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Advanced Gastric CancerPhase 3AIO-STO-0111NCT01248403

A Randomized, Double Blind Study Evaluating Paclitaxel With and Without RAD001 in Patients With Gastric Carcinoma After Prior Chemotherapy

A Phase 3 study testing Paclitaxel and RAD001 in people with Advanced Gastric Cancer and Esophagogastric Junction Cancer, run by Krankenhaus Nordwest at 1 site in Germany.

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

Adult patients with gastric carcinoma which has progressed after initial treatment with a fluoropyrimidines-containing regimen will be treated with paclitaxel plus RAD001 or plus placebo. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Paclitaxel and RAD001
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
1 siteGermany
Study dates
Oct 2011to Oct 2019
Phase
Phase 3
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

  • Male or female patients ≥ 18 years old
  • Histologically or cytologically confirmed and documented gastric adenocarcinoma. Adenocarcinomata of the gastro-esophageal junction will be allowed, if they have advanced disease (inoperable, recurrent or metastatic disease).
  • Documented progressive disease during/after one, two or three prior treatments containing 5FU and/or its precursors or derivatives in the palliative setting
  • At least one measurable or evaluable lesion by RECIST as determined by Computed Tomography (CT) Scan or Magnetic Resonance Imaging (MRI)
  • ECOG performance status of 0, 1 or 2
  • The following laboratory parameters:
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  • Absolute neutrophil count ≥ 1.5 x 109/L
  • Platelets ≥ 100 x 109/L
  • Hemoglobin (Hgb) ≥ 9 g/dL
  • Serum creatinine ≤ 2 x Upper Limit of Normal (ULN)
  • Adequate liver function:
  • Total serum calcium (corrected for serum albumin) or ionized calcium ≥ LLN
  • Women of childbearing potential must have a negative serum pregnancy test within 7 days of the first administration of study treatments and must be willing to use adequate methods of contraception during the study and for 3 months after last study drug administration.
  • Written informed consent

Who cannot join

  • Current treatment with any anti cancer therapy or treatment with anti cancer therapy ≤ 2 weeks prior to study treatment start unless rapidly progressing disease is measured
  • Known hypersensitivity to RAD001 (everolimus) or to its excipients, or to other rapamycins (e.g. sirolimus, temsirolimus)
  • Known prior history of hypersensitivity to paclitaxel.
  • Paclitaxel refractory disease, which is defined as a disease progression under or within 12 weeks of last taxan treatment
  • Chronic treatment with steroids (except for oral, topical or local injection) or another immunosuppressive agent
  • Major surgery ≤ 2 weeks prior to starting study treatment or patients who have not recovered from such therapy
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  • Lack of resolution of all acute toxic effects (excluding alopecia) of prior chemotherapy, prior radiotherapy, or surgical procedure to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grade <= 1. Note: Neuropathy due to prior chemotherapy is allowed.
  • Unstable CNS disease
  • Requiring increasing doses of steroids to maintain stable neurological status
  • Deteriorating / changing neurological status
  • Known history of HIV seropositivity (HIV testing is not mandatory) or Hepatitis B or C.
  • Active, bleeding diathesis or on oral anti-vitamin K medication (except low dose warfarin, as long as the INR is <= 2.0)
  • Any other severe and/or uncontrolled medical conditions

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Krankenhaus Nordwest

    Frankfurt am Main, 60488

Other trials in Germany

About this study

Official title: A Randomized, Double-blind, Multi-center Phase III Study Evaluating Paclitaxel With and Without RAD001 in Patients With Gastric Carcinoma Who Have Progressed After Therapy With a Fluoropyrimidine-containing Regimen

Adult patients with gastric carcinoma which has progressed after initial treatment with a fluoropyrimidines-containing regimen will be treated with paclitaxel plus RAD001 or plus placebo. The hypothesis is that patients with RAD001 have significantly prolonged overall survival compared to patients who are treated with paclitaxel alone.

