Study of Postoperative Concurrent Chemo-radiation With Capecitabine in Elderly Rectal Cancer Patients
Primary Purpose
Rectal Neoplasms
Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Capecitabine
Capecitabine
Capecitabine
Capecitabine
Sponsored by
About this trial
This is an interventional treatment trial for Rectal Neoplasms focused on measuring rectal neoplasms, aged, radiotherapy, drug therapy, dose-escalation, capecitabine
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.
Sites / Locations
- radiation department, Cancer Hospital, CAMS
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
1000mg
1200mg
1400mg
1500mg
Arm Description
capecitabine 1000mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.
capecitabine 1200mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.
capecitabine 1400mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.
capecitabine 1500mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.
Outcomes
Primary Outcome Measures
Dose Related Toxicity
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
Secondary Outcome Measures
Full Information
NCT ID
NCT01268943
First Posted
December 28, 2010
Last Updated
March 17, 2015
Sponsor
Chinese Academy of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT01268943
Brief Title
Study of Postoperative Concurrent Chemo-radiation With Capecitabine in Elderly Rectal Cancer Patients
Official Title
Phase 1 Study of Postoperative Capecitabine With Concurrent Radiation in Elderly With Stage II/III Rectal Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
January 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese Academy of Medical Sciences
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Neoplasms
Keywords
rectal neoplasms, aged, radiotherapy, drug therapy, dose-escalation, capecitabine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1000mg
Arm Type
Experimental
Arm Description
capecitabine 1000mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.
Arm Title
1200mg
Arm Type
Experimental
Arm Description
capecitabine 1200mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.
Arm Title
1400mg
Arm Type
Experimental
Arm Description
capecitabine 1400mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.
Arm Title
1500mg
Arm Type
Experimental
Arm Description
capecitabine 1500mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.
Intervention Type
Drug
Intervention Name(s)
Capecitabine
Other Intervention Name(s)
stair 1
Intervention Description
oral pills, 1000mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation.
Intervention Type
Drug
Intervention Name(s)
Capecitabine
Other Intervention Name(s)
stair 2
Intervention Description
oral pills, 1200mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation.
Intervention Type
Drug
Intervention Name(s)
Capecitabine
Other Intervention Name(s)
stair 3
Intervention Description
oral pills, 1400mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation.
Intervention Type
Drug
Intervention Name(s)
Capecitabine
Other Intervention Name(s)
stair 4
Intervention Description
oral pills, 1500mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation.
Primary Outcome Measure Information:
Title
Dose Related Toxicity
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
Time Frame
up to 9 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
71 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jing Jin, Ph.D.
Organizational Affiliation
radiation department, cancer hospital, CAMS
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yexiong Li, Ph.D.
Organizational Affiliation
Radiation Department, Cancer Hospital, CAMS
Official's Role
Principal Investigator
Facility Information:
Facility Name
radiation department, Cancer Hospital, CAMS
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100021
Country
China
12. IPD Sharing Statement
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Study of Postoperative Concurrent Chemo-radiation With Capecitabine in Elderly Rectal Cancer Patients
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