Preoperative Panitumumab and Radiotherapy in Rectal Cancer

Rectal Cancer Clinical Trial

— PrePaRad  

Official title:

Phase II Study of Preoperative Panitumumab and External Beam Radiotherapy in Patients With Locally Advanced Rectal Cancer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00973193
• Other study ID #: UCL-ONCO 09-001
• Secondary ID: Academic study
• Status: Terminated
• Phase: Phase 2
• First received: September 7, 2009
• Last updated: April 19, 2016
• Start date: September 2009
• Est. completion date: December 2012

Study information

• Verified date: April 2016
• Source: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health Products
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to investigate the activity of panitumumab in combination with standard preoperative radiotherapy in locally advanced rectal cancer, followed by complete surgery and adjuvant chemotherapy.

The main hypothesis of the study is that the association of EGFR-targeting agent and radiation therapy could be as effective or even improve the rate of pathological complete tumoral response with fewer toxicities in comparison to the standard of care using chemoradiation therapy.

Description:

Anti-EGFR monoclonal antibodies have radiosensitizing properties. In particular, cetuximab in combination with curative-intent radiotherapy has been reported to increase median overall survival over radiation therapy alone in locally advanced head and neck carcinoma.

Similar benefit in rectal cancer is expected. However, preliminary studies revealed that the combination of chemoradiation and cetuximab did not seem to improve the pathological tumor response. However, in the past studies, the selection of patients' population was not optimal since KRAS mutational status was not considered during recruitments.

Therefore, new trials to investigate EGFR-targeting therapies in combination with radiotherapy in wild-type KRAS patients are required.

Adjuvant chemotherapy has also shown to decrease the risk of local relapse in patients who did not receive chemotherapy during radiotherapy. In our study, since there will be no chemotherapy given during the preoperative setting, the administration of adjuvant chemotherapy postoperatively is highly recommended.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: December 2012
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• ECOG Performance Status 0-1

• Histologically proven adenocarcinoma of the rectum, T3-T4 and/or N+ M0

• Wild-type KRAS

• No prior pelvic irradiation

• Normal bone marrow, hepatic, renal, cardiac functions

• No secondary malignancy

• No other active, uncontrolled disease

• Signed informed consent

Exclusion Criteria:

• KRAS mutation

• Established or suspected metastasis

• Prior pelvic irradiation

• Previous exposure to EGFR-targeting therapies

• Patients under any other investigational agent(s)

• Concurrent systemic immune therapy, chemotherapy, hormone therapy

• Drug and/or alcohol abuse

• Grade 3 to 4 allergic reaction to any of the components of the treatment

• History or presence of interstitial lung disease

• Active, uncontrolled cardiovascular disease

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms

Intervention

Drug:
• panitumumab
intravenous infusion of panitumumab, 6 mg per kg body weight, once every 14 days for a total of 42 days

Locations

Country	Name	City	State
Belgium	Cliniques Universitaires Saint Luc - Université Catholique de Louvain	Brussels
Belgium	Institute Jules Bordet	Brussels
Belgium	Centre Hospitalier Notre Dame et Reine Fabiola	Charleroi
Belgium	Centre Hospitalier de Jolimont-Lobbes	La Louvière
Belgium	UZ Gasthuisberg	Leuven
Belgium	Clinique et Maternité Saint Elizabeth	Namur
Belgium	Clinique Saint Pierre	Ottignies
Belgium	Clinique Universitaire de Mont Godinne	Yvoir

Sponsors (1)

Lead Sponsor	Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pathological Complete Response (pCR)		11 weeks	No
Secondary	Safety, pathologic R0 resection, negative Circumferential Resection Margin, pathologic downstaging, tumor regression grade, quality of mesorectal excision, rate of sphincter-preservation, Disease-Free Survival, local control rate, translational research		24 months	Yes