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Rectal CancerPhase 2AVAXELNCT01043484

Safety and Efficacy Study to Compare Capecitabine + Bevacizumab Versus Capecitabine, Concomitantly With Radiotherapy as Neoadjuvant Treatment for Patients With Localized and Resectable Rectal Cancer

A Phase 2 study testing Bevacizumab + Capecitabine + Radiotherapy and Capecitabine + Radiotherapy in people with Rectal Cancer, run by Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD) 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 purpose of the study is to evaluate the efficacy and safety of the combination of capecitabine + bevacizumab concomitantly with radiotherapy versus capecitabine concomitantly with radiotherapy, as neoadjuvant treatment for patients with localized and resectable rectal cancer. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Rectal Cancer
What is being tested?
Bevacizumab + Capecitabine + Radiotherapy and Capecitabine + Radiotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
1 siteSpain
Study dates
Dec 2009to Aug 2016
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

  • Written informed consent
  • Age ≥18 years
  • ECOG ≤ 1
  • Histologically confirmed carcinoma of the rectum
  • Localized and resectable rectal cancer
  • No metastatic disease
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  • Measurable disease
  • Life expectancy more than 4 months
  • Non prior treatment for rectal cancer
  • Adequate haematological function: leu ≥ 4x 109 /l, Hb ≥10 gr/dl, neutropils≥ 1,5 x 109 /l and platelets ≥100 x 109 /l
  • Adequate renal function: creatinine ≤ 106 umol/l or calculated creatinine clearance > 50 mL/min
  • Adequate liver function: AST, ALT and alkaline phosphatase ≤2.5 x UL, bilirubin ≤1.5 x UL
  • Adequate nutritional weight loss <10% of regular weight and albumin ≥ 35 g/l

Who cannot join

  • Unresectable rectal cancer
  • Past or current history (within the last 5 years prior to treatment start) of other malignancies.
  • Patients of childbearing potential not willing to use effective means of contraception.
  • Clinically significant cardiovascular disease
  • Lack of physical integrity of the upper gastrointestinal tract, malabsorption syndrome or inability to take oral medication.
  • Patients subjected to organ allografts who require immunosuppressive treatment.
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  • Severe, non-cicatrized osseous fractures, wounds or ulcers.
  • Indications of hemorrhagic diathesis or coagulopathy.
  • Severe, uncontrolled intercurrent infections or other severe, uncontrolled concomitant diseases.
  • History of unexpected severe reactions to treatment with fluoropyrimidines or known deficiency dihydropyrimidine dehydrogenase deficiency (DPD).
  • Patients subjected to a major surgical procedure, open biopsy or who have had significant traumatic lesions within the 28 days prior to beginning the treatment of the study or in whom it is foreseen that a major surgical procedure will be necessary during the course of the study; fine-needle aspiration within the 7 days prior to beginning the treatment of the study.
  • Current or recent use (within the 10 days prior to beginning the treatment of the study) of oral or parenteral anticoagulants at complete doses or thrombolytic agents. The use of low doses of warfarin is allowed, with an International Normalized Ratio [INR] of < 1.5.
  • Daily chronic treatment with high doses of aspirin (> 325 mg/day) or non-steroid anti-inflammatory medications (which inhibit the platelet function at doses used for treating chronic inflammatory diseases).
  • Patients who have received any drug or agent/procedure under research, i.e., who have participated in another clinical trial during the 4 weeks prior to beginning the treatment with the medications of the study
  • Any psychological, familiar conditions suggesting that the patient will not be able to complete the study

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Spanish Cooperative Group for Gastrointestinal Tumour Therapy

    Madrid, 28046

Other trials in Spain

About this study

Official title: Phase II Randomized Study to Compare Capecitabine + Bevacizumab Concomitantly With Radiotherapy Versus Capecitabine Concomitantly With Radiotherapy, as Neoadjuvant Treatment for Patients With Localized and Resectable Rectal Cancer

The purpose of the study is to evaluate the efficacy and safety of the combination of capecitabine + bevacizumab concomitantly with radiotherapy versus capecitabine concomitantly with radiotherapy, as neoadjuvant treatment for patients with localized and resectable rectal cancer.

