TriangleNCT00903396 · STUDY IN CONTEXT
Palonosetron Hydrochloride in Preventing Nausea and Vomiting Caused by Radiation Therapy in Patients With Primary Abdominal 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 by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
Read the full study record and all posted results →
Linked outcomes
Complete Response (no Episodes of Nausea or Vomiting)
Time to Treatment Failure, Defined as a Single Episode of Vomiting, Daily Nausea Score of Moderate or Greater, or Taking ≥ 3 Prochlorperazine or Haloperidol Tablets Per Day
Proportion of Patients Reporting Treatment Failure
Tolerability and Adverse Events as Assessed by NCI CTC v 3.0
Average Level of Nausea Reported and the Proportion of Patients Experiencing a Complete Response Independent of Treatment Arm
Reported safety
Quality of life and patient-reported measures
No linked quality-of-life measure is recorded for this setting and study.
Full draft applicability and source-link record
- trial
- release id
- clinical-indications-draft-1
- disease state id
- ds-colorectal-neoplasm
- nct id
- NCT00903396
- trial label
- Palonosetron Hydrochloride in Preventing Nausea and Vomiting Caused by Radiation Therapy in Patients With Primary Abdominal 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
- registry-condition-search
- discovery note
- Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
- outcome Count
- 5
- harms Count
- 4
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-colorectal-neoplasm
- nct id
- NCT00903396
- outcome key
- om-0000
- source section id
- NCT00903396-om-0000
- source outcome index
- 0
- endpoint
- Complete Response (no Episodes of Nausea or Vomiting)
- endpoint definition
- Complete Response (no Episodes of Nausea or Vomiting)
- time origin
- Up to 2 years
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Not enough patients were accrued. In order to avoid identification of patients, no results will be entered.
- 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-colorectal-neoplasm
- nct id
- NCT00903396
- outcome key
- om-0001
- source section id
- NCT00903396-om-0001
- source outcome index
- 1
- endpoint
- Time to Treatment Failure, Defined as a Single Episode of Vomiting, Daily Nausea Score of Moderate or Greater, or Taking ≥ 3 Prochlorperazine or Haloperidol Tablets Per Day
- endpoint definition
- Time to Treatment Failure, Defined as a Single Episode of Vomiting, Daily Nausea Score of Moderate or Greater, or Taking ≥ 3 Prochlorperazine or Haloperidol Tablets Per Day
- time origin
- Up to 2 years
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Not enough patients were accrued. In order to avoid identification of patients, no results will be entered.
- 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-colorectal-neoplasm
- nct id
- NCT00903396
- outcome key
- om-0002
- source section id
- NCT00903396-om-0002
- source outcome index
- 2
- endpoint
- Proportion of Patients Reporting Treatment Failure
- endpoint definition
- Proportion of Patients Reporting Treatment Failure
- time origin
- Up to 2 years
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Not enough patients were accrued. In order to avoid identification of patients, no results will be entered.
- 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-colorectal-neoplasm
- nct id
- NCT00903396
- outcome key
- om-0003
- source section id
- NCT00903396-om-0003
- source outcome index
- 3
- endpoint
- Tolerability and Adverse Events as Assessed by NCI CTC v 3.0
- endpoint definition
- Tolerability and Adverse Events as Assessed by NCI CTC v 3.0
- time origin
- Up to 2 years
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Not enough patients were accrued. In order to avoid identification of patients, no results will be entered.
- 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-colorectal-neoplasm
- nct id
- NCT00903396
- outcome key
- om-0004
- source section id
- NCT00903396-om-0004
- source outcome index
- 4
- endpoint
- Average Level of Nausea Reported and the Proportion of Patients Experiencing a Complete Response Independent of Treatment Arm
- endpoint definition
- Average Level of Nausea Reported and the Proportion of Patients Experiencing a Complete Response Independent of Treatment Arm
- time origin
- Up to 2 years
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Not enough patients were accrued. In order to avoid identification of patients, no results will be entered.
