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Rectal AdenocarcinomaPhase 2New BeatNCT01554059

Neoadjuvant Chemoradiation With Bevacizumab for Chinese Rectal Cancer Patients

A Phase 2 study testing Bevacizumab, Oxaliplatin and 5-FU in people with Rectal Adenocarcinoma, run by Sixth Affiliated Hospital, Sun Yat-sen University at 2 sites in China.

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 cytotoxic chemotherapy (Oxaliplatin and 5Fu) with bevacizumab concomitantly with radiotherapy as neoadjuvant treatment for patients with locally advanced but resectable rectal adenocarcinoma. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Rectal Adenocarcinoma
What is being tested?
Bevacizumab, Oxaliplatin and 5-FU
Type of treatment
Surgery or procedure
How many people
25 participants
Where
2 sitesChina
Study dates
Mar 2012to Aug 2014
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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • ECOG status of 0 or 1.
  • All patients must have histologically confirmed adenocarcinoma of the rectum. The clinical stage must be T3, T4, or regional lymphnode involvement based on CT, MRI or EUS criteria. Criteria for pathologic enlargement of lymph nodes is > 15 mm on short axis dimension. If CT findings of lung, liver, or peritoneal metastases are equivocal, patients are eligible to participate.
  • All patients must have no distant metastatic disease on abdominopelvic CT scan performed with IV contrast.
  • The rectal tumor must be either palpable on digital rectal exam or the inferior edge of the tumor must be within 12 cm of the anal verge based on rigid proctoscopy.
  • Patients must have WBC > 4*10E9/L, ANC of > 1.5 *10E9/L, platelets > 100*10E9/L, Hemoglobin of > 90 g/L and adequate hepatic and renal function.
  • Patients must have signed informed consent indicating that they are aware of the investigational nature of the study, and are aware that participation is voluntary.

Who cannot join

  • Known compromised renal or hepatic function.
  • Participation in any other experimental drug study.
  • AST or ALT > 5 times upper limit of normal for subjects with documented liver metastases; > 2.5 times the upper limit of normal for subjects without evidence of liver metastases.
  • Pregnant or lactating woman. Woman of childbearing potential with either a positive or no pregnancy test at baseline. Woman/men of childbearing potential not using a reliable contraceptive method. (Postmenopausal woman must have been amenorrheic for at least 12 months to be considered of non-childbearing potential). Patients must agree to continue contraception for 30 days from the date of the last study drug administration.
  • Any prior chemotherapy.
  • Any prior radiation therapy.
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  • Serious, uncontrolled, concurrent infection(s) requiring IV antibiotics.
  • Treatment for other carcinomas within the last five years, except cure non-melanoma skin cancer and treated in-situ cervical cancer.
  • Clinically significant cardiac disease (e.g., uncontrolled hypertension [blood pressure of > 160/110 mmHg on medication], any history of myocardial infarction, unstable angina), New York Heart Association (NYHA) Grade II or greater congestive heart failure (see Appendix H), unstable symptomatic arrhythmia requiring medication (subjects with chronic atrial arrhythmia, i.e., atrial fibrillation or paroxysmal supraventricular tachycardia are eligible), or grade II or greater peripheral vascular disease(see Appendix H).
  • Evidence of bleeding diathesis or coagulopathy, INR greater than or equal to 1.5.
  • Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 0, or anticipation of need for major surgical procedure during the course of the study; fine needle aspirations or core biopsies within 7 days prior to Day 0.
  • Proteinuria at baseline or clinically significant impairment of renal function Subjects unexpectedly discovered to have 1+ proteinuria at baseline should undergo a 24-hour urine collection, which must be an adequate collection and must demonstrate < 500 mg of protein/24 hr to allow participation in the study.
  • Currently has serious, nonhealing wound, ulcer, or bone fracture.
  • Had aneurysms, strokes, transient ischemic attacks, and arteriovenous malformations within the past year.
  • Patients who have had an organ allograft.
  • Patients taking cimetidine must have this drug discontinued. Ranitidine or a drug from another anti-ulcer class can be substituted for cimetidine if necessary. If patient is currently receiving allopurinol, must discuss with PI to see of another agent may substitute for it.

Trial locations and contacts

2 sites in 1 country.

China2 sites

  • Sixth Affiliated Hospital of Sun Yat-sen University

    Guangzhou, Guangdong, 510600

  • Sixth Affiliated Hospital of Sun Yat-sen University

    Guangzhou, Guangdong, 510655

Other trials in China

About this study

Official title: Phase II Trial of Neoadjuvant Chemoradiation With Bevacizumab for Chinese Locally Advanced Rectal Adenocarcinoma

The purpose of the study is to evaluate the efficacy and safety of the combination of cytotoxic chemotherapy (Oxaliplatin and 5Fu) with bevacizumab concomitantly with radiotherapy as neoadjuvant treatment for patients with locally advanced but resectable rectal adenocarcinoma.

Read the detailed description

Primary endpoint: Pathological Complete Response Rate (pCR)

Secondary endpoint: Time to Relapse, disease free survival, overall survival and safety data

Being tested
Bevacizumab, Oxaliplatin, 5-FU, Radiotherapy
Keywords
Rectal cancer, Adenocarcinoma, Bevacizumab, Chemoradiation
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.

  • BevacizumabDrug

    Also called Avastin

    Bevacizumab 5mg/m2 D1,D15,D29,D43;

  • OxaliplatinDrug

    Oxaliplatin 85mg/m2 D1,D57; Oxaliplatin 85mg/m2 biweekly * 6 doses 3-4 weeks after radical resection

  • 5-FUDrug

    5-FU 2800mg/m2 civ 48 hours D1,D57; 5-FU 2800mg/m2 civ 48 hours biweekly*6 doses 3-4 weeks after radical resection; 5-FU 200mg/m2/day civ D15-19,D22-26,D29-33,D36-40,D43-47;

  • RadiotherapyRadiation

    2GY daily *20次

What is being measured

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

  1. Pathological complete response rate

    Measured: one year

Secondary outcomes (4)

  1. Time to progression

    Measured: one year

  2. Time to relapse

    Measured: one year

  3. Overall survival

    Measured: one year

  4. Safety data of this regimen

    Measured: one year

Timeline

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

  1. First posted14 Mar 2012 (estimated)
  2. Study startMar 2012
  3. Primary completionMay 2013
  4. Study completionAug 2014

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
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01554059
Sponsor's protocol ID
SAHMO-03
Acronym
New Beat
Status last verified
Nov 2014
First submitted
11 Mar 2012
Last updated
10 Nov 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • Xiao J, Chen Z, Li W, Yang Z, Huang Y, Zheng J, Deng Y, Wang L, Ren D, Peng J, Lan P, Wang J. Sandwich-like neoadjuvant therapy with bevacizumab for locally advanced rectal cancer: a phase II trial. Cancer Chemother Pharmacol. 2015 Jul;76(1):21-7. doi: 10.1007/s00280-015-2763-2. Epub 2015 May 8.

    PubMed 25952796

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Bevacizumab, Oxaliplatin and 5-FU in people with Rectal Adenocarcinoma, run by Sixth Affiliated Hospital, Sun Yat-sen University at 2 sites in China.

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 6 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 10 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. 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?

Pathological complete response rate (time frame: one year). 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 NCT01554059, 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 10 Nov 2014.

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