TriangleNCT01196390 · STUDY IN CONTEXT
Radiation Therapy, Paclitaxel, and Carboplatin With or Without Trastuzumab in Treating Patients With Esophageal Cancer
Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
Read the full study record and all posted results →
Linked outcomes
A disease event is defined as local/regional persistence or recurrence of the cancer under study, distant metastases, a new second primary cancer, or death due to any cause. Participants undergoing surgery who had an R2 resection and participants not undergoing surgery who had a positive endoscopic biopsy or no biopsy at all were considered to have local persistence of disease. Disease-free survival time is defined as time from randomization to the date of first disease event or last known follow-up (censored). Rates are estimated by the Kaplan-Meier method. Analysis was to occur after 162 events were reported.
Pathologic Complete Response (pCR) is evaluated after surgery and is based on the pathology review of the submitted surgical specimen. Pathologic Complete Response occurs if the pathologist determines that the resected esophageal specimen, accompanying lymph nodes, and surgical margins are all free of tumor.
Overall survival time is defined as time from randomization to the date of death from any cause or last known follow-up (censored). Rates are estimated by the Kaplan-Meier method. Analysis occurred after 109 deaths were reported.
Common Terminology Criteria for Adverse Events (version 4.0 before 4-1-2018; then version 5.0) grades adverse event severity from 1=mild to 5=death. Summary data provided is in this outcome measure; see Adverse Events Module for specific adverse event data.
The ECS is a 17-item self-report instrument designed to measure multidimensional quality of life in patients with esophagus cancer with a total score ranging from 0-68. It is to be administered with the Functional Assessment of Cancer Therapy - General (FACT-G). A higher score indicates better QOL. Improvement is defined as an increase from the baseline score of at least 5 points.
Quality-adjusted Survival
Reported safety
Quality of life and patient-reported measures
FACT · Percentage of Patients With Improvement in the Functional Assessment of Cancer Therapy - Esophagus (FACT-E) Esophageal Cancer Subscale (ECS) Subscale After Treatment
Score direction: Higher is better, according to the source. Direction is never inferred from an instrument name.
- release id
- clinical-indications-draft-1
- disease state id
- ds-gastroesophageal-junction-carcinoma
- nct id
- NCT01196390
- qol key
- qol-0004
- source section id
- NCT01196390-om-0004
- source outcome index
- 4
- instrument
- FACT
- instrument basis
- matched 'fact-e' in the study's own wording
- scale title
- Percentage of Patients With Improvement in the Functional Assessment of Cancer Therapy - Esophagus (FACT-E) Esophageal Cancer Subscale (ECS) Subscale After Treatment
- measure definition
- The ECS is a 17-item self-report instrument designed to measure multidimensional quality of life in patients with esophagus cancer with a total score ranging from 0-68. It is to be administered with the Functional Assessment of Cancer Therapy - General (FACT-G). A higher score indicates better QOL. Improvement is defined as an increase from the baseline score of at least 5 points.
- time frame
- Baseline, 6-8 weeks after end of radiation therapy (approximately 11.5-13.5 weeks from treatment start), 1 and 2 years from treatment start
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- 1
- direction quote
- higher score indicates better
- population note
- Eligible participants who consented to quality of life evaluation and who had baseline and time point data.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
Full draft applicability and source-link record
- trial
- release id
- clinical-indications-draft-1
- disease state id
- ds-gastroesophageal-junction-carcinoma
- nct id
- NCT01196390
- trial label
- Radiation Therapy, Paclitaxel, and Carboplatin With or Without Trastuzumab in Treating Patients With Esophageal Cancer
- applicability
- narrower
- applicability note
- Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- provenance class
- regulator-cited
- discovery note
- Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
- outcome Count
- 6
- harms Count
- 2
- qol Count
- 1
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-gastroesophageal-junction-carcinoma
- nct id
- NCT01196390
- outcome key
- om-0000
- source section id
- NCT01196390-om-0000
- source outcome index
- 0
- endpoint
- Disease-free Survival (DFS)
- endpoint definition
- A disease event is defined as local/regional persistence or recurrence of the cancer under study, distant metastases, a new second primary cancer, or death due to any cause. Participants undergoing surgery who had an R2 resection and participants not undergoing surgery who had a positive endoscopic biopsy or no biopsy at all were considered to have local persistence of disease. Disease-free survival time is defined as time from randomization to the date of first disease event or last known follow-up (censored). Rates are estimated by the Kaplan-Meier method. Analysis was to occur after 162 events were reported.
- time origin
- From randomization to last follow-up. Maximum follow-up at time of analysis was 8.0 years.
