Carcinoma of the AppendixPhase 2NCT00006112
Fluorouracil With or Without Mitomycin in Treating Patients With Peritoneal Cancer
A Phase 2 study testing chemotherapy, fluorouracil and leucovorin calcium in people with Carcinoma of the Appendix and Colorectal Cancer, run by Gustave Roussy, Cancer Campus, Grand Paris at 1 site in France.
Trial summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Randomized phase II trial to compare the effectiveness of fluorouracil with or without mitomycin in treating patients who have… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Carcinoma of the Appendix, Colorectal Cancer, Primary Peritoneal Cavity Cancer
- What is being tested?
- chemotherapy, fluorouracil and leucovorin calcium
- How many people
- Not given
- Where
- 1 siteFrance
- Study dates
- Jan 1996to not given
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
DISEASE CHARACTERISTICS: Histologically proven peritoneal cancer that is amenable to total resection Originated as colorectal adenocarcinoma or cancer of the appendix No diffuse (unresectable) tumors No microscopic cancer only No hepatic, lymph node, or extraabdominal metastases on the preoperative work-up No primitive peritoneal mesothelioma No peritoneal pseudomyxomas or ascites No cancer that originates as ovarian or neuroendocrine cancer, especially sarcomas (intra- or retroperitoneal) Complete resection of tumor deposit No originating cancer of unknown origin
PATIENT CHARACTERISTICS: Age: Not specified Performance status: Not specified Life expectancy: Not specified Hematopoietic: WBC greater than 1,500/mm3 Platelet count greater than 100,000/mm3 No chronic hematologic disorder No coagulation disorder Hepatic: Not specified Renal: Creatinine less than 1.36 mg/dL Other: No significant medical condition that would preclude study
PRIOR CONCURRENT THERAPY: See Disease Characteristics
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Therapeutic Study Comparing Tumor Resection Followed Immediately by Intraperitoneal Chemotherapy and Systemic Chemotherapy VS Systemic Chemotherapy Alone for the Treatment of Colorectal Cancer Metastatic to the Peritoneum
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Randomized phase II trial to compare the effectiveness of fluorouracil with or without mitomycin in treating patients who have peritoneal cancer.
Read the detailed description
OBJECTIVES: I. Compare the efficacy of adjuvant systemic fluorouracil with intraperitoneal mitomycin vs systemic fluorouracil alone in terms of survival in patients with peritoneal cancer originating from the colorectum.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to center and mode of surgery. Patients are randomized to one of two treatment arms. Arm I: Patients undergo complete resection of tumor on day 0. Patients then receive mitomycin intraperitoneally (IP) over 23 hours on day 1 and fluorouracil IP over 24 hours on days 2-5. Patients then receive one of three systemic chemotherapy regimens for 6 months: Regimen I: Patients receive leucovorin calcium IV over 2 hours and fluorouracil IV over 22 hours on days 1 and 2. Treatment repeats every 2 weeks. Regimen II: Patients receive fluorouracil IV continuously for 7 weeks. Treatment repeats every 8 weeks. Regimen III: Leucovorin calcium and fluorouracil are administered as per standard procedure. Arm II: Patients receive treatment as in arm I but without early intraperitoneal chemotherapy. Patients are followed every 3 months for 2 years.
PROJECTED ACCRUAL: At least 90 patients (45 per arm) will be accrued for this study.
- Being tested
- chemotherapy, fluorouracil, leucovorin calcium, mitomycin C
- Keywords
- stage IV colon cancer, stage IV rectal cancer, adenocarcinoma of the colon, adenocarcinoma of the rectum, carcinoma of the appendix, primary peritoneal cavity cancer
- Medical subject headings
- Appendiceal Neoplasms, 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.
chemotherapyDrug
fluorouracilDrug
mitomycin CDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2004 (estimated)
- Study startJan 1996
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma of the AppendixStudies 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
Sponsor and investigators
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
- Sponsor type
- University, hospital or other
- Investigators
- Dominique Elias, MD, Study chair, Gustave Roussy, Cancer Campus, Grand Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00006112
- Sponsor's protocol ID
- CDR0000068124
- Other IDs
- FRE-IGR-95/040/434-SUGAR, EU-20012
- Status last verified
- May 2001
- First submitted
- 3 Aug 2000
- Last updated
- 26 Apr 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Therapeutic Study Comparing Tumor Resection Followed Immediately by Intraperitoneal Chemotherapy and Systemic Chemotherapy VS Systemic Chemotherapy Alone for the Treatment of Colorectal Cancer Metastatic to the Peritoneum
- ClinicalTrials.gov ID
- NCT00006112
- Acronym / sponsor ID
- CDR0000068124
- Keywords
- stage IV colon cancer, stage IV rectal cancer, adenocarcinoma of the colon, adenocarcinoma of the rectum, carcinoma of the appendix, primary peritoneal cavity cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand ParisUniversity, hospital or other
- Study start
- Jan 1996
- First posted
- 4 May 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. Combining more than one drug may kill more tumor cells.
PURPOSE: Randomized phase II trial to compare the effectiveness of fluorouracil with or without mitomycin in treating patients who have peritoneal cancer.
Detailed description
OBJECTIVES: I. Compare the efficacy of adjuvant systemic fluorouracil with intraperitoneal mitomycin vs systemic fluorouracil alone in terms of survival in patients with peritoneal cancer originating from the colorectum.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to center and mode of surgery. Patients are randomized to one of two treatment arms. Arm I: Patients undergo complete resection of tumor on day 0. Patients then receive mitomycin intraperitoneally (IP) over 23 hours on day 1 and fluorouracil IP over 24 hours on days 2-5. Patients then receive one of three systemic chemotherapy regimens for 6 months: Regimen I: Patients receive leucovorin calcium IV over 2 hours and fluorouracil IV over 22 hours on days 1 and 2. Treatment repeats every 2 weeks. Regimen II: Patients receive fluorouracil IV continuously for 7 weeks. Treatment repeats every 8 weeks. Regimen III: Leucovorin calcium and fluorouracil are administered as per standard procedure. Arm II: Patients receive treatment as in arm I but without early intraperitoneal chemotherapy. Patients are followed every 3 months for 2 years.
PROJECTED ACCRUAL: At least 90 patients (45 per arm) will be accrued for this study.
Study design
- Primary purpose
- Treatment
Who may qualify
- 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 | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2011.
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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
1 site in 1 country: 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 Carcinoma of the Appendix and Colorectal Cancer, run by Gustave Roussy, Cancer Campus, Grand Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
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 26 Apr 2011.