Read the detailed description

This is a randomized, double-blind, phase III two-arm multi-center study aiming at estimating the relative efficacy of the combination of RAD001 and paclitaxel versus that of paclitaxel alone as second-, third- or fourth-line treatment in terms of hazard ratio of overall survival in patients with gastric cancer who have relapsed after one treatment regimen containing a fluoropyrimidine (e.g., 5-FU, S-1, capecitabine and other 5-FU prodrugs or derivatives). Patients will be randomized in a 1:1 ratio for a total of 240 patients per treatment arm. Randomization will be stratified according to performance status (0-1 versus 2), prior taxan use (yes vs. no) and treatment line (2nd versus 3rd/4th line).

Study treatment will be continued until progression or intolerable toxicity. Patients will be seen at baseline/screening, and weekly for paclitaxel administration and safety assessment until disease progression or discontinuation of trial therapy for other reasons. Radiological tumor assessment will be performed every second cycle (every 8 weeks) or earlier if clinically indicated. Post-study follow-up will be completed every 8 weeks for survival.

Being tested
Paclitaxel, RAD001
Keywords
RAD001, Paclitaxel, gastric cancer, advanced gastric or esophagogastric junction cancer
Medical subject headings
Stomach Neoplasms

What participants receive

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

  • PaclitaxelDrug

    Paclitaxel 80 mg/m2 on day 1, day 8 and day 15 of every 28-day cycle.

  • RAD001Drug

    Also called Everolimus, Certican

    RAD001 10mg (2 x5 mg tablets / day) d1-d28

Study groups in NCT01248403
Study groupRoleWhat they receive
paclitaxel + placeboActive comparatorPaclitaxel 80 mg/m2 on day 1, day 8 and day 15 of every 28-day cycle. + Placebo (2 tablets / day) d1-d28
Receives: Drug: Paclitaxel
paclitaxel + RAD001ExperimentalPaclitaxel 80 mg/m2 on day 1, day 8 and day 15 of every 28-day cycle. + RAD001 10mg (2 x5 mg tablets / day) d1-d28
Receives: Drug: Paclitaxel; Drug: RAD001

What is being measured

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

  1. overall survival

    Measured: 6 months follow-up

Secondary outcomes (4)

  1. best overall response

    Measured: staging every 8 weeks

  2. progression-free survival

    Measured: staging every 8 weeks

  3. number of participants with adverse events as a measure of safety and tolerability

    Measured: every week until end of treatment

  4. disease control rate

    responders + stable disease ≥12 weeks

    Measured: every 8 weeks

Timeline

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

  1. First posted25 Nov 2010 (estimated)
  2. Study startOct 2011
  3. Primary completionJul 2017
  4. Study completionOct 2019

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
300 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01248403
Sponsor's protocol ID
CRAD001RDE35T
Acronym
AIO-STO-0111
Status last verified
Jan 2020
First submitted
23 Nov 2010
Last updated
29 Jan 2020
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No: No IPD will be shared.

Publications

  • Lorenzen S, Knorrenschild JR, Pauligk C, Hegewisch-Becker S, Seraphin J, Thuss-Patience P, Kopp HG, Dechow T, Vogel A, Luley KB, Pink D, Stahl M, Kullmann F, Hebart H, Siveke J, Egger M, Homann N, Probst S, Goetze TO, Al-Batran SE. Phase III randomized, double-blind study of paclitaxel with and without everolimus in patients with advanced gastric or esophagogastric junction carcinoma who have progressed after therapy with a fluoropyrimidine/platinum-containing regimen (RADPAC). Int J Cancer. 2020 Nov 1;147(9):2493-2502. doi: 10.1002/ijc.33025. Epub 2020 May 7.

    PubMed 32339253

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Paclitaxel and RAD001 in people with Advanced Gastric Cancer and Esophagogastric Junction Cancer, run by Krankenhaus Nordwest at 1 site in Germany.

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 13 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 Jan 2020. 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 Germany. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

overall survival (time frame: 6 months follow-up). 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 NCT01248403, 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 Jan 2020; AzTrials last refreshed its copy on 4 Nov 2026.

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