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| ID | Type | Description | Link |
|---|---|---|---|
| SWS-SAKK-41-07 | |||
| EudraCT-2008-006012-38 | |||
| EU-20894 | |||
| CDR0000629101 |
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RATIONALE: Drugs used in chemotherapy, such as capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy that uses a 3-dimensional (3-D) image of the tumor to help focus thin beams of radiation directly on the tumor, and giving radiation therapy in higher doses over a shorter period of time, may kill more tumor cells and have fewer side effects. Monoclonal antibodies, such as panitumumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether giving capecitabine together with 3-D conformal radiation therapy is more effective with or without panitumumab in treating patients with advanced rectal cancer.
PURPOSE: This randomized phase II trial is studying giving capecitabine together with radiation therapy to see how well it works with or without panitumumab in treating patients with advanced rectal cancer.
OBJECTIVES:
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.
After completion of study therapy, patients are followed periodically for up to 3 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I | Experimental | 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 | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| panitumumab | Biological | Given IV |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Pathological complete or near-complete response (Dworak grade 3 and 4) | after 13 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Pathological response | after 13 weeks. | |
| R0 or R1 resection | after 13 weeks. | |
| Postoperative complications (within 8 weeks after surgery) |
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DISEASE CHARACTERISTICS:
Histologically confirmed advanced adenocarcinoma of the rectum with or without nodal involvement
No distant metastasis
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Helbling, MD | Onkozentrum Zürich | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Szent Laszlo Korhaz | Budapest | 1097 | Hungary | |||
| Hirslanden Klinik Aarau |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23139259 | Result | Helbling D, Bodoky G, Gautschi O, Sun H, Bosman F, Gloor B, Burkhard R, Winterhalder R, Madlung A, Rauch D, Saletti P, Widmer L, Borner M, Baertschi D, Yan P, Benhattar J, Leibundgut EO, Bougel S, Koeberle D. Neoadjuvant chemoradiotherapy with or without panitumumab in patients with wild-type KRAS, locally advanced rectal cancer (LARC): a randomized, multicenter, phase II trial SAKK 41/07. Ann Oncol. 2013 Mar;24(3):718-25. doi: 10.1093/annonc/mds519. Epub 2012 Nov 8. |
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| capecitabine |
| Drug |
Given orally |
|
|
| therapeutic conventional surgery | Procedure | Patients undergo surgical resection |
|
| 3-dimensional conformal radiation therapy | Radiation | Patients undergo radiotherapy |
|
| within 8 weeks after surgery |
| Time to local relapse | calculated from randomization to documented relapse or censored at the last CT and/or endorectal ultrasound without local relapse. |
| Time to distant failure | calculated from randomization to documented distant (metastatic) failure or censored at the last CT without distant (metastatic) failure. |
| Disease-free survival | calculated from randomization to first relapse or death (whichever occurs first). |
| Adverse events | All AEs will be assessed according to NCI CTCAE v3.0. |
| Aarau |
| CH-5001 |
| Switzerland |
| Kantonspital Aarau | Aarau | CH-5001 | Switzerland |
| Kantonsspital Baden | Baden | CH-5404 | Switzerland |
| Saint Claraspital AG | Basel | CH-4016 | Switzerland |
| Universitaetsspital-Basel | Basel | CH-4031 | Switzerland |
| Istituto Oncologico della Svizzera Italiana | Bellinzona | 6500 | Switzerland |
| Inselspital Bern | Bern | CH-3010 | Switzerland |
| Spitalzentrum Biel | Biel | CH-2501 | Switzerland |
| Kantonsspital Bruderholz | Bruderholz | CH-4101 | Switzerland |
| Kantonsspital Graubuenden | Chur | CH-7000 | Switzerland |
| Hopital Cantonal Universitaire de Geneve | Geneva | CH-1211 | Switzerland |
| Centre Hospitalier Universitaire Vaudois | Lausanne | CH-1011 | Switzerland |
| OnkoZentrum Luzern at Klinik St. Anna | Lucerne | 6006 | Switzerland |
| Kantonsspital, Luzerne | Luzerne | CH-6000 | Switzerland |
| Kantonsspital Olten | Olten | CH-4600 | Switzerland |
| Kantonsspital - St. Gallen | Sankt Gallen | CH-9007 | Switzerland |
| Hopital Regional de Sion-Herens-Conthey | Sion | CH -1951 | Switzerland |
| Regionalspital | Thun | 3600 | Switzerland |
| Kantonsspital Winterthur | Winterthur | CH-8400 | Switzerland |
| Onkozentrum | Zurich | 8038 | Switzerland |
| Klinik Hirslanden | Zurich | CH-8032 | Switzerland |
| City Hospital Triemli | Zurich | CH-8063 | Switzerland |
| UniversitaetsSpital Zuerich | Zurich | CH-8091 | Switzerland |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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| ID | Term |
|---|---|
| D000077544 | Panitumumab |
| D000069287 | Capecitabine |
| D020266 | Radiotherapy, Conformal |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D011881 | Radiotherapy, Computer-Assisted |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
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