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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 2
18 Years
80 Years
Not Enrolling
Colorectal Cancer

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Trial Information

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



- 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

- 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.

Inclusion Criteria


- Histologically confirmed adenocarcinoma of the colon or rectum

- Metastatic disease isolated to the following lymph nodes:

- Aortic

- Interaortic

- Celiomesenteric

- Retroperitoneal, including the following sites:

- Peri-uretal

- Liver

- Iliac

- Clavicle

- Mediastinum

- Inguinal

- Cervical

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate

Safety Issue:


Principal Investigator

Laurent Mineur, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Institut Sainte Catherine


United States: Federal Government

Study ID:




Start Date:

August 2005

Completion Date:

Related Keywords:

  • Colorectal Cancer
  • adenocarcinoma of the colon
  • adenocarcinoma of the rectum
  • stage IV colon cancer
  • stage III colon cancer
  • stage III rectal cancer
  • stage IV rectal cancer
  • Colorectal Neoplasms