Inoperable or Recurrent Rectal CancerPhase 2TOMUDEXNCT00590278
A Phase-II Study Of TOMUDEX Plus Radiotherapy In Subject With Inoperable or Recurrent Rectal Cancer
A Phase 2 study testing Tomudex, Radiotherapy and Haematology in people with Inoperable or Recurrent Rectal Cancer, run by AstraZeneca at 1 site in Turkey (Türkiye).
Trial summary
The pilot study is designed to investigate the value of Neo-adjuvant Tomudez in combination with radiotherapy in patients with inoperable or recurrent rectal cancer in terms of response rate and increasing the resectability of initially inoperable rectal cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inoperable or Recurrent Rectal Cancer
- What is being tested?
- Tomudex, Radiotherapy and Haematology
- Type of treatment
- Surgery or procedure
- How many people
- 49 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Aug 2002to 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed diagnosis of inoperable/recurrent rectal cancer
- Age > 18 years
- At least 1 measurable lesion should be present
- WHO performance score < 2
- Life expentancy of at least 12 weeks
- Subjects will be considered appropriate to receive systemic chemotherapy and pelvic radiotherapy
- Documented informed consent to participate in the trial
Who cannot join
- Previous systemic chemotherapy
- Previous radiotherapy to the planned exposure area
- Subjects with distant metastases
- (a)white blood cell < 4.0x109/L (unless absolute neutrophil count is >2.0x109/L or (b) Platelet count < 100x109/L
- Serum creatinine above the upper limit of the normal range
- (a) Serum bilirubin > 1.25 times the upper limit of the normal range or (b) Asparate aminotransferase(AST) or Alanine amiontransferase (ALT) >2.5 times the upper limit of the normal range
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- Any severe concurrent medical condition which would make it undesirable, in the clinician's opinion, for the patient to participate in the trial or which would jeopardise compliance with the trial period
- Pregnancy or breast feeding. Women of childbearing age must use effective contraception
- Previous or current malignancies at other sites, with the exception of adequately treated in-situ carcinoma of the cervix uteri and basal or squamous cell carcinoma of the skin
- Patient participation in other studies
Trial locations and contacts
1 site in 1 country.
About this study
The pilot study is designed to investigate the value of Neo-adjuvant Tomudez in combination with radiotherapy in patients with inoperable or recurrent rectal cancer in terms of response rate and increasing the resectability of initially inoperable rectal cancer.
- Conditions
- Inoperable or Recurrent Rectal Cancer
- Being tested
- Tomudex, Radiotherapy, Haematology, Biochemistry
- Keywords
- Tomudex, inoperable rectal cancer, recurrent rectal cancer
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TomudexDrug
RadiotherapyProcedure or surgery
HaematologyProcedure or surgery
BiochemistryProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
This study will evaluate the value of TOMUDEX in combination with a 'standard' course of pelvic radiotherapy for inoperable/recurrent rectal cancer, in terms of response rate and increasing the resectability rate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2008 (estimated)
- Study startAug 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inoperable or Recurrent Rectal CancerStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe 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
- Single group
- Masking
- None (open label)
- Enrolment
- 49 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Tayfun Hancilar, MD, Principal investigator, Okmeydani Hospital Istanbul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00590278
- Sponsor's protocol ID
- 1694TR/01
- Acronym
- TOMUDEX
- Status last verified
- Jan 2008
- First submitted
- 26 Dec 2007
- Last updated
- 25 Jan 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase-II Study Of TOMUDEX Plus Radiotherapy In Subject With Inoperable or Recurrent Rectal Cancer
- ClinicalTrials.gov ID
- NCT00590278
- Acronym / sponsor ID
- TOMUDEX / 1694TR/01
- Conditions
- Inoperable or Recurrent Rectal Cancer
- Keywords
- Tomudex, inoperable rectal cancer, recurrent rectal cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Aug 2002
- First posted
- 10 Jan 2008 (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.
The pilot study is designed to investigate the value of Neo-adjuvant Tomudez in combination with radiotherapy in patients with inoperable or recurrent rectal cancer in terms of response rate and increasing the resectability of initially inoperable rectal cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Confirmed diagnosis of inoperable/recurrent rectal cancer
- Age > 18 years
- At least 1 measurable lesion should be present
- WHO performance score < 2
- Life expentancy of at least 12 weeks
Key exclusion criteria (10 listed)
- Previous systemic chemotherapy
- Previous radiotherapy to the planned exposure area
- Subjects with distant metastases
- (a)white blood cell < 4.0x109/L (unless absolute neutrophil count is >2.0x109/L or (b) Platelet count < 100x109/L
- Serum creatinine above the upper limit of the normal range
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 |
|---|---|---|
| Tomudex | Drug | – |
| Radiotherapy | Procedure or surgery | – |
| Haematology | Procedure or surgery | – |
| Biochemistry | Procedure or surgery | – |
Primary outcome
This study will evaluate the value of TOMUDEX in combination with a 'standard' course of pelvic radiotherapy for inoperable/recurrent rectal cancer, in terms of response rate and increasing the resectability rate
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 25 Jan 2008.
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.
Tayfun Hancilar, MD principal investigator
Okmeydani Hospital Istanbul
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 Tomudex, Radiotherapy and Haematology in people with Inoperable or Recurrent Rectal Cancer, run by AstraZeneca at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. 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 25 Jan 2008. 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 Turkey (Türkiye). 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.
What does the primary outcome measure?
This study will evaluate the value of TOMUDEX in combination with a 'standard' course of pelvic radiotherapy for inoperable/recurrent rectal cancer, in terms of response rate and increasing the resectability rate. 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 Jan 2008; AzTrials last refreshed its copy on 26 Oct 2026.