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Neoadjuvant Radiotherapy and Capecitabine With or Without Panitumumab in Patients With Advanced, K-ras Unmutated Rectal Cancer. A Randomized Multicenter Phase II Trial

Phase 2
18 Years
Open (Enrolling)
Colorectal Cancer

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Trial Information

Neoadjuvant Radiotherapy and Capecitabine With or Without Panitumumab in Patients With Advanced, K-ras Unmutated Rectal Cancer. A Randomized Multicenter Phase II Trial


- To assess the efficacy and safety of neoadjuvant capecitabine and concurrent
3-dimensional conformal radiotherapy with vs without panitumumab in patients with
advanced K-ras unmutated rectal cancer.

OUTLINE: This is a multicenter study. Patients are stratified according to participating
center, T stage (T3 vs T4), tumor localization measured from caudal part of the tumor to the
anocutaneous line (< 10 cm vs ≥ 10 cm), and number of EGFR gene copies (< 2.9 vs ≥ 2.9).
Patients are randomized to 1 of 2 treatment arms.

- Arm I: Patients receive panitumumab IV over 30-90 minutes on days 1, 15, 29, 43, and 57
and oral capecitabine twice daily on days 8-40. Beginning on day 8, patients undergo
daily fractions of 3-D conformal radiotherapy 5 days a week for 5 weeks. Beginning
approximately 6 weeks after completion of panitumumab and chemoradiotherapy, patients
undergo surgery.

- Arm II: Patients receive oral capecitabine twice daily on days 1-33. Patients undergo
concurrent 3-D conformal radiotherapy 5 days a week for 5 weeks. Beginning 6 weeks
after completion of chemoradiotherapy, patients undergo surgery.

After completion of study therapy, patients are followed periodically for up to 3 years.

Inclusion Criteria


- Histologically confirmed advanced adenocarcinoma of the rectum with or without nodal

- Stage mrT3-4 and/or mrN1-2, M0

- Tumors must express wild type K-ras gene

- No distant metastasis


- WHO performance status 0-1

- Able to undergo surgery

- ANC ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

- Hemoglobin ≥ 100 g/L

- Creatinine clearance ≥ 50 mL/min

- AST ≤ 2.5 times upper limit normal (ULN)

- Total bilirubin ≤ 1.5 times ULN

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must agree to use effective contraception during and for 12 months
after completion of study

- No malignancy within the past 5 years with the exception of adequately treated
cervical carcinoma in situ or localized nonmelanoma skin cancer

- No psychiatric disorder that would preclude understanding study-related information,
giving informed consent, or complying with oral drug intake

- No prior existing conditions that would preclude radiotherapy

- No clinically significant (i.e., active) cardiac disease (e.g., congestive heart
failure, symptomatic coronary artery disease, and cardiac arrhythmia even if
controlled with medication) or myocardial infarction within the past 12 months

- No lack of physical integrity of the upper gastrointestinal tract or malabsorption

- No serious underlying medical condition that, in the judgement of the investigator,
could impair the ability of the patient to participate in the trial (e.g., active
autoimmune disease or uncontrolled diabetes)

- No known dihydropyrimidine dehydrogenase deficiency

- No known hypersensitivity to trial drugs or hypersensitivity to any other component
of the trial drugs


- More than 30 days since prior treatment in a clinical trial

- No other concurrent experimental drugs, anticancer therapy, or investigational

- No prior treatment for rectal cancer

- No prior anti-EGFR antibody therapy (e.g., cetuximab) or small-molecule EGFR
inhibitors (e.g., erlotinib hydrochloride)

- No concurrent treatment with brivudine, lamivudine, ribavirin, or any other
nucleoside analogues

- No organ allografts

- No concurrent drugs contraindicated for use with the trial drugs

- No other concurrent anti-EGFR-targeting agents

- No other concurrent radiotherapy

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Pathological complete or near-complete response (Dworak grade 3 and 4)

Outcome Time Frame:

after 13 weeks.

Safety Issue:


Principal Investigator

Daniel Helbling, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Onkozentrum Zürich


Switzerland: Swissmedic

Study ID:

SAKK 41/07



Start Date:

November 2008

Completion Date:

December 2013

Related Keywords:

  • Colorectal Cancer
  • adenocarcinoma of the rectum
  • stage III rectal cancer
  • stage II rectal cancer
  • Rectal Neoplasms
  • Colorectal Neoplasms