Anal CancerPhase 2/3NCT00068744
Radiation Therapy, Mitomycin, and Either Fluorouracil or Cisplatin in Treating Patients With Locally Advanced Anal Cancer
A Phase 2/3 study testing cisplatin, fluorouracil and mitomycin C in people with Anal Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC at 24 sites in 7 countries.
Trial summary
RATIONALE: Drugs used in chemotherapy, such as mitomycin, fluorouracil, and cisplatin, use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy may kill more tumor cells. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Anal Cancer
- What is being tested?
- cisplatin, fluorouracil and mitomycin C
- Type of treatment
- Surgery or procedure
- How many people
- 88 participants
- Where
- 24 sitesin 7 countries
- Study dates
- Jul 2003to Nov 2007
- Phase
- Phase 2/3
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed squamous cell anal carcinoma
- Keratinizing or non-keratinizing
- The following stages are eligible:
- T2, N0, M0 with maximum tumor diameter at least 4 cm
- T3-T4, N0, M0
- Any T, N1-N3, M0
- Tumor located in the anal canal OR in the anal margin and infiltrating the anal canal
- No primary adenocarcinoma of the anus
- Measurable disease
PATIENT CHARACTERISTICS:
Age
- 18 to 75
Performance status
- WHO 0-1
Life expectancy
- Not specified
Hematopoietic
- Granulocyte count greater than 2,000/mm^3
- Platelet count greater than 100,000/mm^3
Hepatic
- Not specified
Renal
- Creatinine less than 1.4 mg/dL
Cardiovascular
- No grade I angina pectoris with clinical symptoms within the past 3 months
- No grade II-IV angina pectoris within the past 3 months
- No stage II or greater distal arteritis
Other
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No other prior malignancy except adequately treated basal cell skin cancer or carcinoma in situ of the cervix
- No psychological, familial, sociological, or geographical condition that would preclude study compliance and follow-up
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- No other concurrent chemotherapy
Endocrine therapy
- Not specified
Radiotherapy
- No other concurrent radiotherapy
Surgery
- No prior colostomy
Other
- No prior treatment for anal cancer
Trial locations and contacts
24 sites in 7 countries.
24 sites in 7 countries
Belgium8 sites
Ziekenhuis Netwerk Antwerpen Middelheim
Antwerp, B-2020
Institut Jules Bordet
Brussels, 1000
Centre Hospitalier Lyon Sud
Brussels, 1200
Cliniques Universitaires Saint-Luc
Brussels, 1200
Universitair Ziekenhuis Antwerpen
Edegem, B-2650
Cazk Groeninghe - Campus Maria's Voorzienigheid
Kortrijk, B-8500
U.Z. Gasthuisberg
Leuven, B-3000
Algemeen Ziekenhuis Sint-Augustinus
Wilrijk, 2610
Germany7 sites
Urologische Klinik - Universitaetsklinikum Aachen
Aachen, D-52074
Charite - Campus Charite Mitte
Berlin, D-10117
Robert Roessle Comprehensive Cancer Center - Charite Campus Buch
Berlin, D-13122
Universitaetsklinikum Essen
Essen, D-45122
Universitaetsklinikum Halle
Halle, D-06097
Onkologische Schwerpunktpraxis - Leer
Leer, D-26789
Universitaetsklinikum Tuebingen
Tübingen, D-72076
France3 sites
Institut Sainte Catherine
Avignon, 84082
Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz
Besançon, 25030
Centre de Lutte Contre le Cancer Georges-Francois Leclerc
Dijon, 21079
Italy2 sites
Ospedale Sant Anna
Como, 22100
Ospedale Busonera - Divisione Oncologia Medica
Padova, 35128
Netherlands2 sites
Arnhems Radiotherapeutisch Instituut
Arnhem, 6815 AD
Dr. Bernard Verbeeten Instituut
Tilburg, 5042 SB
About this study
Official title: Continuous Fluorouracil Plus Mitomycin C Versus Mitomycin C Plus Cisplatin As Chemotherapy Combination In Combined Radiochemotherapy For Locally Advanced Anal Cancer. A Phase II-III Study
RATIONALE: Drugs used in chemotherapy, such as mitomycin, fluorouracil, and cisplatin, use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy may kill more tumor cells. It is not yet known whether radiation therapy and mitomycin are more effective when combined with fluorouracil or with cisplatin in treating anal cancer .
PURPOSE: This randomized phase II/III trial is studying how well giving radiation therapy and mitomycin together with fluorouracil works compared to radiation therapy, mitomycin, and cisplatin in treating patients with locally advanced anal cancer.
