Study of Postoperative Concurrent Chemo-radiation With Capecitabine in Elderly Rectal Cancer Patients

NCT01268943 | Completed Phase 1 Results

• 1 other identifier: CH-GI-013
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Rectal Neoplasms

Keywords

rectal neoplasms; aged; radiotherapy; drug therapy; dose-escalation; capecitabine

Outcome Measures

Primary Outcomes (1)

• 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

  up to 9 weeks

Study Arms (4)

1000mg

EXPERIMENTAL

capecitabine 1000mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.

Drug: Capecitabine

1200mg

EXPERIMENTAL

capecitabine 1200mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.

Drug: Capecitabine

1400mg

EXPERIMENTAL

capecitabine 1400mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.

Drug: Capecitabine

1500mg

EXPERIMENTAL

capecitabine 1500mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.

Drug: Capecitabine

Interventions

Capecitabine DRUG

oral pills, 1000mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation.

Also known as: stair 1

1000mg

Eligibility Criteria

• Age: 71 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese Academy of Medical Sciences: lead

Study Sites (1)

radiation department, Cancer Hospital, CAMS

Beijing, Beijing Municipality, 100021, China

Location

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MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Capecitabine

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Results Point of Contact

• Title: Dr. Jing Jin
• Organization: Chinese Academic Medical Sciences

tangyu.pumc@gmail.com

010-87788503

Study Officials

• Jing Jin, Ph.D.

  radiation department, cancer hospital, CAMS

  PRINCIPAL INVESTIGATOR

• Yexiong Li, Ph.D.

  Radiation Department, Cancer Hospital, CAMS

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: vice chair of radiation department

Study Record Dates

• First Submitted: December 28, 2010
• First Posted: January 4, 2011
• Study Start: November 1, 2010
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: April 6, 2015
• Results First Posted: March 17, 2015

Record last verified: 2015-03

Locations

CN (1)