorexia | Metabolism and nutrition disorders | Combined Modality Therapy for Esophageal Carcinoma | 5 | 55 | 5 |
| other | Bilirubin | Investigations | Combined Modality Therapy for Esophageal Carcinoma | 11 | 55 | 50 |
| other | Dyspnea | Respiratory, thoracic and mediastinal disorders | Combined Modality Therapy for Esophageal Carcinoma | 8 | 55 | 10 |
| other | Creatinine | Investigations | Combined Modality Therapy for Esophageal Carcinoma | 5 | 55 | 30 |
| other | Diarrhea (Pts w/out col) | Gastrointestinal disorders | Combined Modality Therapy for Esophageal Carcinoma | 5 | 55 | 5 |
| other | Dysphagia, esophagitis | Gastrointestinal disorders | Combined Modality Therapy for Esophageal Carcinoma | 7 | 55 | 7 |
| other | Dysphagia-esophageal | Gastrointestinal disorders | Combined Modality Therapy for Esophageal Carcinoma | 5 | 55 | 5 |
| other | Fatigue | General disorders | Combined Modality Therapy for Esophageal Carcinoma | 20 | 55 | 20 |
1 to 10 of 51Source ClinicalTrials.gov
See all 51 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Combined Modality Therapy for Esophageal Carcinoma | ||
| Total, other adverse events | Combined Modality Therapy for Esophageal Carcinoma | 55 | 55 |
| Total, serious adverse events | Combined Modality Therapy for Esophageal Carcinoma | 22 | 55 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT00590031
GET https://conductscience.org/api/trials/v1/NCT00590031/events?page=2