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Rectal Cancers.Phase 2NCT01340508

Preoperative Concurrent Chemotherapy and Intensity Modulated Radiotherapy (IMRT) in Locally Advanced Rectal Cancer

A Phase 2 study testing Intensity Modulated Radiotherapy in people with Rectal Cancers., run by National University Hospital, Singapore at 1 site in Singapore.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The hypothesis of this study is that dose escalated intensity modulated radiotherapy (IMRT) to a dose of 55Gy in 25# to primary rectal tumor concurrent with oral capecitabine results in an improved pathological response rate from 8% (German trial) to 25%. Read more about this study

Who is it for?
Ages 21 to 90 years
Conditions the study is for
Rectal Cancers.
What is being tested?
Intensity Modulated Radiotherapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
63 participants
Where
1 siteSingapore
Study dates
Jan 2011to Jan 2013
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 21 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Pathologically proven diagnosis of adenocarcinoma of the rectum
  • Clinically determined to be stage T3 or T4,N0-N2, and M0 -staged by MRI or transrectal ultrasound of the rectum
  • Patients who are medically operable and who have resectable adenocarcinoma of the rectum at least <15cm from the anal verge
  • Adequate liver/renal and haematological function.
  • Eastern Cooperative Oncology Group (ECOG) performance 0-2
  • Age ≥ 18 years
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  • Full blood count obtained within 2 weeks prior to registration on study, with adequate bone marrow function defined as follows:
  • Absolute neutrophil count (ANC) ≥ 1,800 cells/mm3
  • Platelets ≥ 100,000 cells/mm3
  • Haemoglobin ≥ 8.0 g/dl
  • Serum creatinine within normal institutional limits or creatinine clearance ≥ 50 ml/min
  • Bilirubin within normal institutional limits
  • AST and ALT < 2.5 x the IULN
  • Patient must sign study specific informed consent prior to study entry

Who cannot join

  • Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years
  • Prior systemic chemotherapy for colorectal cancer; note that prior chemotherapy for a different cancer is allowable.
  • Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
  • Severe, active comorbidity, defined as follows:
  • Unstable angina and/or congestive heart failure requiring hospitalization within the last 12 months
  • Transmural myocardial infarction within the last 6 months
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  • Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
  • Acquired immune deficiency syndrome (AIDS) based upon current CDC definition; note, however, that HIV testing is not required for entry into this protocol.
  • Evidence of uncontrolled seizures, central nervous system disorders, or psychiatric disability judged by the investigator to be clinically significant, precluding informed consent, or interfering with compliance of oral drug intake.
  • Known, existing uncontrolled coagulopathy. Patients on therapeutic anticoagulation may be enrolled provided that they have been clinically stable on anti-coagulation for at least 2 weeks.
  • Major surgery within 28 days of study enrollment (other than diverting colostomy)
  • Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic
  • Prior allergic reaction to capecitabine
  • Any evidence of distant metastases (M1)
  • A synchronous primary colon carcinoma
  • Extension of malignant disease into the anal canal
  • Lack of physical integrity of the gastrointestinal tract (i.e., severe Crohn's disease that results in
  • malabsorption; significant bowel resection that would make one concerned about the absorption of capecitabine) or malabsorption syndrome that would preclude feasibility of oral chemotherapy (capecitabine)
  • Participation in any investigational drug study within 28 days of study enrollment

Trial locations and contacts

1 site in 1 country.

Singapore1 site, 1 recruiting

  • National University Hospital

    Singapore, Singapore, 119074

    Jeremy Tey, FRANZCR, + 6567724869, Jeremy_tey@nuhs.edu.sg

    Jeremy Tey, FRANZCR

    Recruiting

Other trials in Singapore

About this study

Official title: A Phase II Trial of Preoperative Concurrent Chemotherapy and (IMRT) in Locally Advanced Rectal Cancer

The hypothesis of this study is that dose escalated intensity modulated radiotherapy (IMRT) to a dose of 55Gy in 25# to primary rectal tumor concurrent with oral capecitabine results in an improved pathological response rate from 8% (German trial) to 25%.

Read the detailed description

This study aims to look at whether radiation dose escalation with intensity modulated radiotherapy can increase the rates of pathological complete response in patients with locally advanced rectal cancer treated with neoadjuvant chemoradiotherapy

Conditions
Rectal Cancers.
Being tested
Intensity Modulated Radiotherapy
Keywords
Pathological complete response, Intensity modulated radiotherapy, 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.

  • Intensity Modulated RadiotherapyRadiation

    Also called Intensity modulated radiotherapy. Dose escalation.

    Intensity modulated radiotherapy to a dose of 55Gy in 25 fractions

Study groups in NCT01340508
Study groupRoleWhat they receive
Intensity modulated RadiotherapyExperimentalIntensity modulated radiotherapy, dose escalation, rectal cancer, volumetric modulated arc therapy
Receives: Radiation: Intensity Modulated Radiotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pathological complete response rates

    Pathogical complete response rate 8 weeks post chemoradiotherapy at surgery according to Ryan's classification

    Measured: 8 weeks post chemoradiotherapy

Secondary outcomes (4)

  1. Toxicity

    Toxicity including anorexia, nausea, vomiting, diarrhoea, dermatitis, proctitis, urinary frequency/urgency as per common toxicity criteria v3.0

    Measured: 2 years

  2. Disease Free survival

    Time from study entry to disease recurrence or death

    Measured: 2 years

  3. Downstaging rates

    percentage of patients who achieve downstaging 8 weeks post chemoradiotherapy at surgery according to TNM classification

    Measured: 8 weeks after chemoradiotherapy

  4. Sphincter Preservation rates

    Sphincter Preservation rates 8 weeks post chemoradiotherapy at surgery.Percentage of patients who underwent sphincter salvage surgery after chemoradiotherapy

    Measured: 8 weeks after chemoradiotherapy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Apr 2011 (estimated)
  2. Study startJan 2011
  3. Primary completionJan 2013 (estimated)
  4. Study completionJan 2013 (estimated)

Resources

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
63 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01340508
Sponsor's protocol ID
B/09/377
Status last verified
Apr 2011
First submitted
18 Apr 2011
Last updated
22 Apr 2011
Results posted
No
Data monitoring committee
Yes

Publications

  • Ryan R, Gibbons D, Hyland JM, Treanor D, White A, Mulcahy HE, O'Donoghue DP, Moriarty M, Fennelly D, Sheahan K. Pathological response following long-course neoadjuvant chemoradiotherapy for locally advanced rectal cancer. Histopathology. 2005 Aug;47(2):141-6. doi: 10.1111/j.1365-2559.2005.02176.x.

    PubMed 16045774

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Intensity Modulated Radiotherapy in people with Rectal Cancers., run by National University Hospital, Singapore at 1 site in Singapore.

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 14 inclusion and 19 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: status not confirmed, as of the sponsor's last update on 22 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 Singapore. 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?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pathological complete response rates (time frame: 8 weeks post chemoradiotherapy). 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 NCT01340508, 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 22 Apr 2011.

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