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Rectal CancerPhase 2NEOREC-1NCT01443377

Neoadjuvant Radiochemotherapy Combined With Panitumumab in Locally Advanced KRAS Wild-type Rectal Cancer

A Phase 2 study testing Panitumumab in people with Rectal Cancer, run by National Center for Tumor Diseases, Heidelberg at 2 sites 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

This study aims to investigate the combination of panitumumab and a 5-FU-based RCTX in patients with locally advanced KRAS wild-type 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?
Panitumumab
Type of treatment
Injection or infusion
How many people
48 participants
Where
2 sitesGermany
Study dates
Jul 2011to Sep 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

  • Histologically confirmed, potentially resectable rectal adenocarcinoma staged as uT3/4 N0/1 by endosonography or cT3/4 by MRI of the pelvis with or without local lymph node metastases.
  • Wild-type KRAS.
  • ECOG-performance status 0 or 1.
  • Age ≥ 18 years.
  • Laboratory requirements:
  • Haematology: Leucocyte count > 3,000/mm³, neutrophil count ≥1.5x109/L, hemoglobin ≥ 8 g/dL, platelet count ≥100x109/L.
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  • Hepatic Function: Total bilirubin ≤ 1.5 time the upper normal limit (UNL), ASAT ≤ 2.5xUNL in absence of liver metastases or ≤ 5xUNL in presence of liver metastases, ALAT ≤ 2.5xUNL in absence of liver metastases or ≤ 5xUNL in presence of liver metastases
  • Renal Function: Creatinine clearance ≥50 mL/min or serum creatinine ≤1.5xUNL
  • Metabolic Function: Magnesium ≥ lower limit of normal, Calcium ≥ lower limit of normal.
  • Negative ß-HCG-serum pregnancy test (females of child bearing potential).
  • Willing to use double-barrier contraception during study and for 6 months after the end of treatment.
  • Ability of patient to understand character and individual consequences of clinical trial
  • Written informed consent (must be available before enrollment in the trial)

Who cannot join

  • Prior EGFR targeting or prior chemo- or radiotherapy or tumor surgery.
  • Evidence of any distant metastases.
  • Manifest or previous secondary malignancies within the last 5 years.
  • Uncontrolled infection.
  • Clinically significant cardiovascular disease NYHA classification III or IV (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) ≤ 1 year before enrollment/randomization.
  • History of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on screening chest CT scan.
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  • Diabetes mellitus
  • Subject pregnant or breast feeding, or planning to become pregnant within 6 month after the end of treatment.
  • Subject (male or female) is not willing to use highly effective methods of contraception (per institutional standard) during treatment and for 6 months (male or female) after the end of treatment.
  • Active serious illness which renders the patient unsuitable for study entrance, multiple blood sampling or the above mentioned biopsies.
  • History of hypersensitivity to the investigational medicinal product or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational medicinal product.
  • Participation in other clinical trials or observation period of competing trials, respectively.

Trial locations and contacts

2 sites in 1 country.

Germany2 sites

  • Krankenhaus Nord West, Radioonkologische Klinik

    Frankfurt am Main, Hesse, 60488

  • National Center for Tumor Disease (NCT)

    Heidelberg, Baden-Wurttemberg, 69120

Other trials in Germany

About this study

This study aims to investigate the combination of panitumumab and a 5-FU-based RCTX in patients with locally advanced KRAS wild-type rectal cancer.

Read the detailed description

Significant progress in the management of locally advanced rectal cancer has been achieved during the last decade. This includes surgical techniques as the widespread implementation of total mesorectal excision as well as preoperative radiochemotherapy (RCTX). The results of the recent randomized trials led to a current standard in which most (radio-) oncologists now use continuous-infusion 5-FU concomitantly with preoperative radiotherapy. It has been demonstrated that this provides improved tumor downstaging and local control; however, no significant differences have yet been achieved in the 5-year disease-free and overall survival rates.

Thus, the challenge is to integrate more effective systemic therapy into the combined-modality programs. The combination of RCTX with novel chemotherapeutic agents like oxaliplatin and irinotecan in phase I/II trials suggested higher rates of histopathological complete remission (pCR) compared with 5-FU RCTX alone. However, due to the lack of results from randomized trials, to date no improvement of the long-term outcomes could be demonstrated, moreover, for some studies the increased pCR rate was associated with an increase in toxicity.

Another strategy to improve outcome is to incorporate newer, biologically active, targeted therapies into established RCTX regimens. Because of its key role in signalling proliferation, inhibition of apoptosis and angiogenesis the epidermal growth factor receptor (EGFR) is a promising target of antitumor treatment. To date a few clinical phase I/II studies of preoperative RCTX have been initiated to evaluate EGFR inhibitors as radiosensitizer in rectal cancer. These trials demonstrated that a combination of cetuximab and RCTX could be safely applied without dose compromises of the respective treatment components. However, the pCR rates could not be improved in these studies.

Given the strong preclinical rationale to combine EGFR inhibition with RCTX in rectal cancer patients, this study aims to investigate the combination of panitumumab and a 5-FU-based RCTX in patients with locally advanced KRAS wild-type rectal cancer.

Conditions
Rectal Cancer
Being tested
Panitumumab
Keywords
Neorec, rectal cancer, KRAS, Panitumumab, neoadjuvant, Radiochemotherapy, antibody, locally advanced KRAS wild type rectal cancer
Medical subject headings
Rectal Neoplasms

What participants receive

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

  • PanitumumabBiological

    Also called Vectibix®

    Intravenous (IV), Panitumumab 6 mg/kg BW q2w d1-d57 (5 times total); begin on day 1 (run-in-phase) and subsequent application on days 15, 29 43 and 57.

What is being measured

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

  1. Histopathological complete response rate (pCR)

    pCR determined by means of the resection specimens

    Measured: at week 14 after tumor resection

Secondary outcomes (7)

  1. Objective tumor response rate assessed by MRI of the pelvis (incl. RECIST)

    Measured: at day 14 and week 12

  2. Metabolic tumor response rate assessed by means of changes in the standardized uptake values (SUV) using FDG-PET-CT (incl. RECIST)

    Measured: day 14 and at week 14 before surgery

  3. Pathological tumor regression grades will be classified according to Becker

    Measured: at week 14 after surgery

  4. Quality of Life (QoL) will be assessed using the EORTC QLQ-C30 in combination with the colorectal cancer-specific quality of life questionaire module (QLQ-CR29)

    Measured: between day 0 and week 18 end of study

  5. distant metastases-free survival

    distant metastases-free survival after EOS

    Measured: during follow up every 6 months until death or until 2 years after LPO

  6. relapse-free survival

    relapse-free survival after end of study

    Measured: during follow up every 6 months until death or until 2 years after LPO

  7. overall survival

    overall survival after EOS

    Measured: during follow up every 6 months until death or until 2 years after LPO

Timeline

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

  1. First posted29 Sep 2011 (estimated)
  2. Study startJul 2011
  3. Primary completionSep 2012
  4. Study completionSep 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
48 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01443377
Sponsor's protocol ID
NCT-0001021
Acronym
NEOREC-1
Status last verified
Apr 2012
First submitted
23 Aug 2011
Last updated
7 May 2015
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Panitumumab in people with Rectal Cancer, run by National Center for Tumor Diseases, Heidelberg at 2 sites 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 13 inclusion and 12 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 7 May 2015. 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 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 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?

Histopathological complete response rate (pCR) (time frame: at week 14 after tumor resection). 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 NCT01443377.

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 7 May 2015.

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