Safety Study of Capecitabine With Radiation in Elderly Rectal Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Chinese Academy of Medical Sciences
Sponsor:
Information provided by (Responsible Party):
Jing Jin, M.D., Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01584544
First received: April 20, 2012
Last updated: September 17, 2013
Last verified: September 2013

April 20, 2012
September 17, 2013
January 2011
December 2013   (final data collection date for primary outcome measure)
number of patients suffering dose limited toxicity [ Time Frame: up to 7 weeks from start of the treatment ] [ Designated as safety issue: Yes ]
more than 1/3 patients suffer DLT means the end of the trial.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
Same as current
Complete list of historical versions of study NCT01584544 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Safety Study of Capecitabine With Radiation in Elderly Rectal Cancer
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.

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.

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: stare 1
  • Drug: Capecitabine
    oral pills, 1200mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation
    Other Name: stare 2
  • Drug: Capecitabine
    oral pills, 1350mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation
    Other Name: stare 3
  • Drug: Capecitabine
    oral pills, 1500mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation
    Other Name: stare 4
  • Drug: Capecitabine
    oral pills, 1650mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation
    Other Name: stare 5
  • Experimental: 1000mg
    capecitabine 1000mg/m2/d d1-14, d22-25 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: 1350mg
    capecitabine 1300mg/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: 1650mg
    capecitabine 1650mg/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.
 
Recruiting
20
December 2013
December 2013   (final data collection date for primary outcome measure)

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
Both
76 Years and older
No
Contact: Yu Tang, Ph.D. 8613521662807 tangyu.pumc@gmail.com
Contact: Wenyang Liu, Ph.D. 8601087788504
China
 
NCT01584544
CH-GI-024
Yes
Jing Jin, M.D., Chinese Academy of Medical Sciences
Chinese Academy of Medical Sciences
Not Provided
Principal Investigator: Jing Jin, Ph.D. Chinese Academic Medical Science
Principal Investigator: Yexiong Li, Ph.D. Chinese Academic Medical Science
Chinese Academy of Medical Sciences
September 2013

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