Colorectal CancerPhase 2NCT00005944
Second-look Surgery With or Without Intraperitoneal Chemotherapy in Treating Patients With Recurrent Colorectal Cancer
A Phase 2 study testing chemotherapy, fluorouracil and leucovorin calcium in people with Colorectal Cancer and Metastatic Cancer, run by UNICANCER at 18 sites in 2 countries.
Trial summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving chemotherapy drugs in different ways may kill more tumor cells. Read more about this study
- Who is it for?
- Ages 0 to 70 years
- Conditions the study is for
- Colorectal Cancer, Metastatic Cancer, Primary Peritoneal Cavity Cancer
- What is being tested?
- chemotherapy, fluorouracil and leucovorin calcium
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 18 sitesin 2 countries
- Study dates
- 1 Jul 1999to 1 Oct 2003
- 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 0 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
DISEASE CHARACTERISTICS: Primary diagnosis of adenocarcinoma of the colon or rectum and meeting one of the following risk criteria during the primary surgery: Perforated bowel (spontaneous or not) Occlusion Peritoneal deposits Invasion of serosa of more than 4 cm diameter Concurrent ovarian metastases Randomization eligibility: Presence of proven recurrent peritoneal disease (only one micronodule of 1 mm sufficient) at second look laparotomy Total resection of macroscopic lesions possible (local recurrence, lymph node or hepatic metastases)
PATIENT CHARACTERISTICS: Age: 70 and under Performance status: Not specified Life expectancy: Not specified Hematopoietic: WBC at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Not specified Renal: Creatinine no greater than 1.4 mg/dL Cardiovascular: No cardiac condition that would increase surgical risk Pulmonary: No pulmonary condition that would increase surgical risk Other: No other condition that would increase surgical risk No other malignancy within the past 5 years except basal cell skin cancer
PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent immunotherapy Chemotherapy: No other concurrent chemotherapy Endocrine therapy: No concurrent hormonal therapy Radiotherapy: No concurrent anticancer radiotherapy Surgery: See Disease Characteristics
Trial locations and contacts
18 sites in 2 countries.
18 sites in 2 countries
France17 sites
CHR de Besancon - Hopital Jean Minjoz
Besançon, 25030
Institut Bergonie
Bordeaux, 33076
CHU Ambroise Pare
Boulogne-Billancourt, F-92104
Centre Hospitalier Universitaire de Dijon
Dijon, 21033
Centre Hospitalier Regional de Lille
Lille, 59037
Centre Leon Berard
Lyon, 69373
Institut J. Paoli and I. Calmettes
Marseille, 13273
CHU de la Timone
Marseille, 13385
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
Montpellier, 34298
CHR Hotel Dieu
Nantes, 44093
CRLCC Nantes - Atlantique
Nantes-Saint Herblain, 44805
Hopital L'Archet - 2
Nice, F-06202
C.H.R. de Nimes - Hopital Caremeau
Nîmes, 30000
CHR D'Orleans - Hopital de la Source
Orléans, 45067
Centre Hospitalier Universitaire
Reims, 51092
Centre Paul Strauss
Strasbourg, 67085
Institut Gustave Roussy
Villejuif, F-94805
About this study
Official title: Study of Second Look Surgery With or Without Chemotherapy Intraperitoneally, in the Event of Risk of Intraperitoneal Recurrence
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving chemotherapy drugs in different ways may kill more tumor cells.
PURPOSE: Randomized phase II trial to compare the effectiveness of second-look surgery with or without intraperitoneal infusions of mitomycin and fluorouracil in treating patients who have colorectal cancer that is recurrent to the peritoneum.
Read the detailed description
OBJECTIVES: I. Compare the effect of second look surgery with or without intraperitoneal mitomycin and fluorouracil on the 3 year survival rate of patients with colorectal cancer who are at high risk for peritoneal cavity cancer. II. Compare the quality of life of patients treated with these regimens. III. Compare the toxicity of these regimens in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to center, risk group, presence of symptoms (yes vs no), and isolated disease (yes vs no). After primary surgery, all patients receive 6 months of chemotherapy consisting of leucovorin calcium IV followed by fluorouracil IV over 10 minutes on days 1-5 every 4 weeks. Patients then undergo second look surgery or laparoscopy at 8-12 months. Second look surgery or laparoscopy may be performed earlier if markers increase progressively for unknown reasons or symptoms of peritoneal cancer occur. Patients with recurrent disease that can be resected are randomized to one of two treatment arms. Patients with no residual disease or with unresectable disease are followed for survival. Arm I: Patients undergo complete resection of all detectable lesions followed immediately by intraperitoneal (IP) mitomycin on day 0 and fluorouracil IP on days 1-4. Patients also receive systemic chemotherapy consisting of leucovorin calcium IV over 2 hours and fluorouracil IV bolus, followed by fluorouracil IV over 22 hours on days 1 and 2. Systemic chemotherapy repeats every 2 weeks for 6 months. Arm II: Patients undergo complete or partial resection and then receive systemic chemotherapy as in arm I. Quality of life is assessed at baseline and then every 4 months for 3 years. All patients (including nonrandomized patients) are followed every 4 months for 3 years.
