Combination Chemotherapy and Radiation Therapy in Treating Patients With Recurrent Metastatic Colorectal Cancer
Phase II Study of Recurrent Ganglionic Colorectal Cancer Not Accessible By Surgery Treated Using Chemotherapy With Simplified FOLFOX7 Followed By Radiotherapy Combined With 5FU and Oxaliplatin
  • Phase

    Phase 2
  • Study Type

  • Status

    Completed No Results Posted
  • Study Participants

RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, fluorouracil, and leucovorin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving more than one drug (combination chemotherapy) together with radiation therapy may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving combination chemotherapy together with radiation therapy works in treating patients with recurrent metastatic colorectal cancer.


Determine the response rate in patients with recurrent metastatic colorectal cancer treated with neoadjuvant oxaliplatin, fluorouracil, and leucovorin calcium followed by radiotherapy and concurrent fluorouracil and oxaliplatin.


Determine the overall survival and disease-free survival of patients treated with this regimen.
Determine the primary site of recurrence and time to recurrence in patients treated with this regimen.
Determine quality of life of patients treated with this regimen.

OUTLINE: This is a nonrandomized, open-label, multicenter study.

Neoadjuvant chemotherapy: Patients receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1. Patients also receive fluorouracil IV continuously over 46 hours beginning day 1. Treatment repeats every 14 days for 4 courses in the absence of disease progression or unacceptable toxicity. Two to 5 weeks later, patients with stable or responding disease proceed to chemoradiotherapy.
Chemoradiotherapy: Patients receive fluorouracil IV continuously 5 days a week for 5 weeks and oxaliplatin IV over 1 hour on days 1, 8, 15, 22, and 29. Patients also undergo radiotherapy 5 days a week for 5 weeks beginning on day 1.

Quality of life is assessed at baseline, 1 week after the completion of neoadjuvant chemotherapy, on days 15, 30, and 42 of chemoradiotherapy, and at 1 and 2 months after the completion of study treatment.

After completion of study treatment, patients are followed periodically.

PROJECTED ACCRUAL: A total of 39 patients will be accrued for this study.
Study Started
Aug 31
Primary Completion
Jan 31
Last Update
Feb 09

Drug fluorouracil

Drug leucovorin calcium

Drug oxaliplatin

Procedure neoadjuvant therapy



Histologically confirmed adenocarcinoma of the colon or rectum

Metastatic disease isolated to the following lymph nodes:


Retroperitoneal, including the following sites:

Incompletely resected disease

Recurrent disease, defined by 1 of the following criteria:

Progression occurred within 6 months after prior oxaliplatin or after the patient received no prior oxaliplatin
Progressive disease after cisplatin or fluorouracil
Must be able to be encompassed in radiation field


ECOG performance status (PS) 0-2 or Karnofsky PS 60-100%
Life expectancy more than 12 weeks
Absolute neutrophil count ≥ 1,500/mm^3
Platelet count ≥ 100,000 /mm^3
Alkaline phosphatase ≤ 5 times normal
Bilirubin ≤ 2 times normal
Creatinine < 2 times normal or creatinine clearance ≥ 40 mL/min
No peripheral neuropathy > grade 1
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No weight loss > 15% since diagnosis of recurrent disease
No uncontrolled heart disease
No angina
No symptomatic disease of the inferior artery
No psychological, familial, sociological, or geographical condition that would preclude study treatment or compliance


See Disease Characteristics
No prior chemotherapy or radiotherapy
No concurrent corticosteroids
No Results Posted