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Rectal CancerPhase 2xeberectoNCT00847119

Xeloda and Bevacizumab to Treat Rectal Cancer

A Phase 2 study testing Bevacizumab, capecitabine (Xeloda) and Rectal Radiotherapy in people with Rectal Cancer, run by Institut Català d'Oncologia at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The project objective is to evaluate the efficacy of the neoadjuvant treatment with bevacizumab, capecitabine and radiotherapy, in patients with rectal adenocarcinoma resectable locally advanced (stage T3 or T4), with or without presence of ganglionar metastases and without distant metastases. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Rectal Cancer
What is being tested?
Bevacizumab, capecitabine (Xeloda) and Rectal Radiotherapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
43 participants
Where
1 siteSpain
Study dates
Sep 2007to Feb 2015
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The patient has given written informed consent prior to any study related procedure
  • Male and female aged 18 to 75 years
  • ECOG performance status 0 or 1
  • Histologically confirmed diagnostic of adenocarcinoma of the rectum < 15 cm from anal verge
  • Clinical stage of T3, T4 with/without regional lymph node metastases, without metastatic disease
  • Disease evaluable by imaging techniques
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  • No tumour haemorrhage in the week prior to start of study treatment
  • External derivation in symptomatic occlusive tumours
  • Not prior cancer treatment
  • Adequate bone marrow, hepatic and renal function, defined as:
  • White blood cells ≥ 4 x 109 /l
  • Absolute neutrophil count ≥ 1.5 x 109 /l
  • Platelets ≥ 100 x 109 /l
  • Haemoglobin ≥10 g/dl
  • Bilirubin < 1.25 x upper limit of normal
  • Aspartate transaminase and alanine transaminase < 2.5 x upper limit of normal
  • Serum creatinine ≤ 106 µmol/l
  • Less than 10% weight loss

Who cannot join

  • Rectal cancer no amenable to resection
  • Any other malignancy which has been active or treated within the past 5 years , with the exception of in situ carcinoma of the cervix and non-melanoma skin lesions adequately treated
  • Pregnant or breast-feeding women
  • Women oh childbearing potential unless effective methods of contraception are used
  • No prior or concurrent significant medical conditions, including any of the following:
  • Cerebrovascular disease (including transient ischemic attack and stroke) within the past year
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  • Cardiovascular disease, including the following:
  • Myocardial infarction within the past year
  • Uncontrolled hypertension while receiving chronic medication
  • Unstable angina
  • New York Heart Association class II-IV congestive heart failure
  • Serious cardiac arrhythmia requiring medication
  • Major trauma within the past 28 days
  • Serious nonhealing wound, ulcer, or bone fracture
  • Evidence of bleeding diathesis or coagulopathy
  • No lack of physical integrity of the upper gastrointestinal tract, malabsorption syndrome, or inability to take oral medication
  • No evidence of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug
  • No known dihydropyrimidine dehydrogenase deficiency
  • Major surgery in the 4 weeks prior to the start of study treatment
  • No concurrent chronic, daily treatment with aspirin (> 325 mg/day)
  • More than 10 days since prior use of full-dose oral or parenteral anticoagulants for therapeutic purposes
  • No participation in another clinical trial with any investigational drug within 30 days prior to randomization or during study participation
  • No other medical history or condition that, in the opinion of the investigator, would preclude study participation

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Institut Català d'Oncologia-L'Hospitalet

    L'Hospitalet Del Llobregat, Barcelona, 08907

Other trials in Spain

About this study

Official title: ESTUDIO FASE II DE BEVACIZUMAB EN COMBINACIÓN CON CAPECITABINA Y RADIOTERAPIA COMO TRATAMIENTO PREOPERATORIO EN PACIENTES CON CÁNCER RECTAL LOCALMENTE AVANZADO RESECABLE

The project objective is to evaluate the efficacy of the neoadjuvant treatment with bevacizumab, capecitabine and radiotherapy, in patients with rectal adenocarcinoma resectable locally advanced (stage T3 or T4), with or without presence of ganglionar metastases and without distant metastases.

