Clinical trial · Interventional
Safety Study of Capecitabine With Radiation in Elderly Rectal Cancer
Phase I Study of Preoperative Concurrent Chemo-radiation With Capecitabine in Elderly Rectal Cancer Patients
NCT01584544CI-TRIAL-00017574completedPhase 1Results postedClinicalTrials.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 phase I study is designed to determine the maximum tolerant dose of capecitabine when used in preoperative concurrent chemo-radiation for locally advanced rectal patients over 75 years old.
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 |
|---|---|---|---|
| Rectal Neoplasms | Rectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| capecitabine | Drug | Capecitabine | ALIAS |
Design
Arms and outcomes
Arms (5)
- type
- EXPERIMENTAL
- label
- 1000mg
- description
- capecitabine 1000mg/m2/d d1-14, d22-25 combined with concurrent radiotherapy will be given to enrolled patients.
- interventionNames
- Drug: capecitabine
- type
- EXPERIMENTAL
- label
- 1200mg
- description
- capecitabine 1200mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.
- interventionNames
- Drug: Capecitabine
- type
- EXPERIMENTAL
- label
- 1350mg
- description
- capecitabine 1300mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * rectal adenocarcinoma, clinical stage II/III(T3-4 or N+, AJCC 7th). * KPS status no less than 70; Charlson comorbidity no more than 3. * life expectancy more than 6 months. * hemoglobin \>= 100g/L, white blood cell \>= 3.5\*10E9/L, neutrophil \>= 1.5\*10E9/L, platelet \>= 100\*10E9/L.Creatin normal, Total bilirubin normal, AST and AST normal, AKP normal. * do not have allergy history to thymidine phosphorylase. * do not receive surgery ( except palliative colostomy) or chemotherapy or other anti-cancer treatment * no previously pelvic irradiation history * informed consent signed Exclusion Criteria: * other cancer history, except curable non-melanoma skin cancer or cervix in-situ carcinoma * previous pelvic irradiation history * receiving surgery (except palliative colostomy), chemotherapy or other anti-cancer treatment * allergy history to thymidine phosphorylase * active infection existed * severe complication, such as acute myocardial infarction in 6 months, uncontrolled diabetes ( Plasma glucose concentrations in any time of a day≥11.1mmol/L）, severe cardiac arrhythmia， etc. * anticipate other clinical trials in four weeks before enrollment
References
Publications (54)
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- BACKGROUNDChang GJ, Skibber JM, Feig BW, Rodriguez-Bigas M. Are we undertreating rectal cancer in the elderly? An epidemiologic study. Ann Surg. 2007 Aug;246(2):215-21. doi: 10.1097/SLA.0b013e318070838f. PMID 17667499
- BACKGROUNDTownsley C, Pond GR, Peloza B, Kok J, Naidoo K, Dale D, Herbert C, Holowaty E, Straus S, Siu LL. Analysis of treatment practices for elderly cancer patients in Ontario, Canada. J Clin Oncol. 2005 Jun 1;23(16):3802-10. doi: 10.1200/JCO.2005.06.742.