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Phase 1 Study of Postoperative Capecitabine With Concurrent Radiation in Elderly With Stage II/III Rectal Cancer

Phase 1
71 Years
Open (Enrolling)
Rectal Neoplasms

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Trial Information

Phase 1 Study of Postoperative Capecitabine With Concurrent Radiation in Elderly With Stage II/III Rectal Cancer

For those "younger" locally advanced (stage II/III) rectal cancer patients (usually means
patients less than 70), it is suggested that after radical surgery, patients should receive
concurrent chemo-radiation. Capecitabine is a widely used chemotherapy medicine under such
condition. Based on experience, the investigators think this modality can also be tolerated
by patients over 70, and will increase local control rate as which has been proved in
younger ones. As the first step to test this hypothesis, we designed this phase I study to
seek the proper dose of capecitabine, a widely used oral chemotherapy medicine, in
postoperative concurrent chemo-radiation for stage II/III rectal cancer patients over 70,
and to evaluate the safety of this modality in this group of patients.

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

- 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

- 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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

dose related toxicity

Outcome Description:

dose related toxicity is defined as follows:1. WBC damage >= grade 3; granular cell decrease >= grade 3; hemoglobin >= grade 2; platelet >= grade 2;SGPT/SGOT elevation >= grade 2; ALP >= grade 2; GGT >= grade 2; Tbil >= grade 2;renal function damage: BUN/Cr elevation >= grade 2;Non-gradular cell decreased fever >= grade 2;nausea/vomiting >= grade 2; fatigue >= grade 3; weight loss >= grade 3;gastritis >= grade 3; dairrea >= grade 3; abdominal pain >= grade 3; pancreatitis >= grade 2; upper gastrointestinal bleeding >= grade 2;other toxic reaction >= grade 3;KPS < 50 during the treatment

Outcome Time Frame:

up to 9 weeks

Safety Issue:


Principal Investigator

Jing Jin, Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

radiation department, cancer hospital, CAMS


China: Food and Drug Administration

Study ID:




Start Date:

November 2010

Completion Date:

December 2014

Related Keywords:

  • Rectal Neoplasms
  • rectal neoplasms
  • aged
  • radiotherapy
  • drug therapy
  • dose-escalation
  • capecitabine
  • Neoplasms
  • Rectal Neoplasms