Read the detailed description
OBJECTIVES:
Phase II
- Primary
- Compare the early clinical response (tumor response at 8 weeks) of patients with locally advanced anal cancer treated with radiotherapy with mitomycin and cisplatin vs mitomycin and fluorouracil.
- Secondary
- Compare the feasibility of these regimens in these patients.
- Compare the acute toxicity of these regimens in these patients.
- Compare patient compliance to these regimens.
Phase III
- Primary
- Compare the event-free survival of patients treated with these regimens.
- Secondary
- Compare colostomy-free, disease-free, and overall survival of patients treated with these regimens.
- Compare locoregional control in patients treated with these regimens.
- Compare the late toxicity of these regimens in these patients.
- Compare quality of life of patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, T stage (T2 vs T3 vs T4), and nodal status (N0 vs N+). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients undergo radiotherapy once daily 5 days a week on weeks 1-4, 7-8, and 3 days of week 9 (total of 33 fractions). Patients concurrently receive fluorouracil IV continuously on days 1-26 and 43-59 and mitomycin IV over 15 minutes on days 1 and 43.
- Arm II: Patients receive radiotherapy and mitomycin as in arm I and cisplatin IV over 1 hour on days 1, 8, 15, 22, 43, 50, and 57.
In both arms, treatment continues in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, at weeks 12 and 26, and then every 6 months for 2 years.
Patients are followed every 2 weeks for 8 weeks, at week 26, and then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 678 patients (80 [40 per treatment arm] for phase II and 598 [299 per treatment arm] for phase III) will be accrued for this study within 2-5 years.
- Conditions
- Anal Cancer
- Being tested
- cisplatin, fluorouracil, mitomycin C, radiation therapy
- Keywords
- squamous cell carcinoma of the anus, stage II anal cancer, stage IIIA anal cancer, stage IIIB anal cancer
- Medical subject headings
- Anus Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cisplatinDrug
fluorouracilDrug
mitomycin CDrug
radiation therapyRadiation
What is being measured
The primary outcome is the main question the study is designed to answer.
Response as measured by RECIST at 8 weeks after completion of study treatment (Phase II)
Event-free survival as measured by Logrank at 12 and 26 weeks, then every 6 months thereafter (Phase III)
Secondary outcomes (7)
Acute toxicity and compliance to treatment as measured by CTC v 2.0 at completion of study treatment (Phase II)
Colostomy-free survival as measured by Logrank at 12 and 26 weeks, then every 6 months thereafter (Phase III)
Overall survival as measured by Logrank at 12 and 26 weeks, then every 6 months thereafter
Disease-free survival as measured by Logrank at 12 and 26 weeks, then every 6 months thereafter
Local control as measured by Gray at 12 and 26 weeks, then every 6 months thereafter
Late toxicity as measured by RTOG and EROTC every 6 months after week 26
Quality of life as measured by EORTC Quality of Life Questionnaire-C30 and ASCT at 12 and 26 weeks, then every 6 months for 2 years after entry
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2003 (estimated)
- Study startJul 2003
- Primary completionNov 2007
Why it stopped: low accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anal CancerStudies of the same condition, open and under way.
- More trials run by European Organisation for Research and Treatment of Cancer - EORTCThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Jean-Francois Bosset, MD, Study chair, Hopital Jean Minjoz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00068744
- Sponsor's protocol ID
- EORTC-22011-40014
- Other IDs
- EORTC-22011, EORTC-40014
- Status last verified
- Sep 2012
- First submitted
- 10 Sep 2003
- Last updated
- 24 Sep 2012
- Results posted
- No
Publications
Matzinger O, Roelofsen F, Mineur L, Koswig S, Van Der Steen-Banasik EM, Van Houtte P, Haustermans K, Radosevic-Jelic L, Mueller RP, Maingon P, Collette L, Bosset JF; EORTC Radiation Oncology and Gastrointestinal Tract Cancer Groups. Mitomycin C with continuous fluorouracil or with cisplatin in combination with radiotherapy for locally advanced anal cancer (European Organisation for Research and Treatment of Cancer phase II study 22011-40014). Eur J Cancer. 2009 Nov;45(16):2782-91. doi: 10.1016/j.ejca.2009.06.020. Epub 2009 Jul 28.
PubMed 19643599
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Fluorouracil Plus Mitomycin C Versus Mitomycin C Plus Cisplatin As Chemotherapy Combination In Combined Radiochemotherapy For Locally Advanced Anal Cancer. A Phase II-III Study
- ClinicalTrials.gov ID
- NCT00068744
- Acronym / sponsor ID
- EORTC-22011-40014
- Conditions
- Anal Cancer
- Keywords
- squamous cell carcinoma of the anus, stage II anal cancer, stage IIIA anal cancer, stage IIIB anal cancer
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: low accrual
- Enrolment
- 88 participants (actual)
- Lead sponsor
- European Organisation for Research and Treatment of Cancer - EORTCResearch network
- Study start
- Jul 2003
- Primary completion
- Nov 2007 (actual)
- First posted
- 11 Sep 2003 (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, such as mitomycin, fluorouracil, and cisplatin, use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy may kill more tumor cells. It is not yet known whether radiation therapy and mitomycin are more effective when combined with fluorouracil or with cisplatin in treating anal cancer .
