Know Cancer

or
forgot password

Phase I Study of Preoperative Intensity Modulated Radiation Therapy (IMRT) With Incorporated Boost and Oral Capecitabine in Locally Advanced Rectal Cancer


Phase 1
18 Years
N/A
Not Enrolling
Both
Colorectal Cancer

Thank you

Trial Information

Phase I Study of Preoperative Intensity Modulated Radiation Therapy (IMRT) With Incorporated Boost and Oral Capecitabine in Locally Advanced Rectal Cancer


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Outcome Measure:

Acute toxicity by CTCAE at 6 weeks following study completion

Safety Issue:

Yes

Principal Investigator

Gary Freedman, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fox Chase Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000365462

NCT ID:

NCT00084591

Start Date:

December 2003

Completion Date:

February 2007

Related Keywords:

  • Colorectal Cancer
  • stage II rectal cancer
  • stage III rectal cancer
  • adenocarcinoma of the rectum
  • Rectal Neoplasms
  • Colorectal Neoplasms

Name

Location

Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111