TriangleNCT00525785 · STUDY IN CONTEXT
Preoperative Chemo and Chemoradiotherapy for Adenocarcinoma of the Stomach and Gastroesophageal Junction (GEJ)
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. 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
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-gastric-cancer
- nct id
- NCT00525785
- trial label
- Preoperative Chemo and Chemoradiotherapy for Adenocarcinoma of the Stomach and Gastroesophageal Junction (GEJ)
- 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.
- 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
- 1
- harms Count
- 1
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-gastric-cancer
- nct id
- NCT00525785
- outcome key
- om-0000
- source section id
- NCT00525785-om-0000
- source outcome index
- 0
- endpoint
- Complete Pathologic Response Rate
- endpoint definition
- The complete pathologic response (path CR) rate after treatment calculated as the percentage of participants with path CR out of the total participants, where the path CR is defined as absence of tumor cells in the surgical specimen and all registered participants are used in the denominator for calculating the path CR rate. Primary gastric carcinoma is not measurable by conventional criteria thus usual response criteria cannot be applied. The following criteria for response assessment applied: Pathologic Complete Response: Absence of tumor cells in the surgical specimen, 95% or more necrosis of the cancer; Complete Clinical Response: Absence of tumor on endoscopy, biopsy, cytology, or both.
- time origin
- Restaging and surgical resection at 4-6 weeks after completion of chemoradiotherapy, approximately at 16 weeks into treatment
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Source null
- 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-gastric-cancer
- nct id
- NCT00525785
- outcome key
- om-0000
- arm key
- OG000
- arm label
- 5-Fluorouracil + Folinic Acid + Oxaliplatin
- regimen
- FOLFOX-48 PreOp Chemotherapy (2 Cycles) with oxaliplatin, folinic acid \& infusional 5-FU repeated every 2 weeks x 4 (8 weeks of induction chemotherapy). PreOp Chemoradiotherapy following PreOp Chemo 5FU plus oxaliplatin for total 45 Gy (1.8 Gy fx/d) of radiotherapy concurrent to low-dose continuous infusion of 5-FU (300 mg/m\^2 for 5 days) \& weekly oxaliplatin 45 mg/m\^2 for 5 weeks (oxaliplatin administered on the first day of radiation week). Surgical resection 4-6 weeks after completion of chemoradiotherapy.
- analyzed count
- 58
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00525785-om-0000#groups/OG000
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-gastric-cancer
- nct id
- NCT00525785
- harm key
- EG000
- source section id
- NCT00525785-ae
- event group key
- EG000
- event group label
- 5-Fluorouracil + Folinic Acid + Oxaliplatin
- serious affected
- 4
- serious at risk
- 58
- other affected
- 42
- other at risk
- 58
- frequency threshold
- 5
- collection period
- Adverse event collection during 16 week+ treatment period using Common Toxicity Criteria (CTC) to score chemotherapy events and acute radiation (< 90 days) toxicities.
- event definition
- Regular investigator assessment, regular laboratory testing, and routine questioning of participants during treatment and visits used for determination of adverse events.
- 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