PURPOSE: This randomized phase II/III trial is studying how well giving radiation therapy and mitomycin together with fluorouracil works compared to radiation therapy, mitomycin, and cisplatin in treating patients with locally advanced anal cancer.
Detailed description
OBJECTIVES:
Phase II
- Primary
- Compare the early clinical response (tumor response at 8 weeks) of patients with locally advanced anal cancer treated with radiotherapy with mitomycin and cisplatin vs mitomycin and fluorouracil.
- Secondary
- Compare the feasibility of these regimens in these patients.
- Compare the acute toxicity of these regimens in these patients.
- Compare patient compliance to these regimens.
Phase III
- Primary
- Compare the event-free survival of patients treated with these regimens.
- Secondary
- Compare colostomy-free, disease-free, and overall survival of patients treated with these regimens.
- Compare locoregional control in patients treated with these regimens.
- Compare the late toxicity of these regimens in these patients.
- Compare quality of life of patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, T stage (T2 vs T3 vs T4), and nodal status (N0 vs N+). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients undergo radiotherapy once daily 5 days a week on weeks 1-4, 7-8, and 3 days of week 9 (total of 33 fractions). Patients concurrently receive fluorouracil IV continuously on days 1-26 and 43-59 and mitomycin IV over 15 minutes on days 1 and 43.
- Arm II: Patients receive radiotherapy and mitomycin as in arm I and cisplatin IV over 1 hour on days 1, 8, 15, 22, 43, 50, and 57.
In both arms, treatment continues in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, at weeks 12 and 26, and then every 6 months for 2 years.
Patients are followed every 2 weeks for 8 weeks, at week 26, and then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 678 patients (80 [40 per treatment arm] for phase II and 598 [299 per treatment arm] for phase III) will be accrued for this study within 2-5 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
Who may qualify
- Ages
- 18 to 75 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 | – |
| fluorouracil | Drug | – |
| mitomycin C | Drug | – |
| radiation therapy | Radiation | – |
Primary outcome
Response as measured by RECIST at 8 weeks after completion of study treatment (Phase II)
Event-free survival as measured by Logrank at 12 and 26 weeks, then every 6 months thereafter (Phase III)
7 secondary outcomes
Acute toxicity and compliance to treatment as measured by CTC v 2.0 at completion of study treatment (Phase II)
Colostomy-free survival as measured by Logrank at 12 and 26 weeks, then every 6 months thereafter (Phase III)
Overall survival as measured by Logrank at 12 and 26 weeks, then every 6 months thereafter
Disease-free survival as measured by Logrank at 12 and 26 weeks, then every 6 months thereafter
Local control as measured by Gray at 12 and 26 weeks, then every 6 months thereafter
Late toxicity as measured by RTOG and EROTC every 6 months after week 26
Quality of life as measured by EORTC Quality of Life Questionnaire-C30 and ASCT at 12 and 26 weeks, then every 6 months for 2 years after entry
Results and safety
The study was stopped early (reason given: low accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2012.
- Results publication: PubMed 19643599Matzinger O, Roelofsen F, Mineur L, Koswig S, Van Der Steen-Banasik EM, Van Houtte P, Haustermans K, Radosevic-Jelic L, Mueller RP, Maingon P, Collette L, Bosset JF; EORTC Radiation Oncology and Gastrointestinal Tract Cancer Groups. Mitomycin C with continuous fluorouracil or with cisplatin in combination with radiotherapy for locally advanced anal cancer (European Organisation for Research and Treatment of Cancer phase II study 22011-40014). Eur J Cancer. 2009 Nov;45(16):2782-91. doi: 10.1016/j.ejca.2009.06.020. Epub 2009 Jul 28.
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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-Francois Bosset, MD study chair
Hopital Jean Minjoz
24 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing cisplatin, fluorouracil and mitomycin C in people with Anal Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC at 24 sites in 7 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 24 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in Belgium, Germany, France, Italy, Netherlands and 2 more countries. 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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: low accrual). 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.
What does the primary outcome measure?
Response as measured by RECIST at 8 weeks after completion of study treatment (Phase II). The study lists 2 primary outcomes in all. 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 NCT00068744, which also lists 1 linked publication.
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 24 Sep 2012.