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Eligible randomized participants
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-gastroesophageal-junction-carcinoma
- nct id
- NCT01196390
- outcome key
- om-0001
- source section id
- NCT01196390-om-0001
- source outcome index
- 1
- endpoint
- Percentage of Participants With Pathologic Complete Response at Surgery
- endpoint definition
- Pathologic Complete Response (pCR) is evaluated after surgery and is based on the pathology review of the submitted surgical specimen. Pathologic Complete Response occurs if the pathologist determines that the resected esophageal specimen, accompanying lymph nodes, and surgical margins are all free of tumor.
- time origin
- At the time of surgery, 5-8 weeks after completion of radiation therapy.
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Eligible participants who had surgery
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-gastroesophageal-junction-carcinoma
- nct id
- NCT01196390
- outcome key
- om-0002
- source section id
- NCT01196390-om-0002
- source outcome index
- 2
- endpoint
- Overall Survival
- endpoint definition
- Overall survival time is defined as time from randomization to the date of death from any cause or last known follow-up (censored). Rates are estimated by the Kaplan-Meier method. Analysis occurred after 109 deaths were reported.
- time origin
- From randomization to last follow-up. Maximum follow-up at time of analysis was 8 years.
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Eligible randomized participants
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-gastroesophageal-junction-carcinoma
- nct id
- NCT01196390
- outcome key
- om-0003
- source section id
- NCT01196390-om-0003
- source outcome index
- 3
- endpoint
- Frequency of Highest Grade Adverse Event Per Participant
- endpoint definition
- Common Terminology Criteria for Adverse Events (version 4.0 before 4-1-2018; then version 5.0) grades adverse event severity from 1=mild to 5=death. Summary data provided is in this outcome measure; see Adverse Events Module for specific adverse event data.
- time origin
- From randomization to last follow-up. Maximum follow-up at time of analysis was 8 years.
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Eligible participants who started study treatment
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-gastroesophageal-junction-carcinoma
- nct id
- NCT01196390
- outcome key
- om-0004
- source section id
- NCT01196390-om-0004
- source outcome index
- 4
- endpoint
- Percentage of Patients With Improvement in the Functional Assessment of Cancer Therapy - Esophagus (FACT-E) Esophageal Cancer Subscale (ECS) Subscale After Treatment
- endpoint definition
- The ECS is a 17-item self-report instrument designed to measure multidimensional quality of life in patients with esophagus cancer with a total score ranging from 0-68. It is to be administered with the Functional Assessment of Cancer Therapy - General (FACT-G). A higher score indicates better QOL. Improvement is defined as an increase from the baseline score of at least 5 points.
- time origin
- Baseline, 6-8 weeks after end of radiation therapy (approximately 11.5-13.5 weeks from treatment start), 1 and 2 years from treatment start
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Eligible participants who consented to quality of life evaluation and who had baseline and time point data.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-gastroesophageal-junction-carcinoma
- nct id
- NCT01196390
- outcome key
- om-0005
- source section id
- NCT01196390-om-0005
- source outcome index
- 5
- endpoint
- Quality-adjusted Survival
- endpoint definition
- Quality-adjusted Survival
- time origin
- From randomization to last follow-up. Maximum follow-up at time of primary outcome measure analysis was 8 years.
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- The protocol states that this outcome measure will be analyzed only if primary outcome results are positive, i.e. support the primary hypothesis of this study. Therefore no participants were analyzed for this outcome measure.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- arms
- release id
- clinical-indications-draft-1
- disease state id
- ds-gastroesophageal-junction-carcinoma
- nct id
- NCT01196390
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Chemoradiation and Trastuzumab (Arm 1)
- regimen
- Radiation therapy with concurrent trastuzumab, paclitaxel, and carboplatin followed by surgery followed by maintenance trastuzumab
- analyzed count
- 98
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01196390-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-gastroesophageal-junction-carcinoma
- nct id
- NCT01196390
- outcome key
- om-0000
- arm key
- OG001
- arm label
- Chemoradiation (Arm 2)
- regimen
- Radiation therapy with concurrent paclitaxel and carboplatin followed by surgery
- analyzed count
- 96
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01196390-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-gastroesophageal-junction-carcinoma
- nct id
- NCT01196390
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Chemoradiation and Trastuzumab
- regimen
- Radiation therapy with concurrent trastuzumab, paclitaxel, and carboplatin followed by surgery followed by maintenance trastuzumab
- analyzed count
- 82
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01196390-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-gastroesophageal-junction-carcinoma
- nct id
- NCT01196390
- outcome key
- om-0001
- arm key
- OG001
- arm label
- Chemoradiation
- regimen
- Radiation therapy with concurrent paclitaxel and carboplatin followed by surgery
