Study of Postoperative Concurrent Chemo-radiation With Capecitabine in Elderly Rectal Cancer Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jing Jin, M.D., Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01268943
First received: December 28, 2010
Last updated: January 26, 2014
Last verified: January 2014

December 28, 2010
January 26, 2014
November 2010
January 2014   (final data collection date for primary outcome measure)
dose related toxicity [ Time Frame: up to 9 weeks ] [ Designated as safety issue: Yes ]
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
Same as current
Complete list of historical versions of study NCT01268943 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Study of Postoperative Concurrent Chemo-radiation With Capecitabine in Elderly Rectal Cancer Patients
Phase 1 Study of Postoperative Capecitabine With Concurrent Radiation in Elderly With Stage II/III Rectal Cancer

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.

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.

Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Rectal Neoplasms
  • Drug: Capecitabine
    oral pills, 1000mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation.
    Other Name: stair 1
  • Drug: Capecitabine
    oral pills, 1200mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation.
    Other Name: stair 2
  • Drug: Capecitabine
    oral pills, 1400mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation.
    Other Name: stair 3
  • Drug: Capecitabine
    oral pills, 1500mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation.
    Other Name: stair 4
  • Drug: Capecitabine
    oral pills, 1600mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation.
    Other Name: stair 5
  • Drug: Capecitabine
    oral pills, 1700mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation.
    Other Name: stair 6
  • Drug: Capecitabine
    oral pills, 1800mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation.
    Other Name: stair 7
  • Drug: Capecitabine
    oral pills, 1900mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation.
    Other Name: stair 8
  • Drug: Capecitabine
    oral pills, 1900mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation.
    Other Name: stair 9
  • Experimental: 1000mg
    capecitabine 1000mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.
    Intervention: Drug: Capecitabine
  • Experimental: 1200mg
    capecitabine 1200mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.
    Intervention: Drug: Capecitabine
  • Experimental: 1400mg
    capecitabine 1400mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.
    Intervention: Drug: Capecitabine
  • Experimental: 1500mg
    capecitabine 1500mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.
    Intervention: Drug: Capecitabine
  • Experimental: 1600mg
    capecitabine 1600mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.
    Intervention: Drug: Capecitabine
  • Experimental: 1700mg
    capecitabine 1700mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.
    Intervention: Drug: Capecitabine
  • Experimental: 1800mg
    capecitabine 1800mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.
    Intervention: Drug: Capecitabine
  • Experimental: 1900mg
    capecitabine 1900mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.
    Intervention: Drug: Capecitabine
  • Experimental: 2000mg
    capecitabine 2000mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.
    Intervention: Drug: Capecitabine

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
21
January 2014
January 2014   (final data collection date for primary outcome measure)

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.
Both
71 Years and older
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01268943
CH-GI-013
No
Jing Jin, M.D., Chinese Academy of Medical Sciences
Chinese Academy of Medical Sciences
Not Provided
Principal Investigator: Jing Jin, Ph.D. radiation department, cancer hospital, CAMS
Principal Investigator: Yexiong Li, Ph.D. Radiation Department, Cancer Hospital, CAMS
Chinese Academy of Medical Sciences
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP