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Safety Study of Capecitabine With Radiation in Elderly Rectal Cancer

Primary Purpose

Rectal Neoplasms

Status

Completed

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

capecitabine

Capecitabine

About this trial

This is an interventional treatment trial for Rectal Neoplasms focused on measuring rectal neoplasms, aged, chemoradiotherapy, clinical trials, phase I, capecitabine

Eligibility Criteria

75 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

rectal adenocarcinoma, clinical stage II/III(T3-4 or N+, AJCC 7th).
KPS status no less than 70; Charlson comorbidity no more than 3.
life expectancy more than 6 months.
hemoglobin >= 100g/L, white blood cell >= 3.5*10E9/L, neutrophil >= 1.5*10E9/L, platelet >= 100*10E9/L.Creatin normal, Total bilirubin normal, AST and AST normal, AKP normal.
do not have allergy history to thymidine phosphorylase.
do not receive surgery ( except palliative colostomy) or chemotherapy or other anti-cancer treatment
no previously pelvic irradiation history
informed consent signed

Exclusion Criteria:

other cancer history, except curable non-melanoma skin cancer or cervix in-situ carcinoma
previous pelvic irradiation history
receiving surgery (except palliative colostomy), chemotherapy or other anti-cancer treatment
allergy history to thymidine phosphorylase
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.
anticipate other clinical trials in four weeks before enrollment

Sites / Locations

radiation department, Cancer Hospital, CAMS

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Arm Label

1000mg

1200mg

1350mg

1500mg

1650mg

Arm Description

capecitabine 1000mg/m2/d d1-14, d22-25 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 1300mg/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.

capecitabine 1650mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.

Outcomes

Primary Outcome Measures

Number of Participants Experienced Dose Limited Toxicity

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

Secondary Outcome Measures

Full Information

NCT ID

NCT01584544

First Posted

April 20, 2012

Last Updated

April 17, 2015

Sponsor

Chinese Academy of Medical Sciences

1. Study Identification

Unique Protocol Identification Number

NCT01584544

Brief Title

Safety Study of Capecitabine With Radiation in Elderly Rectal Cancer

Official Title

Phase I Study of Preoperative Concurrent Chemo-radiation With Capecitabine in Elderly Rectal Cancer Patients

Study Type

Interventional

2. Study Status

Record Verification Date

April 2015

Overall Recruitment Status

Completed

Study Start Date

January 2011 (undefined)

Primary Completion Date

May 2014 (Actual)

Study Completion Date

May 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

Yes

5. Study Description

Brief Summary

This phase I study is designed to determine the maximum tolerant dose of capecitabine when used in preoperative concurrent chemo-radiation for locally advanced rectal patients over 75 years old.

Detailed Description

It is proved that preoperative concurrent chemo-radiotherapy can improve both local control and overall survival in stage II/III rectal cancer patients. But elderly patients, especially patients over 75 years were hardly involved in related clinical trials considered of their fragility. Several retrospective study showed that old rectal cancer patients would also benefit from concurrent chemo-radiation, with acceptable toxicity. Several new drug, such as capecitabine, also seem to be safety for elderly cancer patients. But few prospective study has been carried out. The investigators designed this phase I study, to explore the maximum tolerant dose of capecitabine in preoperative concurrent chemoradiation for elderly stage II/III rectal cancer patients, as well as to evaluate safety.

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, chemoradiotherapy, clinical trials, phase I, 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

24 (Actual)

8. Arms, Groups, and Interventions

Arm Title

1000mg

Arm Type

Experimental

Arm Description

capecitabine 1000mg/m2/d d1-14, d22-25 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

1350mg

Arm Type

Experimental

Arm Description

capecitabine 1300mg/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.

Arm Title

1650mg

Arm Type

Experimental

Arm Description

capecitabine 1650mg/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)

stare 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)

stare 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)

stare 3

Intervention Description

oral pills, 1350mg/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)

stare 4

Intervention Description

oral pills, 1500mg/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)

stare 5

Intervention Description

oral pills, 1650mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation

Primary Outcome Measure Information:

Title

Number of Participants Experienced Dose Limited Toxicity

Description

Time Frame

up to 7 weeks from start of the treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: rectal adenocarcinoma, clinical stage II/III(T3-4 or N+, AJCC 7th). KPS status no less than 70; Charlson comorbidity no more than 3. life expectancy more than 6 months. hemoglobin >= 100g/L, white blood cell >= 3.5*10E9/L, neutrophil >= 1.5*10E9/L, platelet >= 100*10E9/L.Creatin normal, Total bilirubin normal, AST and AST normal, AKP normal. do not have allergy history to thymidine phosphorylase. do not receive surgery ( except palliative colostomy) or chemotherapy or other anti-cancer treatment no previously pelvic irradiation history informed consent signed Exclusion Criteria: other cancer history, except curable non-melanoma skin cancer or cervix in-situ carcinoma previous pelvic irradiation history receiving surgery (except palliative colostomy), chemotherapy or other anti-cancer treatment allergy history to thymidine phosphorylase 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. anticipate other clinical trials in four weeks before enrollment

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jing Jin, Ph.D.

Organizational Affiliation

Chinese Academic Medical Science

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Yexiong Li, Ph.D.

Organizational Affiliation

Chinese Academic Medical Science

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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Safety Study of Capecitabine With Radiation in Elderly Rectal Cancer

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