Bladder CancerPhase 2NCT00006111
Surgery Plus Combination Chemotherapy and Radiation Therapy in Treating Patients With Cancer of the Urinary Tract
A Phase 2 study testing cisplatin, fluorouracil and conventional surgery in people with Bladder Cancer and Transitional Cell Cancer of the Renal Pelvis and Ureter, run by UNICANCER at 11 sites in France.
Trial summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining surgery with chemotherapy and radiation therapy may be an effective way to treat cancer of the urinary tract. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Bladder Cancer, Transitional Cell Cancer of the Renal Pelvis and Ureter, Urethral Cancer
- What is being tested?
- cisplatin, fluorouracil and conventional surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 11 sitesFrance
- Study dates
- Apr 1999to Jun 2008
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS: Histologically confirmed stage II, III, or IV carcinoma of the urothelium infiltrating muscle Primary OR After development of a superficial tumor T2-T4b with or without lymph node involvement and no detectable metastases No epidermoid cancer or adenocarcinoma No extrapelvic lymph node involvement
PATIENT CHARACTERISTICS: Age: 18 to 70 Performance status: WHO 0-2 Life expectancy: More than 6 months Hematopoietic: WBC greater than 4,000/mm3 Platelet count greater than 100,000/mm3 Neutrophil count greater than 1,500/mm3 Hemoglobin greater than 10 g/dL Hepatic: Not specified Renal: Creatinine less than 1.5 mg/dL Other: Not pregnant Fertile patients must use effective contraception during and for 2 months after study No other prior malignancy except nonmelanomatous skin cancer or carcinoma in situ of the cervix No prior serious illness of the gastrointestinal tract (e.g., rectal bleeding or diverticulosis with complications) No contraindication to fluorouracil, cisplatin, or radiotherapy
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy except intravesicular instillations Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy Surgery: Not specified
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
France11 sites
Institut Sainte Catherine
Avignon, 84082
Centre Oscar Lambret
Lille, 59020
Centre Leon Berard
Lyon, 69373
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
Montpellier, 34298
Centre Antoine Lacassagne
Nice, 06189
C.H.U. - Hopital Gaston Doumergue
Nîmes, 30006
Centre Eugene Marquis
Rennes, 35064
Centre Rene Huguenin
Saint-Cloud, 92211
Centre Hospitalier General de Saint Nazaire
Saint-Nazaire, 44600
Institut Claudius Regaud
Toulouse, 31052
Centre Alexis Vautrin
Vandœuvre-lès-Nancy, 54511
About this study
Official title: Multicenter Study of the Quality of Life of Patients With Invasive Urothelial Cancer Treated With Conservative Surgery Followed by Cisplatin, Fluorouracil and Radiotherapy
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining surgery with chemotherapy and radiation therapy may be an effective way to treat cancer of the urinary tract.
PURPOSE: Phase II trial to study the effectiveness of combining surgery, chemotherapy and radiation therapy in treating patients who have stage II, stage III, or stage IV cancer of the urinary tract .
Read the detailed description
OBJECTIVES: I. Assess the quality of life of patients with invasive stage II, III, or IV carcinoma of the urothelium treated with conservative surgery plus cisplatin, fluorouracil, and radiotherapy. II. Determine the efficacy of this regimen, in terms of local control, in these patients. III. Determine survival of patients treated with this regimen. IV. Determine the toxic effects of this regimen in these patients.
OUTLINE: This is a multicenter study. Patients are stratified according to tumor type (T2-4a, N0, M0; potentially resectable; no contraindication to surgery vs T2-4b, N0 or N1 or pN1, M0; refused surgery or medical contraindications to surgery). (Accrual for stratum I was completed as of 10/23/2001.) Stratum I (resectable disease): Regimen A: Patients undergo radiotherapy 5 days a week for 5 weeks. Patients also receive fluorouracil IV continuously and cisplatin IV continuously on days 1-4 during weeks 1 and 4. If complete response is achieved by week 5, patients proceed to regimen B. If partial response or progression is observed, patients undergo cystectomy. If cystectomy is refused, patients proceed to regimen B. Regimen B: Patients undergo radiotherapy 5 days a week for 2 weeks. Patients also receive fluorouracil and cisplatin as in regimen A on weeks 2 and 5. (Accrual for stratum I was completed as of 10/23/2001.) Stratum II (unresectable disease): Patients undergo radiotherapy 5 days a week for 7 weeks. Patients also receive fluorouracil and cisplatin as in regimen A on weeks 1, 4, and 7. Quality of life is assessed at baseline, at 6 months, and then at 1 year. Patients are followed at 6-8 weeks, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 75 patients (35 for stratum I and 40 for stratum II) will be accrued for this study. (Accrual for stratum I was completed as of 10/23/2001.)