Conditions
Rectal Cancer
Being tested
Bevacizumab, capecitabine (Xeloda), Rectal Radiotherapy
Keywords
rectum, adenocarcinoma, neoadjuvant, bevacizumab, capecitabine, radiotherapy, locally, advanced, resectable, resectable locally advanced adenocarcinoma of the rectum, xeberecto
Medical subject headings
Rectal Neoplasms, Adenocarcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BevacizumabBiological

    Bevacizumab 4 cycles each 15 days, the first 10 mg/kg and the rest of cycles with 5 mg/kg.

  • capecitabine (Xeloda)Drug

    Capecitabine 900 mg/m2 two times a day concomitant during radiotherapy period

  • Rectal RadiotherapyRadiation

    Radiotherapy in rectum 45 Gy starting on Bevacizumab 2nd cycle during 5 weeks, 1.8 Gy per day, 5 days at week.

Study groups in NCT00847119
Study groupRoleWhat they receive
Bevacizumab & capecitabine & radiotheraphyExperimentalBevacizumab 4 cycles each 15 days, the first 10 mg/kg and the rest of cycles with 5 mg/kg. Radiotherapy 45 Gy starting on Bevacizumab 2nd cycle during 5 weeks, 1.8 Gy per day, 5 days at week. Capecitabine 900 mg/m2 two times a day concomitant during radiotherapy period.
Receives: Biological: Bevacizumab; Drug: capecitabine (Xeloda); Radiation: Rectal Radiotherapy

What is being measured

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

  1. Pathologic complete response rate. % patients with pathologic complete response (absence of tumoral cells in the resected piece)

    Measured: Surgery date

Secondary outcomes (8)

  1. Overall clinical response

    Measured: Surgery date

  2. To determine the downstaging caused by treatment

    Measured: Surgery date

  3. relapse free survival

    Measured: Time of radiological evidence of relapse.

  4. Quantify the local control grade: R0 resections in surgery

    Measured: Surgery date

  5. Local relapse and distant relapse rates

    Measured: Relapse date

  6. To determine the security profile of this neoadjuvant treatment (radio- chemotherapy)

    Measured: From date of register to surgery date

  7. Surgery complication rate

    Measured: During surgery admission.

  8. To determine the angiogenic profile changes in tumour.

    Measured: 15 days, 6 weeks and 4 months

Timeline

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

  1. First posted19 Feb 2009 (estimated)
  2. Study startSep 2007
  3. Primary completionJun 2011
  4. Study completionFeb 2015

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
43 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00847119
Sponsor's protocol ID
ML 20006. XEBERECTO/ICO/005
Other IDs
EudraCT number:2007-000456-13
Acronym
xeberecto
Status last verified
Aug 2017
First submitted
18 Feb 2009
Last updated
29 Aug 2017
Results posted
No
Data monitoring committee
No

Publications

  • Garcia M, Martinez-Villacampa M, Santos C, Navarro V, Teule A, Losa F, Pisa A, Cambray M, Soler G, Lema L, Kreisler E, Figueras A, Juan XS, Vinals F, Biondo S, Salazar R. Phase II study of preoperative bevacizumab, capecitabine and radiotherapy for resectable locally-advanced rectal cancer. BMC Cancer. 2015 Feb 26;15:59. doi: 10.1186/s12885-015-1052-0.

    PubMed 25886275

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Bevacizumab, capecitabine (Xeloda) and Rectal Radiotherapy in people with Rectal Cancer, run by Institut Català d'Oncologia at 1 site in Spain.

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 18 inclusion and 23 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 29 Aug 2017. 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 Spain. 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?

Pathologic complete response rate. % patients with pathologic complete response (absence of tumoral cells in the resected piece) (time frame: Surgery date). 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 NCT00847119, 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 29 Aug 2017.

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