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Colorectal CancerPhase 2NCT00268333

Combination Chemotherapy and Radiation Therapy in Treating Patients With Recurrent Metastatic Colorectal Cancer

A Phase 2 study testing fluorouracil, leucovorin calcium and oxaliplatin in people with Colorectal Cancer, run by GERCOR - Multidisciplinary Oncology Cooperative Group at 9 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Colorectal Cancer
What is being tested?
fluorouracil, leucovorin calcium and oxaliplatin
Type of treatment
Surgery or procedure
How many people
39 participants
Where
9 sitesFrance
Study dates
Aug 2005to Jan 2006
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

  • 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

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No prior chemotherapy or radiotherapy
  • No concurrent corticosteroids

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

France9 sites

  • Institut Sainte Catherine

    Avignon, 84082

  • Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz

    Besançon, 25030

  • Hopital Drevon

    Dijon, 21000

  • Hopital Robert Boulin

    Libourne, 33500

  • Polyclinique des Quatre Pavillons

    Lormont, 33310

  • Hopital Europeen Georges Pompidou

    Paris, 75015

  • Hopital Tenon

    Paris, 75970

  • Polyclinique De Courlancy

    Reims, F-51100

  • C.H. Senlis

    Senlis, 60309

Other trials in France

About this study

Official title: 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

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.

Read the detailed description

OBJECTIVES:

Primary

  • 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.

Secondary

  • 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.

Keywords
adenocarcinoma of the colon, adenocarcinoma of the rectum, stage IV colon cancer, stage III colon cancer, stage III rectal cancer, stage IV rectal cancer
Medical subject headings
Colorectal Neoplasms, Colonic Neoplasms, Rectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Response rate

Secondary outcomes (5)

  1. Overall survival

  2. Disease-free survival

  3. Primary site of recurrence

  4. Time to recurrence

  5. Quality of life

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Dec 2005 (estimated)
  2. Study startAug 2005
  3. Primary completionJan 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Masking
None (open label)
Enrolment
39 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00268333
Sponsor's protocol ID
CDR0000453784
Other IDs
GERCOR-C04-1, EU-20568, SANOFI-GERCOR-C04-1
Status last verified
May 2007
First submitted
20 Dec 2005
Last updated
9 Feb 2009
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing fluorouracil, leucovorin calcium and oxaliplatin in people with Colorectal Cancer, run by GERCOR - Multidisciplinary Oncology Cooperative Group at 9 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Response rate. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00268333.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2009.

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