- Being tested
- cisplatin, fluorouracil, conventional surgery, radiation therapy
- Keywords
- stage II bladder cancer, stage III bladder cancer, stage IV bladder cancer, anterior urethral cancer, posterior urethral cancer, urethral cancer associated with invasive bladder cancer, metastatic transitional cell cancer of the renal pelvis and ureter, regional transitional cell cancer of the renal pelvis and ureter
- Medical subject headings
- Urinary Bladder Neoplasms, Urethral Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cisplatinDrug
fluorouracilDrug
conventional surgeryProcedure or surgery
radiation therapyRadiation
| Study group | Role | What they receive |
|---|---|---|
| resectable disease | Experimental | Not described Receives: Drug: cisplatin; Drug: fluorouracil; Procedure: conventional surgery; Radiation: radiation therapy |
| unresectable disease | Experimental | Not described Receives: Drug: cisplatin; Drug: fluorouracil; Radiation: radiation therapy |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2004 (estimated)
- Study startApr 1999
- Primary completionJan 2003
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- More trials run by UNICANCERThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNICANCER
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Leon Lagrange, MD, Study chair, Centre Antoine Lacassagne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00006111
- Sponsor's protocol ID
- CDR0000068123
- Other IDs
- FRE-FNCLCC-97015, EU-20009
- Status last verified
- Feb 2021
- First submitted
- 3 Aug 2000
- Last updated
- 21 Feb 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Study of the Quality of Life of Patients With Invasive Urothelial Cancer Treated With Conservative Surgery Followed by Cisplatin, Fluorouracil and Radiotherapy
- ClinicalTrials.gov ID
- NCT00006111
- Acronym / sponsor ID
- CDR0000068123
- Keywords
- stage II bladder cancer, stage III bladder cancer, stage IV bladder cancer, anterior urethral cancer, posterior urethral cancer, urethral cancer associated with invasive bladder cancer, metastatic transitional cell cancer of the renal pelvis and ureter, regional transitional cell cancer of the renal pelvis and ureter
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- UNICANCERUniversity, hospital or other
- Study start
- Apr 1999 (actual)
- Primary completion
- Jan 2003 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 3 Feb 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. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining surgery with chemotherapy and radiation therapy may be an effective way to treat cancer of the urinary tract.
PURPOSE: Phase II trial to study the effectiveness of combining surgery, chemotherapy and radiation therapy in treating patients who have stage II, stage III, or stage IV cancer of the urinary tract .
Detailed description
OBJECTIVES: I. Assess the quality of life of patients with invasive stage II, III, or IV carcinoma of the urothelium treated with conservative surgery plus cisplatin, fluorouracil, and radiotherapy. II. Determine the efficacy of this regimen, in terms of local control, in these patients. III. Determine survival of patients treated with this regimen. IV. Determine the toxic effects of this regimen in these patients.
OUTLINE: This is a multicenter study. Patients are stratified according to tumor type (T2-4a, N0, M0; potentially resectable; no contraindication to surgery vs T2-4b, N0 or N1 or pN1, M0; refused surgery or medical contraindications to surgery). (Accrual for stratum I was completed as of 10/23/2001.) Stratum I (resectable disease): Regimen A: Patients undergo radiotherapy 5 days a week for 5 weeks. Patients also receive fluorouracil IV continuously and cisplatin IV continuously on days 1-4 during weeks 1 and 4. If complete response is achieved by week 5, patients proceed to regimen B. If partial response or progression is observed, patients undergo cystectomy. If cystectomy is refused, patients proceed to regimen B. Regimen B: Patients undergo radiotherapy 5 days a week for 2 weeks. Patients also receive fluorouracil and cisplatin as in regimen A on weeks 2 and 5. (Accrual for stratum I was completed as of 10/23/2001.) Stratum II (unresectable disease): Patients undergo radiotherapy 5 days a week for 7 weeks. Patients also receive fluorouracil and cisplatin as in regimen A on weeks 1, 4, and 7. Quality of life is assessed at baseline, at 6 months, and then at 1 year. Patients are followed at 6-8 weeks, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 75 patients (35 for stratum I and 40 for stratum II) will be accrued for this study. (Accrual for stratum I was completed as of 10/23/2001.)
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| resectable disease | Experimental | Drug: cisplatin, Drug: fluorouracil, Procedure: conventional surgery, Radiation: radiation therapy |
| unresectable disease | Experimental | Drug: cisplatin, Drug: fluorouracil, Radiation: radiation therapy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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 |
|---|---|---|
| cisplatin | Drug | resectable disease, unresectable disease |
| fluorouracil | Drug | resectable disease, unresectable disease |
| conventional surgery | Procedure or surgery | resectable disease |
| radiation therapy | Radiation | resectable disease, unresectable disease |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 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.
Jean-Leon Lagrange, MD study chair
Centre Antoine Lacassagne
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing cisplatin, fluorouracil and conventional surgery in people with Bladder Cancer and Transitional Cell Cancer of the Renal Pelvis and Ureter, run by UNICANCER at 11 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 21 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 11 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.
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 21 Feb 2021.