- analyzed count
- 78
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01196390-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-gastroesophageal-junction-carcinoma
- nct id
- NCT01196390
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Chemoradiation and Trastuzumab
- regimen
- Radiation therapy with concurrent trastuzumab, paclitaxel, and carboplatin followed by surgery followed by maintenance trastuzumab
- analyzed count
- 98
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01196390-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-gastroesophageal-junction-carcinoma
- nct id
- NCT01196390
- outcome key
- om-0002
- arm key
- OG001
- arm label
- Chemoradiation
- regimen
- Radiation therapy with concurrent paclitaxel and carboplatin followed by surgery
- analyzed count
- 96
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01196390-om-0002#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-gastroesophageal-junction-carcinoma
- nct id
- NCT01196390
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Chemoradiation and Trastuzumab
- regimen
- Radiation therapy with concurrent trastuzumab, paclitaxel, and carboplatin followed by surgery followed by maintenance trastuzumab
- analyzed count
- 95
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01196390-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-gastroesophageal-junction-carcinoma
- nct id
- NCT01196390
- outcome key
- om-0003
- arm key
- OG001
- arm label
- Chemoradiation
- regimen
- Radiation therapy with concurrent paclitaxel and carboplatin followed by surgery
- analyzed count
- 96
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01196390-om-0003#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-gastroesophageal-junction-carcinoma
- nct id
- NCT01196390
- outcome key
- om-0004
- arm key
- OG000
- arm label
- Chemoradiation and Trastuzumab
- regimen
- Radiation therapy with concurrent trastuzumab, paclitaxel, and carboplatin followed by surgery followed by maintenance trastuzumab
- analyzed count
- 88
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01196390-om-0004#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-gastroesophageal-junction-carcinoma
- nct id
- NCT01196390
- outcome key
- om-0004
- arm key
- OG001
- arm label
- Chemoradiation
- regimen
- Radiation therapy with concurrent paclitaxel and carboplatin followed by surgery
- analyzed count
- 83
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01196390-om-0004#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-gastroesophageal-junction-carcinoma
- nct id
- NCT01196390
- outcome key
- om-0005
- arm key
- OG000
- arm label
- Chemoradiation and Trastuzumab
- regimen
- Radiation therapy with concurrent trastuzumab, paclitaxel, and carboplatin followed by surgery followed by maintenance trastuzumab
- analyzed count
- 0
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01196390-om-0005#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-gastroesophageal-junction-carcinoma
- nct id
- NCT01196390
- outcome key
- om-0005
- arm key
- OG001
- arm label
- Chemoradiation
- regimen
- Radiation therapy with concurrent paclitaxel and carboplatin followed by surgery
- analyzed count
- 0
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01196390-om-0005#groups/OG001
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-gastroesophageal-junction-carcinoma
- nct id
- NCT01196390
- harm key
- EG000
- source section id
- NCT01196390-ae
- event group key
- EG000
- event group label
- Chemoradiation and Trastuzumab
- serious affected
- 51
- serious at risk
- 95
- other affected
- 95
- other at risk
- 95
- frequency threshold
- 5
- collection period
- Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
- event definition
- Source null
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-gastroesophageal-junction-carcinoma
- nct id
- NCT01196390
- harm key
- EG001
- source section id
- NCT01196390-ae
- event group key
- EG001
- event group label
- Chemoradiation
- serious affected
- 34
- serious at risk
- 96
- other affected
- 96
- other at risk
- 96
- frequency threshold
- 5
- collection period
- Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
- event definition
- Source null
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- quality of life
- release id
- clinical-indications-draft-1
- disease state id
- ds-gastroesophageal-junction-carcinoma
- nct id
- NCT01196390
- qol key
- qol-0004
- source section id
- NCT01196390-om-0004
- source outcome index
- 4
- instrument
- FACT
- instrument basis
- matched 'fact-e' in the study's own wording
- scale title
- Percentage of Patients With Improvement in the Functional Assessment of Cancer Therapy - Esophagus (FACT-E) Esophageal Cancer Subscale (ECS) Subscale After Treatment
- measure definition
- The ECS is a 17-item self-report instrument designed to measure multidimensional quality of life in patients with esophagus cancer with a total score ranging from 0-68. It is to be administered with the Functional Assessment of Cancer Therapy - General (FACT-G). A higher score indicates better QOL. Improvement is defined as an increase from the baseline score of at least 5 points.
- time frame
- Baseline, 6-8 weeks after end of radiation therapy (approximately 11.5-13.5 weeks from treatment start), 1 and 2 years from treatment start
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- 1
- direction quote
- higher score indicates better
- population note
- Eligible participants who consented to quality of life evaluation and who had baseline and time point data.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- setting source links
Preserved source evidence · Not medical advice