- 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-colorectal-neoplasm
- nct id
- NCT00903396
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Arm I
- regimen
- Patients receive palonosetron hydrochloride IV on day 1. palonosetron hydrochloride: Given IV
- analyzed count
- 0
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00903396-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-colorectal-neoplasm
- nct id
- NCT00903396
- outcome key
- om-0000
- arm key
- OG001
- arm label
- Arm II
- regimen
- Patients receive palonosetron hydrochloride IV on days 1 and 4. palonosetron hydrochloride: Given IV
- analyzed count
- 0
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00903396-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-colorectal-neoplasm
- nct id
- NCT00903396
- outcome key
- om-0000
- arm key
- OG002
- arm label
- Arm III
- regimen
- Patients receive placebo IV on day 1. placebo: Given IV
- analyzed count
- 0
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00903396-om-0000#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-colorectal-neoplasm
- nct id
- NCT00903396
- outcome key
- om-0000
- arm key
- OG003
- arm label
- Arm IV
- regimen
- Patients receive placebo IV on days 1 and 4. placebo: Given IV
- analyzed count
- 0
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00903396-om-0000#groups/OG003
- release id
- clinical-indications-draft-1
- disease state id
- ds-colorectal-neoplasm
- nct id
- NCT00903396
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Arm I
- regimen
- Patients receive palonosetron hydrochloride IV on day 1. palonosetron hydrochloride: Given IV
- analyzed count
- 0
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00903396-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-colorectal-neoplasm
- nct id
- NCT00903396
- outcome key
- om-0001
- arm key
- OG001
- arm label
- Arm II
- regimen
- Patients receive palonosetron hydrochloride IV on days 1 and 4. palonosetron hydrochloride: Given IV
- analyzed count
- 0
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00903396-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-colorectal-neoplasm
- nct id
- NCT00903396
- outcome key
- om-0001
- arm key
- OG002
- arm label
- Arm III
- regimen
- Patients receive placebo IV on day 1. placebo: Given IV
- analyzed count
- 0
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00903396-om-0001#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-colorectal-neoplasm
- nct id
- NCT00903396
- outcome key
- om-0001
- arm key
- OG003
- arm label
- Arm IV
- regimen
- Patients receive placebo IV on days 1 and 4. placebo: Given IV
- analyzed count
- 0
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00903396-om-0001#groups/OG003
- release id
- clinical-indications-draft-1
- disease state id
- ds-colorectal-neoplasm
- nct id
- NCT00903396
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Arm I
- regimen
- Patients receive palonosetron hydrochloride IV on day 1. palonosetron hydrochloride: Given IV
- analyzed count
- 0
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00903396-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-colorectal-neoplasm
- nct id
- NCT00903396
- outcome key
- om-0002
- arm key
- OG001
- arm label
- Arm II
- regimen
- Patients receive palonosetron hydrochloride IV on days 1 and 4. palonosetron hydrochloride: Given IV
- analyzed count
- 0
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00903396-om-0002#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-colorectal-neoplasm
- nct id
- NCT00903396
- outcome key
- om-0002
- arm key
- OG002
- arm label
- Arm III
- regimen
- Patients receive placebo IV on day 1. placebo: Given IV
- analyzed count
- 0
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00903396-om-0002#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-colorectal-neoplasm
- nct id
- NCT00903396
- outcome key
- om-0002
- arm key
- OG003
- arm label
- Arm IV
- regimen
- Patients receive placebo IV on days 1 and 4. placebo: Given IV
- analyzed count
- 0
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00903396-om-0002#groups/OG003
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-colorectal-neoplasm
- nct id
- NCT00903396
- harm key
- EG000
- source section id
- NCT00903396-ae
- event group key
- EG000
- event group label
- Arm I
- serious affected
- 0
- serious at risk
- 0
- other affected
- 0
- other at risk
- 0
- frequency threshold
- 0
- collection period
- Source null
- event definition
- Not enough patients were accrued. In order to avoid identification of patients, no results will be entered.
- 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-colorectal-neoplasm
- nct id
- NCT00903396
- harm key
- EG001
- source section id
- NCT00903396-ae
- event group key
- EG001
- event group label
- Arm II
- serious affected
- 0
- serious at risk
- 0
- other affected
- 0
- other at risk
- 0
- frequency threshold
- 0
- collection period
- Source null
- event definition
- Not enough patients were accrued. In order to avoid identification of patients, no results will be entered.
- 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-colorectal-neoplasm
- nct id
- NCT00903396
- harm key
- EG002
- source section id
- NCT00903396-ae
- event group key
- EG002
- event group label
- Arm III
- serious affected
- 0
- serious at risk
- 0
- other affected
- 0
- other at risk
- 0
- frequency threshold
- 0
- collection period
- Source null
- event definition
- Not enough patients were accrued. In order to avoid identification of patients, no results will be entered.
- 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-colorectal-neoplasm
- nct id
- NCT00903396
- harm key
- EG003
- source section id
- NCT00903396-ae
- event group key
- EG003
- event group label
- Arm IV
- serious affected
- 0
- serious at risk
- 0
- other affected
- 0
- other at risk
- 0
- frequency threshold
- 0
- collection period
- Source null
- event definition
- Not enough patients were accrued. In order to avoid identification of patients, no results will be entered.
- 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
- setting source links
Preserved source evidence · Not medical advice