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

NCT00021398 | Completed Phase 2

• 4 other identifiers: CDR0000068776P30CA006927FCCC-96071NCI-G01-1988
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 17

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.

Conditions

Colorectal Cancer

Keywords

stage II rectal cancer; stage III rectal cancer; adenocarcinoma of the rectum

Outcome Measures

Primary Outcomes (2)

• Frequency of toxicity

  weekly during treatment

• tolerated dose of preoperative hyperfractionated radiation and concurrent chemotherapy

  during radiation therapy and chemotherapy

Study Arms (1)

Radiation Therapy, Chemotherapy and Surgery

EXPERIMENTAL

Drug: fluorouracil; Drug: leucovorin calcium; Procedure: conventional surgery; Radiation: radiation therapy

Interventions

fluorouracil DRUG

Radiation Therapy, Chemotherapy and Surgery

leucovorin calcium DRUG

Radiation Therapy, Chemotherapy and Surgery

conventional surgery PROCEDURE

Radiation Therapy, Chemotherapy and Surgery

radiation therapy RADIATION

Radiation Therapy, Chemotherapy and Surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Fox Chase Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (17)

Hunterdon Regional Cancer Center

Flemington, New Jersey, 08822, United States

Location

Kimball Medical Center

Lakewood, New Jersey, 08701, United States

Location

Fox Chase Cancer Center at Virtua Memorial Hospital Burlington County

Mount Holly, New Jersey, 08060, United States

Location

Riverview Medical Center

Red Bank, New Jersey, 07701, United States

Location

Community Medical Center

Toms River, New Jersey, 08755, United States

Location

St. Francis Medical Center

Trenton, New Jersey, 08629, United States

Location

Bon Secours-Holy Family Health System

Altoona, Pennsylvania, 16602, United States

Location

Delaware County Memorial Hospital

Drexel Hill, Pennsylvania, 19026, United States

Location

Pinnacle Health Hospitals

Harrisburg, Pennsylvania, 17105-8700, United States

Location

Conemaugh Memorial Hospital

Johnstown, Pennsylvania, 15905, United States

Location

Saint Mary Regional Center

Langhorne, Pennsylvania, 19047, United States

Location

North Penn Hospital

Lansdale, Pennsylvania, 19446, United States

Location

Paoli Memorial Hospital

Paoli, Pennsylvania, 19301-1792, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

Pottstown Memorial Regional Cancer Center

Pottstown, Pennsylvania, 19464, United States

Location

Reading Hospital and Medical Center

Reading, Pennsylvania, 19612-6052, United States

Location

Southern Chester County Medical Center

West Grove, Pennsylvania, 19390, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Rectal Neoplasms

Interventions

Fluorouracil; Leucovorin; Radiotherapy

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes; Therapeutics

Study Officials

• Joshua Meyer, MD

  Fox Chase Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2001
• First Posted: April 13, 2004
• Study Start: July 1, 1996
• Primary Completion: July 1, 2001
• Study Completion: September 1, 2018
• Last Updated: June 5, 2020

Record last verified: 2020-06

Locations

US (17)