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Rectum CancerPhase 2NCT00909987

Study of Neoadjuvant CT With Selective Radiotherapy in Patients With Intermediate-Risk Cancer Rectum

A Phase 2 study testing Capecitabine, Oxaliplatin and Bevacizumab in people with Rectum Cancer, run by Grupo Espanol Multidisciplinario del Cancer Digestivo at 12 sites in Spain.

Completed

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

Official record
Search all trials

Trial summary

Phase II, Multicenter, Open-label, Non-randomized Study of Neoadjuvant Chemotherapy (CAPECITABINE-OXALIPLATIN + BEVACIZUMAB) with Selective Radiotherapy and Chemotherapy with CAPECITABINE Use in Patients with Intermediate-Risk Cancer of the Rectum Defined by Magnetic Resonance Imaging. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Rectum Cancer
What is being tested?
Capecitabine, Oxaliplatin and Bevacizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
46 participants
Where
12 sitesSpain
Study dates
Mar 2009to Jun 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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patient ≥18 years
  • Tumor biopsy with histopathologic confirmation of rectal adenocarcinoma as primary histology
  • Patient with measurable disease at the baseline visit
  • T3 tumor that meets all the following criteria in high-resolution magnetic resonance imaging (MRI) (3-mm slices) of the pelvis: distal border of tumor more than 5cm form the external edge of the anus and below the sacral promontory (located in the anatomy rectum).
  • Candidate for complete surgical resection (R0) with sphincter preservation surgery, prior to the administration of any therapy
  • Candidate for systemic therapy with XELOX/BVZ
Show all 9Show fewer
  • ECOG: 0-2
  • ANC≥1.5 cells/mm3, Hb>8.0 g/dL, platelets>150,000/mm3 in 2 previous weeks
  • Patient who signed the informed consent

Who cannot join

  • Stage T4.
  • Distant metastases
  • Tumor with an intraperitoneal distal border
  • Tumor presenting initially in a low location and judged, prior to any treatment, to require abdominoperineal resection
  • Previous chemotherapy for colorectal cancer or incomplete recovery from oncologic surgery or other previous major surgery that, in the opinion of the investigator, precludes the use of a combined modality therapy
  • Serum creatinine <1.5 ULN
Show all 16Show fewer
  • Patient who has received previous pelvic radiotherapy
  • Patient with an uncontrolled infection
  • Presence of a high degree of obstruction (intestinal lumen ≤ 1 cm), unless the patient has undergone protective surgical bypass or an endoscopic stent procedure
  • Pt with a history of an arterial thromboembolic event during the previous year.This includes angina (stable or unstable),myocardial infarction (MI),cerebrovascular accident (CVA),or other relevant history in the opinion of the investigator.Note: A patient with a history of thrombotic events, such as deep venous thrombosis, pulmonary embolism, MI or ACV, within the 6 months preceding recruitment may be considered for participation in the clinical trial if they are receiving stable doses of anticoagulant therapy. Similarly, patients being anticoagulated for atrial fibrillation or other conditions can participate if they are receiving a stable dosage of anticoagulant therapy. Clinicians must consider the higher risk of therapy with BVZ among patients with a history of thromboembolic disorders so the decision to allow the patients to participate remains at the discretion of the physician
  • Previous treatment with another investigational antitumoral therapy in the 30 days prior to beginning treatment
  • History of previous malignancy in the past 5 years, excepting basocellular or squamous cell skin cancer, or properly treated cervix cancer in situ
  • Woman with a positive pregnancy test in urine or serum during recruitment, prior to the administration of the study medication, or within 72 hours of beginning to take the study medication, or a woman who is nursing
  • WOCBP who does not wish to use or cannot use an effective contraceptive method to avoid pregnancy during the complete study period up to 4 weeks after ending the study.Male subjects also must agree to use an effective method of contraception.Note: WOCBP refers to any woman who has experienced menarche and has not undergone successful surgical sterilization or is not postmenopausal (defined as amenorrhea≥12 consecutive months,or women with hormonal replacement therapy and documented serum levels of follicle stimulating hormone).Even women who are using oral, implanted or injectable contraceptive hormones, mechanical products such as an intrauterine device or barrier methods to prevent pregnancy,or who practice abstinence or have a sterile partner, must be assumed to be WOCBP
  • Patient with any other condition or concurrent medical or psychiatric disease who,in opinion of the investigator, is not eligible to enter the study
  • Known hypersensitivity to any component of the study drug (XELOX/bevacizumab) or radiotherapy

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

Spain12 sites

  • Hospital del Mar

    Barcelona, Barcelona, 08003

  • Hospital de La Santa Creu I Sant Pau

    Barcelona, Barcelona, 08025

  • Hospital Clinic i Provincial de Barcelona

    Barcelona, Barcelona, 08036

  • Hospital General Universitario de Elche

    Elche, Alicante, 03203

  • Hospital Arnau de Vilanova

    Lleida, Lérida, 25198

  • Hospital La Paz

    Madrid, Madrid, 28046

  • Hospital de Navarra

    Pamplona, Pamplona, 31008

  • Complejo Sanitario Parc Taulí

    Sabadell, Barcelona, 08208

  • Hospital La Fe

    Valencia, Valencia, 46009

  • Instituto Valenciano de Oncología (IVO)

    Valencia, Valencia, 46009

  • Hospital General de Valencia

    Valencia, Valencia, 46014

  • Hospital Miguel Servet

    Zaragoza, Zaragoza, 50009

Other trials in Spain

About this study

Official title: Phase II, Multicenter, Open-label, Non-randomized Study of Neoadjuvant Chemotherapy With Selective Radiotherapy Use in Patients With Intermediate-Risk Cancer of the Rectum Defined by Magnetic Resonance Imaging

Phase II, Multicenter, Open-label, Non-randomized Study of Neoadjuvant Chemotherapy (CAPECITABINE-OXALIPLATIN + BEVACIZUMAB) with Selective Radiotherapy and Chemotherapy with CAPECITABINE Use in Patients with Intermediate-Risk Cancer of the Rectum Defined by Magnetic Resonance Imaging.

