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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jing Jin, M.D., Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01268943
First received: December 28, 2010
Last updated: January 26, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Rectal Neoplasms
Drug: Capecitabine
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 1 Study of Postoperative Capecitabine With Concurrent Radiation in Elderly With Stage II/III Rectal Cancer

Resource links provided by NLM:


Further study details as provided by Chinese Academy of Medical Sciences:

Primary Outcome Measures:
  • dose related toxicity [ Time Frame: up to 9 weeks ] [ Designated as safety issue: Yes ]
    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


Enrollment: 21
Study Start Date: November 2010
Study Completion Date: January 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1000mg
capecitabine 1000mg/m2/d d1-14, d22-35 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: stair 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: stair 2
Experimental: 1400mg
capecitabine 1400mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.
Drug: Capecitabine
oral pills, 1400mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation.
Other Name: stair 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: stair 4
Experimental: 1600mg
capecitabine 1600mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.
Drug: Capecitabine
oral pills, 1600mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation.
Other Name: stair 5
Experimental: 1700mg
capecitabine 1700mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.
Drug: Capecitabine
oral pills, 1700mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation.
Other Name: stair 6
Experimental: 1800mg
capecitabine 1800mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.
Drug: Capecitabine
oral pills, 1800mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation.
Other Name: stair 7
Experimental: 1900mg
capecitabine 1900mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.
Drug: Capecitabine
oral pills, 1900mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation.
Other Name: stair 8
Experimental: 2000mg
capecitabine 2000mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.
Drug: Capecitabine
oral pills, 1900mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation.
Other Name: stair 9

Detailed Description:

For those "younger" locally advanced (stage II/III) rectal cancer patients (usually means patients less than 70), it is suggested that after radical surgery, patients should receive concurrent chemo-radiation. Capecitabine is a widely used chemotherapy medicine under such condition. Based on experience, the investigators think this modality can also be tolerated by patients over 70, and will increase local control rate as which has been proved in younger ones. As the first step to test this hypothesis, we designed this phase I study to seek the proper dose of capecitabine, a widely used oral chemotherapy medicine, in postoperative concurrent chemo-radiation for stage II/III rectal cancer patients over 70, and to evaluate the safety of this modality in this group of patients.

  Eligibility

Ages Eligible for Study:   71 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01268943

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. radiation department, cancer hospital, CAMS
Principal Investigator: Yexiong Li, Ph.D. Radiation Department, Cancer Hospital, CAMS
  More Information

Publications:

Responsible Party: Jing Jin, M.D., vice chair of radiation department, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier: NCT01268943     History of Changes
Other Study ID Numbers: CH-GI-013
Study First Received: December 28, 2010
Last Updated: January 26, 2014
Health Authority: China: Food and Drug Administration

Keywords provided by Chinese Academy of Medical Sciences:
rectal neoplasms
aged
radiotherapy
drug therapy
dose-escalation
capecitabine

Additional relevant MeSH terms:
Neoplasms
Rectal Neoplasms
Colorectal Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms by Site
Rectal Diseases
Capecitabine
Fluorouracil
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 23, 2014