Rectal CancerPhase 3UFT RT Phase 3NCT00207831
Trial Testing Ftorafur (UFT) Associated With Neoadjuvant Radiotherapy Versus Radiotherapy Alone in Rectal Adenocarcinoma
A Phase 3 study testing Tegafur and Uracil in people with Rectal Cancer and Stage II/III, run by Institut Cancerologie de l'Ouest at 27 sites in France.
Trial summary
RATIONALE: Drugs used in chemotherapy, such as 5-fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing and also as a radiosensibilisant. 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
- Rectal Cancer, Stage II/III, T3 or T4 (Only Anal Extension) Rectal Cancer
- What is being tested?
- Tegafur and Uracil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 219 participants
- Where
- 27 sitesFrance
- Study dates
- Jul 2004to Feb 2008
- Phase
- Phase 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed invasive adenocarcinoma of the rectum , M0, lower side < 10 cm from anal verge
- T3 or T4 disease (T4 exclusive anal extension )
PATIENT CHARACTERISTICS:
Performance status
- ECOG 0-2 OR
- Zubrod 0-2
Life expectancy
- Not specified
Hematopoietic
- Absolute neutrophil count > 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
Hepatic
- Bilirubin < x2 UNL
Renal
- Creatinine < 150 µMol/L
Gastrointestinal
- No history of inflammatory bowel disease
- No history of difficulty or inability to take or absorb oral medications
Neurologic
- Not specified
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No other malignancy within the past 5 years except curatively treated basal cell skin cancer or carcinoma in situ of the cervix
- No history of psychiatric conditions or diminished mental capacity that would preclude study compliance or giving informed consent
PRIOR CONCURRENT THERAPY:
Chemotherapy
- No prior chemotherapy
Radiotherapy
- No prior radiotherapy to the pelvis
Other
- No other concurrent investigational drugs
- No other concurrent anticancer treatment
Trial locations and contacts
27 sites in 1 country.
27 sites in 1 country
France27 sites
Clinique Sainte Catherine
Avignon, 84000
Hopital Avicenne
Bobigny, 93
Institut de Cancérologie et d'Hématologie
Brest, 29609
Centre Hospitalier
Brive-la-Gaillarde, 19312
Centre d'Oncologie-radiothérapie d'Eure et Loir
Chartres, 28006
Centre Jean Perrin
Clermont-Ferrand, 63011
Centre Médical République
Clermont-Ferrand, 63023
Clinique du Mail
Grenoble, 38100
Centre Hospitalier Départemental
La Roche-sur-Yon, 85025
Centre Guillaume le Conquérant
Le Havre, 76600
Centre Oscar Lambret
Lille, 59020
Centre Hospitalier
Lorient, 56322
Centre léon Bérard
Lyon, 69373
Centre Gray
Maubeuge, 59600
Clinique du Pont de Chaume
Montauban, 82017
Polyclinique St Roch
Montpellier, 34967
Clinique Valdegour
Nîmes, 30900
Centre Hospitalier
Niort, 79021
Centre Hospitalier Universitaire
Poitiers, 86021
Centre Hospitalier de Cornouaille
Quimper, 29000
Centre Eugène Marquis
Rennes, 35042
Centre Hospitalier
Rodez, 12027
Centre Frédéric Joliot
Rouen, 76000
Clinique Armoricaine de Radiologie
Saint-Brieuc, 22015
Centre de Radiothérapie
Strasbourg, 67000
Centre des Hautes Energies
Toulouse, 31400
Clinique Fleming
Tours, 37000
About this study
Official title: Trial UFT/RT Randomized Multicenter Phase III Randomized Trial Testing Ftorafur (UFT) Associated With Neoadjuvant Radiotherapy Versus Radiotherapy Alone in Rectal Adenocarcinoma
RATIONALE: Drugs used in chemotherapy, such as 5-fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing and also as a radiosensibilisant. Radiation therapy uses high-energy x-rays to kill tumor cells. 5-fluorouracil may make tumor cells more sensitive to radiation therapy. Oral 5-fluorouracil is more convenient for ambulatory patients. Giving UFT (Tegafur and Uracil) with radiation therapy before surgery may shrink the tumor so it can be removed.
PURPOSE: This phase III trial is studying how well giving UFT with radiation therapy works in treating patients who are undergoing surgery for operable rectal cancer.
Read the detailed description
Adenocarcinoma of the rectum
Stage II/stage III rectal cancer (if T4 only anal extension eligible)
Drug: UFT
Procedure: chemotherapy
Procedure: conventional surgery
Procedure: neoadjuvant therapy
Procedure: radiation therapy
Procedure: radiosensitization
Procedure: surgery
- Being tested
- Tegafur and Uracil
- Keywords
- rectal cancer, neoadjuvant therapy, UFT, radiochemotherapy
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tegafur and UracilDrug
| Study group | Role | What they receive |
|---|---|---|
| Tegafur uracile + radiotherapy | Experimental | Not described Receives: Drug: Tegafur and Uracil |
| radiotherapy | Active comparator | Not described Receives: Drug: Tegafur and Uracil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the rate of pathologic complete response of the primary tumor in patients with operable rectal cancer receiving preoperative chemoradiotherapy versus patients receiving radiotherapy alone
Secondary outcomes (7)
Compare endoscopic ultrasonographic response in patients with operable rectal cancer receiving preoperative chemoradiotherapy versus patients receiving radiotherapy alone.
