Safety Study of Capecitabine With Radiation in Elderly Rectal Cancer

April 17, 2015 updated by: Jing Jin, M.D., Cancer Institute and Hospital, Chinese Academy of Medical Sciences

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100021
        • radiation department, Cancer Hospital, CAMS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

75 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1000mg
capecitabine 1000mg/m2/d d1-14, d22-25 combined with concurrent radiotherapy will be given to enrolled patients.
Drug: capecitabine
oral pills, 1000mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation
Other Names:
  • stare 1
Experimental: 1200mg
capecitabine 1200mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.
Drug: Capecitabine
oral pills, 1200mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation
Other Names:
  • stare 2
Drug: Capecitabine
oral pills, 1350mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation
Other Names:
  • stare 3
Drug: Capecitabine
oral pills, 1500mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation
Other Names:
  • stare 4
Drug: Capecitabine
oral pills, 1650mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation
Other Names:
  • stare 5
Experimental: 1350mg
capecitabine 1300mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.
Drug: Capecitabine
oral pills, 1200mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation
Other Names:
  • stare 2
Drug: Capecitabine
oral pills, 1350mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation
Other Names:
  • stare 3
Drug: Capecitabine
oral pills, 1500mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation
Other Names:
  • stare 4
Drug: Capecitabine
oral pills, 1650mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation
Other Names:
  • stare 5
Experimental: 1500mg
capecitabine 1500mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.
Drug: Capecitabine
oral pills, 1200mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation
Other Names:
  • stare 2
Drug: Capecitabine
oral pills, 1350mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation
Other Names:
  • stare 3
Drug: Capecitabine
oral pills, 1500mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation
Other Names:
  • stare 4
Drug: Capecitabine
oral pills, 1650mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation
Other Names:
  • stare 5
Experimental: 1650mg
capecitabine 1650mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.
Drug: Capecitabine
oral pills, 1200mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation
Other Names:
  • stare 2
Drug: Capecitabine
oral pills, 1350mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation
Other Names:
  • stare 3
Drug: Capecitabine
oral pills, 1500mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation
Other Names:
  • stare 4
Drug: Capecitabine
oral pills, 1650mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation
Other Names:
  • stare 5

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Experienced Dose Limited Toxicity
Time Frame: up to 7 weeks from start of the treatment
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
up to 7 weeks from start of the treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Investigators

  • Principal Investigator: Jing Jin, Ph.D., Chinese Academic Medical Science
  • Principal Investigator: Yexiong Li, Ph.D., Chinese Academic Medical Science

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

May 1, 2014

Study Completion (Actual)

May 1, 2014

Study Registration Dates

First Submitted

April 20, 2012

First Submitted That Met QC Criteria

April 23, 2012

First Posted (Estimate)

April 25, 2012

Study Record Updates

Last Update Posted (Estimate)

April 20, 2015

Last Update Submitted That Met QC Criteria

April 17, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CH-GI-024

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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