PURPOSE: Patients with clinically negative nodes constitute over 85% of new melanoma cases. There is no adjuvant therapy for intermediate-thickness, node-negative patients. PATIENTS AND METHODS: The Southwest Oncology Group conducted a randomized phase III trial an allogeneic vaccine 2 years versus observation in patients intermediate-thickness (1.5 to 4.0 mm or Clark’s level IV if thickness unknown), pathologically (T3N0M0). RESULTS: Six hundred eighty-nine were accrued 4.5 years; 89 (13%)...

Abstract BACKGROUND: On the basis of retrospective experience at individual centers, it appears that patients with stage IV melanoma who undergo complete resection have a favorable outcome compared disseminated disease. The Southwest Oncology Group (SWOG) performed prospective trial in metastatic were enrolled before their disease and provided outcomes cooperative group setting. METHODS: Based on physical examination radiologic imaging studies, judged amenable to underwent surgery within 28...

Antibody directed against a cultured melanoma cell line known to express an oncofetal antigen was measured in sera obtained from patients with stage II melanomas. This study undertaken determine if inhibiting or enhancing effect on tumor growth would be suggested by positive negative correlation of antibody levels recurrence patient survival. A disease-free interval and survival detected among who had high the IgM class before shortly after surgery for state disease. The IgG over period did...

The potential involvement of cytokines in acute graft-versus-host disease led us to analyze interleukin-6 serial serum sets from 22 allogeneic marrow recipients who developed either grade 3 or 4 GVHD (n = 10), 2 6), 1 no diagnosed 6). A total 279 samples taken three times weekly before day 35 were analyzed. Maximum IL-6 levels >40 U/ml (range, 40–1536 U/ml), 11–40 U/ml, and ≤10 for six, eleven, five patients, respectively. Serum peaks temporally related onset GVHD, a syndrome hepatorenal...

In cancer clinical trials new regimens are typically tested for antitumor activities in patients with advanced disease. The promising ones then compared to the standard treatment a randomized study, sometimes performed on earlier-stage When there multiple regimens, it may not be possible compare all of them control group because prohibitive sample size and study length requirements. We propose design that uses Cox regression model select best based survival before comparison. Sample sizes an...

Abstract In animal carcinogenesis experiments or comparative clinical trials where the r groups correspond to increasing dosages of an agent number additional modalities and primary outcome is time a certain event (e.g., tumor occurrence, death) T, ordered alternatives form H1 : S1 ≤ S2 · Sr , Si(t) = Pr (Ti > t) survival function for group are special interest. Using counting process formulation problem generalizing earlier results, we show that class all two-sample weighted logrank...

This report provides follow-up progression-free survival (PFS) and median data for women who achieved clinical complete remission (cCR) from stage III ovarian cancer after first-line therapy were treated with altretamine consolidation therapy.Patients enrolled in the SWOG 9326 study September 1993 to July 1997 required have documented cCR following front-line platinum-based therapy. Treatment consisted of 6 months oral at 260 mg/m(2)/day 14 consecutive days a 28-day cycle.Ninety-seven 112...

The objective of this study was to determine response and overall survival (OS) progression-free (PFS) following cisplatin plus tirapazamine treatment in eligible consenting patients with metastatic or recurrent squamous adenosquamous carcinoma the cervix. Treatment consisted intravenous tirapazamine, 260 mg/m(2), followed by cisplatin, 75 every 21 days for six cycles. Of 56 registered cases, 52 were evaluable toxicity. There grade 4 toxicities (anemia [three], dyspnea [one],...

2004 Background: Ixabepilone (Ix) is a semisynthetic Epothilone B derivative with antitumor activity in breast cancer pts previously treated taxanes and chemotherapy naïve prostate pts. Because Ix hepatically metabolized, the following study was performed to define dosing recommendations for varying degrees of hepatic impairment. Methods: Pts were classified into dysfunction cohorts defined by modified NCI Organ Dysfunction Working Group (NCI) schema. Starting doses escalated new...

8019 Background: Surgery is the treatment of choice for isolated distant metastases melanoma. Based on a number retrospective reports, patients (pts) who have undergone complete resection metastatic disease can an excellent survival. Methods: In SWOG, we prospectively evaluated surgical stage IV Pts enrolled prior to surgery; following was at discretion treating physician. Resected specimens were collected, whenever possible, future molecular analyses. Results: Over 9 year period from 1996...

As one of the most commonly used data types, methods in testing or designing a trial for binary endpoints from two independent populations are still being developed until recently. However, power and minimum required sample size comparisons between different tests may not be valid if their type I errors controlled at same level. In this article, we unify all related procedures into decision framework, including both frequentist Bayesian methods. Sufficient conditions error attained boundary...

Data Monitoring Committees in the Southwest Oncology Group comprise study leadership and of Group, augmented by some outside representation. The early stopping guidelines used these committees are explicit each protocol, can be characterized as specifying a few interim analyses at conservative statistical levels. We describe our ten years experience with this system, give examples different trials which have stopped either for positive or negative results.

5551 Background: There is a continuing debate over the role of combination, platinum-based chemotherapy for PS, recurrent ovarian cancer (OC). Although this phase 3 trial was closed prematurely by SWOG Data Safety and Monitoring Committee (DSMC) due to slow patient accrual, it provided provocative results nonetheless. Methods: Patients with stage III or IV OC, progression-free platinum-free interval 6- 24 months after completion first-line chemotherapy, up 12 courses non-platinum containing...

Objective This report provides follow-up progression-free survival (PFS) and median data for women who achieved clinical complete remission (cCR) from stage III ovarian cancer after first-line therapy were treated with altretamine consolidation therapy. Methods Patients enrolled in the SWOG 9326 study September 1993 to July 1997 required have documented cCR following front-line platinum-based Treatment consisted of 6 months oral at 260 mg/m 2 /day 14 consecutive days a 28-day cycle. Results...

Objective: To investigate the accuracy of full arch scans taken using iTero Element 2 ® under clinical settings. Design: Prospective study. Methods: A customised upper removable appliance (URA) with four spheres (A–D) was fabricated from a maxillary scan for 24-year-old patient. Six linear values were measured on URA high-accuracy coordinate measuring machine. total 60 intra-oral by two operators (HA and AS) test inserted to participant’s dentition at T1 T2. Geomagic Control X software used...

The objective of this study was to determine response and overall survival (OS) progression-free (PFS) following cisplatin plus tirapazamine treatment in eligible consenting patients with metastatic or recurrent squamous adenosquamous carcinoma the cervix. Treatment consisted intravenous tirapazamine, 260 mg/m 2 , followed by cisplatin, 75 every 21 days for six cycles. Of 56 registered cases, 52 were evaluable toxicity. There grade 4 toxicities (anemia [three], dyspnea [one],...

Journal Article Nonparametric sequential tests against ordered alternatives in multiple-armed clinical trials Get access D. Y. LIN, LIN 1Department of Biostatistics, SC-32, University WashingtonSeattle, Washington 98195, U.S.A. Search for other works by this author on: Oxford Academic Google Scholar P. LIU 2Fred Hutchinson Cancer Research Center1124 Columbia Street, Seattle, 98104, Biometrika, Volume 79, Issue 2, June 1992, Pages 420–425, https://doi.org/10.1093/biomet/79.2.420 Published: 01 1992