We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Safety Study of Capecitabine With Radiation in Elderly Rectal Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01584544
First Posted: April 25, 2012
Last Update Posted: May 7, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Jing Jin, M.D., Chinese Academy of Medical Sciences
  Purpose
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.

Condition Intervention Phase
Rectal Neoplasms Drug: capecitabine Drug: Capecitabine Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Study of Preoperative Concurrent Chemo-radiation With Capecitabine in Elderly Rectal Cancer Patients

Resource links provided by NLM:


Further study details as provided by Jing Jin, M.D., Chinese Academy of Medical Sciences:

Primary Outcome Measures:
  • 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


Enrollment: 24
Study Start Date: January 2011
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: stare 2
Experimental: 1350mg
capecitabine 1300mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.
Drug: Capecitabine
oral pills, 1350mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation
Other Name: stare 3
Experimental: 1500mg
capecitabine 1500mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.
Drug: Capecitabine
oral pills, 1500mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation
Other Name: stare 4
Experimental: 1650mg
capecitabine 1650mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.
Drug: Capecitabine
oral pills, 1650mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation
Other Name: stare 5

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   75 Years and older   (Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01584544


Locations
China, Beijing
radiation department, Cancer Hospital, CAMS
Beijing, Beijing, China, 100021
Sponsors and Collaborators
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
  More Information

Publications:

Responsible Party: Jing Jin, M.D., vice chair of radiation department, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier: NCT01584544     History of Changes
Other Study ID Numbers: CH-GI-024
First Submitted: April 20, 2012
First Posted: April 25, 2012
Results First Submitted: April 7, 2015
Results First Posted: April 20, 2015
Last Update Posted: May 7, 2015
Last Verified: April 2015

Keywords provided by Jing Jin, M.D., Chinese Academy of Medical Sciences:
rectal neoplasms
aged
chemoradiotherapy
clinical trials, phase I
capecitabine

Additional relevant MeSH terms:
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Capecitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents