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Intensity-Modulated Radiation Therapy With Incorporated Boost and Capecitabine Before Surgery in Treating Patients With Locally Advanced Rectal Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Fox Chase Cancer Center
ClinicalTrials.gov Identifier:
NCT00084591
First received: June 10, 2004
Last updated: February 11, 2010
Last verified: February 2010
  Purpose

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Intensity-modulated radiation therapy (radiation directed at the tumor more precisely than in standard radiation therapy) with incorporated boost (an increase in the amount of radiation given during treatment) may cause less damage to normal tissue. Drugs used in chemotherapy, such as capecitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving radiation therapy together with chemotherapy before surgery may shrink the tumor so it can be removed.

PURPOSE: This phase I trial is studying the side effects and best dose of neoadjuvant intensity-modulated radiation therapy with incorporated boost when given together with capecitabine in treating patients with locally advanced rectal cancer.


Condition Intervention Phase
Colorectal Cancer
Drug: capecitabine
Procedure: conventional surgery
Procedure: neoadjuvant therapy
Radiation: radiation therapy
Phase 1

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Phase I Study of Preoperative Intensity Modulated Radiation Therapy (IMRT) With Incorporated Boost and Oral Capecitabine in Locally Advanced Rectal Cancer

Resource links provided by NLM:


Further study details as provided by Fox Chase Cancer Center:

Primary Outcome Measures:
  • Acute toxicity by CTCAE at 6 weeks following study completion [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Quality of life as assessed by Quality of Life Questionnaire Core 30 Items (QLQ-C30) before and after radiotherapy and then every 6 months after surgery [ Designated as safety issue: No ]

Study Start Date: December 2003
Study Completion Date: February 2007
Detailed Description:

OBJECTIVES:

Primary

  • Determine the maximum tolerated dose of neoadjuvant boost intensity-modulated radiotherapy when combined with capecitabine before surgery in patients with locally advanced rectal cancer.

Secondary

  • Determine the pathologic tumor response in patients treated with this regimen.
  • Determine the quality of life of patients treated with this regimen.

OUTLINE: This is a dose-escalation study of boost intensity-modulated radiotherapy (IMRT).

Patients undergo neoadjuvant IMRT with incorporated boost once daily 5 days a week for 5 weeks. Beginning on the first day of radiotherapy, patients receive oral capecitabine twice daily 7 days a week for 5 weeks. Patients undergo surgical resection 4-8 weeks after completion of chemoradiotherapy.

Cohorts of 3-6 patients undergo escalating doses of boost IMRT until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 3 of 6 patients experience dose-limiting toxicity.

Quality of life is assessed at baseline, at week 5 of chemoradiotherapy, before surgery, and then at 1, 3, and 12 months after surgery.

Patients are followed at 1, 3, and 12 months after surgery.

PROJECTED ACCRUAL: Approximately 3-15 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed primary adenocarcinoma of the rectum

    • Distal border of the tumor within 12 cm of the anal verge by proctoscopic exam
    • Clinical stage T3-4, N1-2 (stage II or III) disease by 2 of the following tests:

      • Physical exam
      • Transrectal ultrasound
      • Pelvic CT scan
      • Pelvic MRI
  • No clinical evidence of metastatic disease

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-1

Life expectancy

  • More than 3 months

Hematopoietic

  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • No known, uncontrolled coagulopathy

Hepatic

  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • SGOT and SGPT ≤ 1.5 times ULN
  • Alkaline phosphatase ≤ 2.5 times ULN

Renal

  • Creatinine ≤ 1.5 times normal
  • Creatinine clearance > 50 mL/min

Cardiovascular

  • No clinically significant cardiac disease
  • No congestive heart failure
  • No symptomatic coronary artery disease
  • No poorly controlled cardiac arrhythmias
  • No myocardial infarction within the past year

Gastrointestinal

  • No active inflammatory bowel disease
  • No lack of physical integrity of the upper gastrointestinal tract
  • No malabsorption syndrome

Other

  • No other prior or concurrent malignancy except inactive, non-invasive carcinoma of the cervix or non-melanoma skin cancer
  • No concurrent serious, uncontrolled infection(s)
  • No prior unanticipated severe reaction to fluoropyrimidine therapy
  • No known sensitivity to fluorouracil
  • No prior uncontrolled seizures
  • No CNS disorders that would preclude study participation
  • No other medical or psychiatric condition that would preclude study participation
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 3 months after study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No prior immunotherapy for rectal cancer

Chemotherapy

  • No prior chemotherapy for rectal cancer

Endocrine therapy

  • Not specified

Radiotherapy

  • No prior radiotherapy for rectal cancer
  • No prior pelvic radiotherapy

Surgery

  • More than 4 weeks since prior major surgery and recovered
  • No prior surgery for rectal cancer

Other

  • More than 4 weeks since prior participation in another investigational drug study
  • No concurrent celecoxib
  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: NCT00084591

Locations
United States, Pennsylvania
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111-2497
Sponsors and Collaborators
Fox Chase Cancer Center
Investigators
Principal Investigator: Gary Freedman, MD Fox Chase Cancer Center
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00084591     History of Changes
Other Study ID Numbers: CDR0000365462, P30CA006927, FCCC-03606
Study First Received: June 10, 2004
Last Updated: February 11, 2010
Health Authority: United States: Federal Government

Keywords provided by Fox Chase Cancer Center:
stage II rectal cancer
stage III rectal cancer
adenocarcinoma of the rectum

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

ClinicalTrials.gov processed this record on November 24, 2014