Phase 1
N=18
Study of Postoperative Concurrent Chemo-radiation With Capecitabine in Elderly Rectal Cancer Patients
Rectal Neoplasms
Bottom Line
View on ClinicalTrials.gov: NCT01268943 ↗Enrolled (actual)
18
Serious AEs
16.7%
Results posted
Mar 2015
Primary outcome: Primary: Dose Related Toxicity — 1; 0; 0; 3 event
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Capecitabine (Drug)
- Age
- Older Adult · 71+ yrs
- Sex
- All
- Sponsor
- Chinese Academy of Medical Sciences
- Primary completion
- Jan 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Dose Related Toxicity |
1; 0; 0; 3 | — |
Summary
The purpose of this study is to seek the proper dose of capecitabine in post-operative concurrent chemotherapy for stage II/III elderly rectal cancer patients receiving radical surgery, and evaluate the toleration of this modality in such patients.
Eligibility Criteria
Inclusion Criteria
- rectal adenocarcinoma, pathological stage II/III(T3-4 or N+, UICC 2002), radical surgery received.
- interval between surgery and enrollment no less than two week and no more than 3 months.
- KPS status no less than 70; life expectancy no less than 6 months.
- without life-threatening complications, such as severe hypertension, coronary heart disease, cerebral vascular disease, uncontrolled diabetes, etc.
- without severe drug allergy history.
- hemoglobin >= 100g/L, white blood cell >= 3.5*10E9/L, neutrophil >= 1.5*10E9/L, platelet >= 100*10E9/L.
- Creatin <= 1.5* ULN(upper limit of normal), Total bilirubin <= 2.5 ULN, AST and AST <= 2.5* ULN, AKP <= 2.5*ULN
- do not receive chemotherapy before six months from enrollment.
- no previously pelvic irradiation history
- informed consent signed
Exclusion Criteria
- other cancer history, except curable non-melanoma skin cancer or cervix in-situ carcinoma
- allergy history to thymidine phosphorylase
- previous pelvic irradiation history
- receiving adjuvant chemotherapy in six months before enrollment
- 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.
- life expectancy less than 6 months
- estimated cannot finish treatment
- attend other clinical trials in four weeks before enrollment
- receive other anti-cancer treatment currently
- other conditions which regarded illegal by censors with full reasons. for example, some conditions may conflict from the protocol.
Data sourced from ClinicalTrials.gov (NCT01268943). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.