Read the detailed description

XELOX / Bevacizumab will be administrated for 3 cycles over a 9 week period. XELOX without Bevacizumab will be administrated for an additional cycle over a 4 week period. Patients will undergo re-staging within 3 weeks of their 4th cycle of XELOX. This will include MRI of the pelvis. If the reassessment reveals that there has been no disease progression compared to the pre-treatment evaluation and the patient remains a candidate for an R0 resection, the patient will proceed to definitive rectal cancer surgery within 4 weeks from the last chemotherapy dose. If the surgical oncologist's reassessment reveals that the patient is not a candidate for an R0 resection, the patient will proceed to standard pre-operative radiation with synchronous Capecitabine.

Conditions
Rectum Cancer
Being tested
Capecitabine, Oxaliplatin, Bevacizumab, Radiotherapy, Capecitabine during all Radiotherapy period
Keywords
rectum, intermediate risk cancer rectum, neoadjuvant
Medical subject headings
Rectal Neoplasms

What participants receive

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

  • CapecitabineDrug

    Also called Xeloda

    PO 1000 mg/m2 bid during day 1 to 15 for 3 cycles (every cycle has 3 weeks)

  • OxaliplatinDrug

    IV 130 mg/m2 during day 1 for 3 cycles (every cycle has 3 weeks)

  • BevacizumabDrug

    Also called Avastin

    IV 7.5 mg/Kg during 30 minutes day 1 during 4 cycles (every cycle has 3 weeks)

  • RadiotherapyRadiation

    Also called Neoadjuvant Radiotherapy

    Total dose 50.4 Gy administered during 28 days (1.8 Gy/day in 5 weeks).

  • Capecitabine during all Radiotherapy periodDrug

    Also called Xeloda

    825 mg/m2 bid

  • Total Mesorectal Excision (TME)Procedure or surgery

    4 weeks from the last chemotherapy dose. In those patients who receive radiation TME wil be performed six weeks after

Study groups in NCT00909987
Study groupRoleWhat they receive
Single armExperimentalNeoadyuvant chemotherapy with XELOX: Xeloda 1000mg/m2/12h dayly, day one in the afternoon until day 15 in the morning; plus oxaliplatin 130mg/m2 (day 1); and Bevacizumab 7.5 mg/kg (day 1)during 3 cycles (each cycle of 3 weeks). Followed by a selective use of chemoradiotherapy with radiotherapy (50.4Gy, 28 sesions of 1.8Gy during 5 weeks) plus Xeloda 825mg/m2/12h dayly.
Receives: Drug: Capecitabine; Drug: Oxaliplatin; Drug: Bevacizumab; Radiation: Radiotherapy; Drug: Capecitabine during all Radiotherapy period; Procedure: Total Mesorectal Excision (TME)

What is being measured

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

  1. Efficacy of XELOX/BVZ neoadjuvant therapy with selective radiotherapy use in patients with locally advanced tumors of the rectum, measured in terms of the proportion of responders (PCR + CCR), according to RECIST criteria

    Measured: Until the end of study

Secondary outcomes (6)

  1. Study treatment,which selectively omits neoadjuvant irradiation,can achieve a R0= 90%

    Measured: At least 3 years for local recurrence and systemic recurrence

  2. Rate of local and systemic recurrence

    Measured: At least 3 years for local recurrence and systemic recurrence

  3. Toxicity of treatment

    Measured: At least 3 years for local recurrence and systemic recurrence

  4. Rate of surgical complications during postoperative

    Measured: At least 3 years for local recurrence and systemic recurrence

  5. Profile of gene expression before neoadjuvant treatment

    Measured: At least 3 years for local recurrence and systemic recurrence

  6. Complete Phatologic Response (pCR)

    Complete pathologic response (pCR)estimated according to the number of subjects that showed yPT0N0 divided by the total number of subjects.

    Measured: 2012

Timeline

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

  1. First posted29 May 2009 (estimated)
  2. Study startMar 2009
  3. Primary completionJan 2013
  4. Study completionJun 2013

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
46 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00909987
Sponsor's protocol ID
GEMCAD-0801
Status last verified
Sep 2013
First submitted
23 Mar 2009
Last updated
11 Oct 2013
Results posted
No
Data monitoring committee
No

Publications

  • Fernandez-Martos C, Brown G, Estevan R, Salud A, Montagut C, Maurel J, Safont MJ, Aparicio J, Feliu J, Vera R, Alonso V, Gallego J, Martin M, Pera M, Sierra E, Serra J, Delgado S, Roig JV, Santos J, Pericay C. Preoperative chemotherapy in patients with intermediate-risk rectal adenocarcinoma selected by high-resolution magnetic resonance imaging: the GEMCAD 0801 Phase II Multicenter Trial. Oncologist. 2014 Oct;19(10):1042-3. doi: 10.1634/theoncologist.2014-0233. Epub 2014 Sep 10.

    PubMed 25209376

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Capecitabine, Oxaliplatin and Bevacizumab in people with Rectum Cancer, run by Grupo Espanol Multidisciplinario del Cancer Digestivo at 12 sites 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 9 inclusion and 16 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 11 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites 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?

Efficacy of XELOX/BVZ neoadjuvant therapy with selective radiotherapy use in patients with locally advanced tumors of the rectum, measured in terms of the proportion of responders (PCR + CCR), according to RECIST criteria (time frame: Until the end of study). 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 NCT00909987, 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 11 Oct 2013.

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