Study of Postoperative Concurrent Chemo-radiation With Capecitabine in Elderly Rectal Cancer Patients
Condition: Rectal Neoplasms
MeSH terms: Rectal Neoplasms
Intervention: Capecitabine; Capecitabine; Capecitabine; Capecitabine
Intervention description: oral pills, 1000mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation.; oral pills, 1200mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation.; oral pills, 1400mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation.; oral pills, 1500mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation.
Intervention MeSH terms: Capecitabine
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: All
Minimum age: 71 Years
Healthy volunteers: No
Keywords: rectal neoplasms; aged; radiotherapy; drug therapy; dose-escalation; capecitabine

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.