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

NCT ID: NCT00021398

Last Updated: 2020-06-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1996-07-31
• Study Completion Date: 2018-09-30

Brief 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.

Detailed 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.

Conditions

Colorectal Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Radiation Therapy, Chemotherapy and Surgery

Group Type: EXPERIMENTAL

fluorouracil

Intervention Type: DRUG

leucovorin calcium

Intervention Type: DRUG

conventional surgery

Intervention Type: PROCEDURE

radiation therapy

Intervention Type: RADIATION

Interventions

fluorouracil

Intervention Type: DRUG

leucovorin calcium

Intervention Type: DRUG

conventional surgery

Intervention Type: PROCEDURE

radiation therapy

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Fox Chase Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joshua Meyer, MD

Role: PRINCIPAL_INVESTIGATOR

Fox Chase Cancer Center

Locations

Hunterdon Regional Cancer Center

Flemington, New Jersey, United States

Kimball Medical Center

Lakewood, New Jersey, United States

Fox Chase Cancer Center at Virtua Memorial Hospital Burlington County

Mount Holly, New Jersey, 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

Bon Secours-Holy Family Health System

Altoona, Pennsylvania, United States

Delaware County Memorial Hospital

Drexel Hill, Pennsylvania, United States

Pinnacle Health Hospitals

Harrisburg, Pennsylvania, United States

Conemaugh Memorial Hospital

Johnstown, Pennsylvania, United States

Saint Mary Regional Center

Langhorne, Pennsylvania, United States

North Penn Hospital

Lansdale, Pennsylvania, 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

Southern Chester County Medical Center

West Grove, Pennsylvania, United States

Countries

United States

Other Identifiers

P30CA006927

Identifier Type: NIH

Identifier Source: secondary_id

View Link

FCCC-96071

Identifier Type: -

Identifier Source: secondary_id

NCI-G01-1988

Identifier Type: -

Identifier Source: secondary_id

CDR0000068776

Identifier Type: -

Identifier Source: org_study_id