Neoadjuvant radiotherapy and capecitabine with or without panitumumab in patients with advanced, K-ras unmutated rectal cancer. A randomized multicenter phase II trial.

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2008-006012-38-HU
• Date of registration: 27/10/2010
• Prospective Registration: No
• Primary sponsor: SAKK (Swiss Group for Clinical Cancer Research)
• Public title: Neoadjuvant radiotherapy and capecitabine with or without panitumumab in patients with advanced, K-ras unmutated rectal cancer. A randomized multicenter phase II trial.
• Scientific title: Neoadjuvant radiotherapy and capecitabine with or without panitumumab in patients with advanced, K-ras unmutated rectal cancer. A randomized multicenter phase II trial.
• Date of first enrolment: 04/08/2009
• Target sample size: 67
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-006012-38
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: yes Other specify the comparator: with or without Panitumumab

Countries of recruitment

Hungary

Key inclusion & exclusion criteria

Inclusion criteria:
- Histologically confirmed advanced adenocarcinoma of the rectum with or without nodal involvement requiring surgery, stage mrT 3/4 and/or mrN 1/2 cM0.
- Tumors with the wild type K-ras gene
- Patient is considered operable
- Age >= 18 years
- Adequate hematological values
- Adequate renal and hepatic function
- Women are not breastfeeding, are using contraception if sexually active, are not pregnant
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
- Previous malignancy within 5 years (with exception of adequately treated cervical carcinoma or localized non-melanoma skin cancer)
- Distant metastasis
- Concurrent treatment with other experimental drugs or other anti-cancer therapy
- Any prior treatment for rectal cancer
- Prior anti-EGFR antibody therapy or treatment with small molecule EGFR inhibitors
- Pre-existing condition which would preclude radiotherapy
- Organ allografts
- Any concomitant drugs contraindicated for use with the trial drugs


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Advanced K-ras unmutated rectal cancer.

Intervention(s)

Trade Name: VECTIBIX
Product Name: VECTIBIX
Pharmaceutical Form: Concentrate for solution for infusion

Primary Outcome(s)

Primary end point(s): Pathological near complete or complete response (Dworak grade 3 and 4)

Secondary Objective: The objective of the molecular correlates part is the comparison of two techniques for the assessment of the K-ras mutation status.

Main Objective: To assess the efficacy and safety of the neoadjuvant regimen of capecitabine and external beam radiotherapy in combination with panitumumab in patients with advanced K-ras unmutated rectal cancer.

Secondary ID(s)

SAKK 41/07