PROJECTED ACCRUAL: A total of 152 patients (76 randomized) will be accrued for this study.
- Being tested
- chemotherapy, fluorouracil, leucovorin calcium, mitomycin C, conventional surgery
- Keywords
- recurrent colon cancer, recurrent rectal cancer, adenocarcinoma of the colon, adenocarcinoma of the rectum, liver metastases, primary peritoneal cavity cancer
- Medical subject headings
- Colorectal Neoplasms, Neoplasm Metastasis, Colonic Neoplasms, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chemotherapyDrug
fluorouracilDrug
mitomycin CDrug
conventional surgeryProcedure or surgery
laparoscopic surgeryProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2004 (estimated)
- Study start1 Jul 1999
- Primary completion24 Oct 2000
- Study completion1 Oct 2003
Why it stopped: insuffisient recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
Sponsor and investigators
- Lead sponsor
- UNICANCER
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dominique Elias, MD, Study chair, Gustave Roussy, Cancer Campus, Grand Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005944
- Sponsor's protocol ID
- CDR0000067833
- Other IDs
- FRE-FNCLCC-97018, EU-20010
- Status last verified
- Feb 2021
- First submitted
- 5 Jul 2000
- Last updated
- 17 Feb 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Second Look Surgery With or Without Chemotherapy Intraperitoneally, in the Event of Risk of Intraperitoneal Recurrence
- ClinicalTrials.gov ID
- NCT00005944
- Acronym / sponsor ID
- CDR0000067833
- Keywords
- recurrent colon cancer, recurrent rectal cancer, adenocarcinoma of the colon, adenocarcinoma of the rectum, liver metastases, primary peritoneal cavity cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: insuffisient recruitment
- Lead sponsor
- UNICANCERUniversity, hospital or other
- Study start
- 1 Jul 1999 (actual)
- Primary completion
- 24 Oct 2000 (actual)
- Study completion
- 1 Oct 2003 (actual)
- First posted
- 24 Mar 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving chemotherapy drugs in different ways may kill more tumor cells.
PURPOSE: Randomized phase II trial to compare the effectiveness of second-look surgery with or without intraperitoneal infusions of mitomycin and fluorouracil in treating patients who have colorectal cancer that is recurrent to the peritoneum.
Detailed description
OBJECTIVES: I. Compare the effect of second look surgery with or without intraperitoneal mitomycin and fluorouracil on the 3 year survival rate of patients with colorectal cancer who are at high risk for peritoneal cavity cancer. II. Compare the quality of life of patients treated with these regimens. III. Compare the toxicity of these regimens in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to center, risk group, presence of symptoms (yes vs no), and isolated disease (yes vs no). After primary surgery, all patients receive 6 months of chemotherapy consisting of leucovorin calcium IV followed by fluorouracil IV over 10 minutes on days 1-5 every 4 weeks. Patients then undergo second look surgery or laparoscopy at 8-12 months. Second look surgery or laparoscopy may be performed earlier if markers increase progressively for unknown reasons or symptoms of peritoneal cancer occur. Patients with recurrent disease that can be resected are randomized to one of two treatment arms. Patients with no residual disease or with unresectable disease are followed for survival. Arm I: Patients undergo complete resection of all detectable lesions followed immediately by intraperitoneal (IP) mitomycin on day 0 and fluorouracil IP on days 1-4. Patients also receive systemic chemotherapy consisting of leucovorin calcium IV over 2 hours and fluorouracil IV bolus, followed by fluorouracil IV over 22 hours on days 1 and 2. Systemic chemotherapy repeats every 2 weeks for 6 months. Arm II: Patients undergo complete or partial resection and then receive systemic chemotherapy as in arm I. Quality of life is assessed at baseline and then every 4 months for 3 years. All patients (including nonrandomized patients) are followed every 4 months for 3 years.
PROJECTED ACCRUAL: A total of 152 patients (76 randomized) will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
Who may qualify
- Ages
- 0 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| chemotherapy | Drug | – |
| fluorouracil | Drug | – |
| leucovorin calcium | Drug | – |
| mitomycin C | Drug | – |
| conventional surgery | Procedure or surgery | – |
| laparoscopic surgery | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: insuffisient recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dominique Elias, MD study chair
Gustave Roussy, Cancer Campus, Grand Paris
18 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing chemotherapy, fluorouracil and leucovorin calcium in people with Colorectal Cancer and Metastatic Cancer, run by UNICANCER at 18 sites in 2 countries.
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: stopped early, as of the sponsor's last update on 17 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in France, Belgium. 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 was stopped early (reason given: insuffisient recruitment). Results are not available in the source record.
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.
Where can I read the original study information?
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 17 Feb 2021.