Compare quality of life (Quality of Life Questionnaire Core 30 Items [QLQ-C 30])
Compare the rate of sphincter conservation alone.
Compare the safety of the chemoradiotherapy regimen to radiotherapy alone
Compare the rate of resectability with negative resection margins in patients treated with this two regimen.
Compare recurrence free survival and disease free survival
Compare overall survival
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startJul 2004
- Primary completionJun 2007
- Study completionFeb 2008
Why it stopped: Terminated after interim analysis
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 219 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Cancerologie de l'Ouest
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Patrice Cellier, MD, Study chair, Institut Cancerologie de l'OuestRémy Barraya, MD, Study chair, Institut Cancerologie de l'OuestChristian Chevelle, MD, Study chair, Centre des Hautes Energie, ToulouseGérard Lorimier, MD, Study chair, Institut Cancerologie de l'OuestVéronique Verrièle, MD, Study chair, Institut Cancerologie de l'OuestMichèle Boisdron, Pct, PhD, Study chair, Institut Cancerologie de l'OuestLoïc Campion, MD, Study chair, Centre René Gauducheau, Nantes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00207831
- Sponsor's protocol ID
- CPP276
- Acronym
- UFT RT Phase 3
- Status last verified
- Mar 2020
- First submitted
- 13 Sep 2005
- Last updated
- 25 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trial UFT/RT Randomized Multicenter Phase III Randomized Trial Testing Ftorafur (UFT) Associated With Neoadjuvant Radiotherapy Versus Radiotherapy Alone in Rectal Adenocarcinoma
- ClinicalTrials.gov ID
- NCT00207831
- Acronym / sponsor ID
- UFT RT Phase 3 / CPP276
- Keywords
- rectal cancer, neoadjuvant therapy, UFT, radiochemotherapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated after interim analysis
- Enrolment
- 219 participants (actual)
- Lead sponsor
- Institut Cancerologie de l'OuestUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Jul 2004 (actual)
- Primary completion
- Jun 2007 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 21 Sep 2005 (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 5-fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing and also as a radiosensibilisant. Radiation therapy uses high-energy x-rays to kill tumor cells. 5-fluorouracil may make tumor cells more sensitive to radiation therapy. Oral 5-fluorouracil is more convenient for ambulatory patients. Giving UFT (Tegafur and Uracil) with radiation therapy before surgery may shrink the tumor so it can be removed.
PURPOSE: This phase III trial is studying how well giving UFT with radiation therapy works in treating patients who are undergoing surgery for operable rectal cancer.
Detailed description
Adenocarcinoma of the rectum
Stage II/stage III rectal cancer (if T4 only anal extension eligible)
Drug: UFT
Procedure: chemotherapy
Procedure: conventional surgery
Procedure: neoadjuvant therapy
Procedure: radiation therapy
Procedure: radiosensitization
Procedure: surgery
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tegafur uracile + radiotherapy | Experimental | Drug: Tegafur and Uracil |
| radiotherapy | Active comparator | Drug: Tegafur and Uracil |
Who may qualify
- Ages
- 18 to 80 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 |
|---|---|---|
| Tegafur and Uracil | Drug | Tegafur uracile + radiotherapy, radiotherapy |
Primary outcome
Compare the rate of pathologic complete response of the primary tumor in patients with operable rectal cancer receiving preoperative chemoradiotherapy versus patients receiving radiotherapy alone
7 secondary outcomes
Compare endoscopic ultrasonographic response in patients with operable rectal cancer receiving preoperative chemoradiotherapy versus patients receiving radiotherapy alone.
Compare quality of life (Quality of Life Questionnaire Core 30 Items [QLQ-C 30])
Compare the rate of sphincter conservation alone.
Compare the safety of the chemoradiotherapy regimen to radiotherapy alone
Compare the rate of resectability with negative resection margins in patients treated with this two regimen.
Compare recurrence free survival and disease free survival
Compare overall survival
Results and safety
The study was stopped early (reason given: Terminated after interim analysis). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2020.
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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.
Patrice Cellier, MD study chair
Institut Cancerologie de l'Ouest
Rémy Barraya, MD study chair
Institut Cancerologie de l'Ouest
Christian Chevelle, MD study chair
Centre des Hautes Energie, Toulouse
27 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tegafur and Uracil in people with Rectal Cancer and Stage II/III, run by Institut Cancerologie de l'Ouest at 27 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: stopped early, as of the sponsor's last update on 25 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 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 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: Terminated after interim analysis). 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?
Compare the rate of pathologic complete response of the primary tumor in patients with operable rectal cancer receiving preoperative chemoradiotherapy versus patients receiving radiotherapy alone. It is what the study was designed to measure, not a finding.
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 25 Mar 2020.