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Rectal CancerPhase 2NEO-RITNCT01257360

Panitumumab in Combination With Radiotherapy in Patients With Locally Advanced RAS Wildtype Rectal Cancer (Clinical Stages II and III)

A Phase 2 study testing Panitumumab and Radiation of the pelvis in people with Rectal Cancer, run by WiSP Wissenschaftlicher Service Pharma GmbH at 5 sites in Germany.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The objective of this trial is to obtain evidence that, in patients with RAS wildtype tumors, a chemotherapy-free combined modality treatment with panitumumab is clearly superior to radiotherapy alone and achieves a pCR rate comparable to that after radiochemotherapy including two-drug combinations while reducing the… 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 and Radiation of the pelvis
How many people
59 participants
Where
5 sitesGermany
Study dates
Dec 2010to Jul 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

  • Histologically confirmed diagnosis of locally advanced rectal cancer (stage II or III) localised 0 - 12 cm ab ano as measured by rigid rectoscopy (i.e. lower and middle third of the rectum)
  • Staging requirements: trans-rectal endoscopic ultrasound (EUS) and magnetic resonance imaging (MRI)
  • Sufficient representative sample material for RAS analysis
  • Wild-type RAS (determined by an accredited local laboratory, if not available by pathology of Mannheim university)
  • RAS wild-type tested in
  • KRAS exon 2 (codons 12/13)
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  • KRAS exon 3 (codons 59/61)
  • KRAS exon 4 (codons 117/146)
  • NRAS exon 2 (codons 12/13)
  • NRAS exon 3 (codons 59/61)
  • NRAS exon 4 (codons 117/146)
  • Informed consent of the patient
  • Aged at least 18 years
  • WHO Performance Status 0-2
  • Life expectancy of al least 12 weeks
  • Adequate haematological, hepatic, renal and metabolic function parameters:
  • Leukocytes > 3000/mm³
  • ANC ≥ 1500/mm³
  • Platelets ≥ 100,000/mm³
  • Hb > 9 g/dl
  • Creatinine clearance ≥ 50 ml/min and serum creatinine ≤ 1.5 x upper limit of normal
  • Bilirubin ≤ 1.5 x upper limit of normal
  • GOT-GPT ≤ 2.5 x upper limit of normal
  • AP ≤ 5 x upper limit of normal
  • Magnesium ≥ lower limit of normal
  • Calcium ≥ lower limit of normal

Who cannot join

  • Lower border of the tumor localised more than 12 cm ab ano as measured by rigid rectoscopy
  • Distant metastases (to be excluded by CT scan of the thorax and abdomen)
  • cT4 tumor (as determined by MRI and/or endorectal ultrasound)
  • Risk of tumor involvement of the circumferential resection margin, according to the MRI assessment
  • Sphincter sparing is the major reason for choosing the neoadjuvant treatment approach
  • Prior antineoplastic therapy for rectal cancer
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  • Prior radiotherapy of the pelvic region
  • Major surgery within the last 4 weeks prior to inclusion
  • Subject pregnant or breast feeding, or planning to become pregnant within 6 months 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 (adequate: oral contraceptives, intrauterine device or barrier method in conjunction with spermicidal jelly)
  • Serious concurrent diseases
  • On-treatment participation in a clinical study in the period 30 days prior to inclusion
  • Clinically significant cardiovascular disease in (incl. myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) ≤ 1 year before enrolment
  • History of interstitial lung disease, e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan
  • History of HIV infection
  • Prior or concurrent malignancy (≤ 5 years prior to enrolment in study) except non-melanoma skin cancer or cervical carcinoma FIGO stage 0-1 if the patient is continuously disease-free
  • Known allergic reactions on study medication

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Germany5 sites

  • Klinikum Esslingen Klinik für Onkologie, Gastroenterologie und Allgemeine Innere Medizin

    Esslingen am Neckar, 73780

  • Klinik für Strahlentherapie und Onkologie, Universitätsklinikum Frankfurt am Main

    Frankfurt am Main, 60590

  • SLK-Kliniken Heilbronn GmbH Medizinische Klinik III

    Heilbronn, 74078

  • Tagestherapiezentrum am ITM & III. Medizinische Klinik, Universitätsmedizin Mannheim

    Mannheim, 68167

  • Prosper Hospital Medizinische Klinik I

    Recklinghausen, 45659

Other trials in Germany

About this study

Official title: NEO-RIT - Panitumumab in Combination With Radiotherapy in Patients With Locally Advanced RAS Wildtype Rectal Cancer (Clinical Stages II and III)

The objective of this trial is to obtain evidence that, in patients with RAS wildtype tumors, a chemotherapy-free combined modality treatment with panitumumab is clearly superior to radiotherapy alone and achieves a pCR rate comparable to that after radiochemotherapy including two-drug combinations while reducing the toxicity compared to these two-drug regimens.

Conditions
Rectal Cancer
Being tested
Panitumumab, Radiation of the pelvis
Keywords
RAS-Wildtype, Radiotherapy, Neoadjuvant treatment
Medical subject headings
Rectal Neoplasms

What participants receive

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

  • PanitumumabDrug

    Also called Vectibix

    Panitumumab 6 mg/kg BW will be administered IV every 2 weeks (q2w) on day -14, 1, 15, 29 (and 43, in case radiotherapy is still ongoing due to delays) of the radiotherapy.

  • Radiation of the pelvisRadiation

    Radiation is applied at single doses of 1.8 Gy at the ICRU 50 reference point, once daily, five times a week, adding up to 28 fractions over almost 6 weeks and a total reference dose of 50.4 Gy.

What is being measured

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

  1. Rate of pathological complete remissions

    The rate of pathological complete remissions is determined after tumor resection following neoadjuvant treatment.

    Measured: 15 weeks (average) after start of treatment (at surgery)

Secondary outcomes (6)

  1. Toxicity according to NCI CTCAE

  2. Frequency of surgical morbidity and complications

    Measured: Within four weeks after surgery

  3. pTNM findings in relation to initial cTNM staging

    Measured: At surgery

  4. Regression grading according to Dworak

    Measured: At surgery

  5. Clinical response rates (CR/PR/SD/PD) after neoadjuvant treatment

    Measured: Before surgery

  6. Correlative biomarker analyses

Timeline

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

  1. First posted9 Dec 2010 (estimated)
  2. Study startDec 2010
  3. Primary completionJan 2016
  4. Study completionJul 2016 (estimated)

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
59 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01257360
Sponsor's protocol ID
WISP_AG52
Other IDs
2009-016782-28, GMIHO 009/2009, 2009
Acronym
NEO-RIT
Status last verified
Jan 2016
First submitted
1 Dec 2010
Last updated
13 Jan 2016
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Panitumumab and Radiation of the pelvis in people with Rectal Cancer, run by WiSP Wissenschaftlicher Service Pharma GmbH at 5 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 26 inclusion and 17 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: status not confirmed, as of the sponsor's last update on 13 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 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?

Results are not available in the source record.

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 of pathological complete remissions (time frame: 15 weeks (average) after start of treatment (at surgery)). 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 NCT01257360.

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 13 Jan 2016.

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