Conditions
Rectal Cancer
Being tested
Bevacizumab + Capecitabine + Radiotherapy, Capecitabine + Radiotherapy
Keywords
Resectable rectal cancer, Radiotherapy, Bevacizumab, Capecitabine
Medical subject headings
Rectal Neoplasms

What participants receive

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

  • Bevacizumab + Capecitabine + RadiotherapyDrug

    Bevacizumab (5 mg/kg; days 1, 15 and 29) Capecitabine (825 mg/m2/12h, 5 days/w) Radiotherapy (45 Gy in sessions of 1.8 Gy 5 times/w for 5 weeks)

  • Capecitabine + RadiotherapyDrug

    Capecitabine (825 mg/m2/12h, 5 days/w) and Radiotherapy (45 Gy in sessions of 1.8 Gy 5 times/w for 5 weeks)

Study groups in NCT01043484
Study groupRoleWhat they receive
AExperimentalBevacizumab + Capecitabine + Radiotherapy
Receives: Drug: Bevacizumab + Capecitabine + Radiotherapy
BActive comparatorCapecitabine + Radiotherapy
Receives: Drug: Capecitabine + Radiotherapy

What is being measured

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

  1. Rate complete pathologic responses

    Measured: 17 months

Secondary outcomes (8)

  1. Disease free survival at 3 and 5 years

    Measured: 78 months

  2. Rate of local and distant recurrence at 3 and 5 years

    Measured: 78 months

  3. Overall survival at 3 and 5 years

    Measured: 78 months

  4. R0 resection rate.

    Measured: 17 months

  5. Adverse events

    Measured: 17 months

  6. Rate of surgery complications

    Measured: 17 months

  7. Molecular predictive markers: changes in angiogenic parameters, vascular endothelial growth factor (VEGF), vascular endothelial growth factor receptors, microvessel quantification and angiopoietin-2 (Ang-2)

    Measured: 17 months

  8. Rate of sphincter preservation

    Measured: 17 months

Timeline

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

  1. First posted6 Jan 2010 (estimated)
  2. Study startDec 2009
  3. Primary completionJan 2013
  4. Study completionAug 2016

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01043484
Sponsor's protocol ID
TTD-08-05
Other IDs
EudraCT: 2009-010192-24
Acronym
AVAXEL
Status last verified
Oct 2016
First submitted
30 Dec 2009
Last updated
19 Oct 2016
Results posted
No
Data monitoring committee
No

Publications

  • Salazar R, Capdevila J, Manzano JL, Pericay C, Martinez-Villacampa M, Lopez C, Losa F, Safont MJ, Gomez-Espana A, Alonso-Orduna V, Escudero P, Gallego J, Garcia-Paredes B, Palacios A, Biondo S, Gravalos C, Aranda E; Spanish Cooperative Group for the Treatment of Digestive Tumors (TTD). Phase II randomized trial of capecitabine with bevacizumab and external beam radiation therapy as preoperative treatment for patients with resectable locally advanced rectal adenocarcinoma: long term results. BMC Cancer. 2020 Nov 27;20(1):1164. doi: 10.1186/s12885-020-07661-z.

    PubMed 33246428

  • Salazar R, Capdevila J, Laquente B, Manzano JL, Pericay C, Villacampa MM, Lopez C, Losa F, Safont MJ, Gomez A, Alonso V, Escudero P, Gallego J, Sastre J, Gravalos C, Biondo S, Palacios A, Aranda E. A randomized phase II study of capecitabine-based chemoradiation with or without bevacizumab in resectable locally advanced rectal cancer: clinical and biological features. BMC Cancer. 2015 Feb 26;15:60. doi: 10.1186/s12885-015-1053-z.

    PubMed 25886378

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Bevacizumab + Capecitabine + Radiotherapy and Capecitabine + Radiotherapy in people with Rectal Cancer, run by Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD) 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 13 inclusion and 15 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 19 Oct 2016. 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?

Rate complete pathologic responses (time frame: 17 months). 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 NCT01043484, which also lists 2 linked publications.

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 19 Oct 2016.

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