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| 0514
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| Number: | RTOG 0514 |
| Title: | Establishment Of A Head And Neck Cancer Tissue/Specimen Bank |
| Eligibility: |
Patients must have a suspected or confirmed diagnosis of head and neck cancer and must be potentially eligible for an active RTOG treatment study. Patients with biopsy proven recurrent cancer at the primary site also are eligible if they are potentially eligible for an RTOG treatment study for patients with recurrent disease or if they fail on an RTOG treatment study which collects specimens at the time of recurrence. Zubrod Performance Status 0-1; Age > 18; Patient must sign a study specific informed consent for RTOG 0514 prior to submission of specimens.
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| Study size: | N/A, Ongoing Prospective Tissue/Specimen Bank Research Study |
| 0522
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|---|
| Number: | RTOG 0522 |
| Title: | A Randomized Phase III Trial of Concurrent Accelerated Radiation and Cisplatin Versus Concurrent Accelerated Radiation, Cisplatin, and Cetuximab (C225) [Followed by Surgery for Selected Patients] for Stage III and IV Head and Neck Carcinomas |
| Eligibility: |
Histologically proven (from primary lesion and/or lymph nodes) diagnosis of squamous cell carcinoma of the oropharynx, hypopharynx, or larynx; Selected stage III or IV disease (T2N2-3M0, T3-4 any N M0); no distant metastases; Zubrod Performance Status 0-1; Age > 18; Adequate bone marrow, hepatic, and renal function as specified; Women of childbearing potential and male participants must agree to use a medically effective means of birth control throughout their participation in the treatment phase of the study (until at least 60 days following the last study treatment); Patient must sign study specific informed consent prior to study entry. No prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years; No prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable; No prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields; No primary site of tumor of oral cavity, nasopharynx, sinuses, or salivary glands; No initial surgical treatment, excluding diagnostic biopsy of the primary site or nodal sampling of neck disease; radical or modified neck dissection is not permitted. No severe, active co-morbidity; No CTCAE, v. 3.0 grade 3-4 electrolyte abnormalities; No pregnant or lactating women; No prior allergic reaction to the study drug(s) involved in this protocol; No prior therapy that specifically and directly targets the EGFR pathway.
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| Treatment |
Arm 1: Accelerated Fractionation by Concomitant Boost (AFX-CB) or IMRT plus cisplatin
Arm 2: Accelerated Fractionation by Concomitant Boost(AFX-CB) or IMRT plus cisplatin; plus cetuximab
8-9 Weeks Post-Treatment Reassessment
Selected Patients: Required Neck Dissection
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| Study size: | 720 |
| 0615
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|---|
| Number: | RTOG 0615 |
| Title: |
A Phase II Study of Concurrent Chemoradiotherapy Using Three-Dimensional Conformal Radiotherapy (3D-CRT) or Intensity-Modulated Radiation Therapy (IMRT) + Bevacizumab (BV) [NSC 708865; IND 7921] for Locally or Regionally Advanced Nasopharyngeal Cancer
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| Eligibility: |
Biopsy proven (from primary lesion and/or lymph nodes) diagnosis of Stage IIB-IVB (AJCC, 6th ed.) non-metastatic cancer of the nasopharynx; Patients who present with T1-2N1 disease in which node positivity is based on the presence of retropharyngeal lymph nodes are not eligible.) Histologic types WHO I-IIb/III; Zubrod Performance Status 0-1; Age > 18; Adequate bone marrow function, renal function, and hepatic function as defined in the protocol; Urine protein: creatinine ratio (UPC ratio) of < 1.0 within 8 weeks prior to registration; International normalized ratio (INR) < 1.5 and activated partial thromboplastin time (aPTT) < 1.5 X UNL within 2 weeks prior to registration; The patient must have the nutritional and physical condition considered to be compatible with the proposed treatment regimen; Negative serum pregnancy test 2 weeks prior to registration; Patients must sign study specific informed consent prior to registration.
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| Treatment | Concurrent phase: 3D-CRT or IMRT, Cisplatin, and Bevacizumab
Adjuvant phase: 5-Fluorouracil, Cisplatin, and Bevacizumab
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| Study size: | 46 |
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