Radiation Therapy and Chemotherapy Followed by Surgery and Combination Chemotherapy in Treating Patients With Rectal Cancer

Colorectal Cancer Clinical Trial

Official title:

Phase II Study: Hyperfractionated Pre-Op Chemo-Radiation for Locally Advanced Rectal Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00021398
• Other study ID #: CDR0000068776
• Secondary ID: P30CA006927FCCC-
• Status: Completed
• Phase: Phase 2
• Start date: July 1996
• Est. completion date: September 2018

Study information

• Verified date: June 2020
• Source: Fox Chase Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy and chemotherapy may shrink the tumor so that it can be removed during surgery.

PURPOSE: Phase II trial to study the effectiveness of radiation therapy and chemotherapy followed by surgery and combination chemotherapy in treating patients who have stage II or stage III rectal cancer.

Description:

OBJECTIVES: I. Determine the local recurrence rate, disease-free survival, and overall survival of patients with stage II or III rectal cancer treated with neoadjuvant radiotherapy and fluorouracil followed by surgical resection and adjuvant fluorouracil and leucovorin calcium. II. Determine the toxicity rate in patients treated with this regimen. III. Correlate failure-free survival with ultrasound-determined preoperative staging in patients treated with this regimen. IV. Determine the quality of life of patients treated with this regimen. V. Determine if toxicity due to treatment, daily stool frequency, sexual dysfunction, and disease-free survival correlates with quality of life parameters in patients treated with this regimen. VI. Correlate clinical selection criteria with ability to perform sphincter-sparing surgery in patients treated with this regimen. VII. Determine post-chemoradiotherapy pathological response, margin status, and lymph node status and correlate these factors with initial clinico-pathologic findings in patients treated with this regimen.

OUTLINE: Patients undergo pelvic radiotherapy once daily five days a week for 5 weeks followed by boost radiotherapy twice daily for 7 days. Patients also receive neoadjuvant fluorouracil IV continuously over days 1-4 and 36-40. Patients undergo surgical resection 4-6 weeks after completion of radiotherapy. At 4 weeks after surgery, patients receive adjuvant leucovorin calcium IV and fluorouracil IV once daily five days a week. Treatment continues every 4 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, at the completion of pelvic and boost radiotherapy, at 4 weeks after completion of chemoradiotherapy (prior to surgery), and then at 3, 6, and 12 months after completion of study therapy. Patients are followed every 3 months for 2 years, every 4 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 23-41 patients will be accrued for this study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: September 2018
• Est. primary completion date: July 2001
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

DISEASE CHARACTERISTICS:

• Histologically confirmed adenocarcinoma of the rectum

• Tumor extending through bowel wall (T3) OR

• Fixation to surrounding structures (T4) OR

• Nodal involvement by endorectal ultrasound (N1-2)

• Tumor extending through bowel wall, but not fixed (T3) must be:

• At least 4 cm or at least 40% of bowel circumference OR

• Accompanied by nodal involvement

• Evidence of transmural penetration confirmed by 2 of the following:

• CT scan

• Pelvic MRI

• Transrectal ultrasound

• Physical exam

• Proximal extent of tumor must not extend higher than 12 cm above dentate line and must be below pelvic peritoneal reflexion or sacral promontory

• Regional lymph node involvement allowed

• No distant metastases by CT scan of abdomen and pelvis or chest x-ray

PATIENT CHARACTERISTICS:

• Age: Over 18

• Performance status: ECOG 0-1

• Life expectancy: At least 2 years

• Hematopoietic:

• Leukocyte count greater than 4,000/mm3

• Platelet count at least 100,000/mm3

• Hemoglobin greater than 10 g/dL

• Hepatic:

• SGOT and SGPT less than 1.5 times normal

• Bilirubin less than 1.5 mg/dL

• Renal: Creatinine less than 1.8 mg/dL

• Other:

• Not pregnant or nursing

• Negative pregnancy test

• No other prior or concurrent malignancy within the past 5 years except inactive non-melanoma skin cancer or carcinoma in situ of the cervix

• No psychiatric condition that would preclude informed consent

• No other serious medical illness that would limit survival

PRIOR CONCURRENT THERAPY:

• Biologic therapy: Not specified

• Chemotherapy: No prior chemotherapy for rectal cancer

• Endocrine therapy: Not specified

• Radiotherapy: No prior radiotherapy for rectal cancer

• Surgery: No prior surgery for rectal cancer, except diagnostic biopsy

Related Conditions & MeSH terms

• Colorectal Cancer
• Rectal Neoplasms

Intervention

Drug:
• fluorouracil

• leucovorin calcium

Procedure:
• conventional surgery

Radiation:
• radiation therapy

Locations

Country	Name	City	State
United States	Bon Secours-Holy Family Health System	Altoona	Pennsylvania
United States	Delaware County Memorial Hospital	Drexel Hill	Pennsylvania
United States	Hunterdon Regional Cancer Center	Flemington	New Jersey
United States	Pinnacle Health Hospitals	Harrisburg	Pennsylvania
United States	Conemaugh Memorial Hospital	Johnstown	Pennsylvania
United States	Kimball Medical Center	Lakewood	New Jersey
United States	Saint Mary Regional Center	Langhorne	Pennsylvania
United States	North Penn Hospital	Lansdale	Pennsylvania
United States	Fox Chase Cancer Center at Virtua Memorial Hospital Burlington County	Mount Holly	New Jersey
United States	Paoli Memorial Hospital	Paoli	Pennsylvania
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania
United States	Pottstown Memorial Regional Cancer Center	Pottstown	Pennsylvania
United States	Reading Hospital and Medical Center	Reading	Pennsylvania
United States	Riverview Medical Center	Red Bank	New Jersey
United States	Community Medical Center	Toms River	New Jersey
United States	St. Francis Medical Center	Trenton	New Jersey
United States	Southern Chester County Medical Center	West Grove	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Fox Chase Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of toxicity		weekly during treatment
Primary	tolerated dose of preoperative hyperfractionated radiation and concurrent chemotherapy		during radiation therapy and chemotherapy