Clinical trial · Observational
Tumor Response Prediction in Neoadjuvant Chemoradiation of Locally Advanced Rectal Cancer Using Metabonomics Analysis
NCT03149978CI-TRIAL-00027546unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study suggested an effective application of pattern recognition, which figured the possible biological function of potential bio-markers of rectal cancer found in our study based on their chemical structures. Hence, this study identified the precursor protein and metabolic mechanism of these bio-markers and may contribute to the neoadjuvant chemoradiation of locally advanced rectal cancer
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Locally Advanced Rectal Cancer | Malignant Rectal Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- TRG
- timeFrame
- Surgery scheduled 6-8 weeks after the end of chemoradiation
- description
- Tumor regression grade
Secondary outcomes (5)
- measure
- Pathologic Complete Response
- timeFrame
- Surgery scheduled 6-8 weeks after the end of chemoradiation
- measure
- Local Control rate
- timeFrame
- From date of randomization until the date of first documented pelvic failure, assessed up to 10 years
- description
- Number of participants with pelvic failure after surgery, evaluated using Kaplan-Meier Curve
- measure
- Disease-free Survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. history of primary rectal cancer with distance from anal verge being less than 12 cm; 2. histologically confirmed adenocarcinoma; 3. initial pathological stage of T3 or T4 and/or N+; 4. no history of initial distant metastases; 5. Karnofsky Performance Status score of ≥75 6. ≥18 years;≤75 years 7. sign the inform consent Exclusion Criteria: 1. pregnancy or breast-feeding women 2. serious medical illness 3. baseline blood and biochemical indicators do not meet the following criteria: neutrophils≥1.5×10\^9/L, Hb≥90g/L, PLT≥100×10\^9/L, ALT/AST ≤2.5 ULN, Cr≤ 1 ULN
References
Publications (1)
- DERIVEDJia H, Shen X, Guan Y, Xu M, Tu J, Mo M, Xie L, Yuan J, Zhang Z, Cai S, Zhu J, Zhu Z. Predicting the pathological response to neoadjuvant chemoradiation using untargeted metabolomics in locally advanced rectal cancer. Radiother Oncol. 2018 Sep;128(3):548-556. doi: 10.1016/j.radonc.2018.06.022. Epub 2018 Jul 2. PMID 30041962