Table 1. Study Descriptions .
| Type of Cancer | Trials by Study No. | Enrollment Date Range | Major Eligibility Criteria | Clinical Prognostic Factorsa | Rural/Total Sample, No. (%) |
|---|---|---|---|---|---|
| Brain | S8737, S0001 | 1988-2005 | No prior chemotherapy; performance status ≤2 | Prior surgery: biopsy only vs resection; performance status: 0-1 vs >1 | 74/323 (22.9) |
| Breast, adjuvant ER-negative and PR-negative | S8897, S9313, S9623, S0012, S0221, S0307 | 1989-2012 | Early stage (I-III); no prior chemotherapy for this breast cancer (for S0307, chemotherapy allowed concurrent with registration) | No. of positive lymph nodes: ≥4 vs <4; tumor size: ≤5 cm vs >5 cm; premenopausal vs postmenopausal | 875/5026 (17.4) |
| Breast, adjuvant ER-positive and/or PR-positive | S8814, S8897, S9313, S9623, S0012, S0221, S0307 | 1989-2012 | Early stage (I-III); no prior chemotherapy for this breast cancer (for S0307, chemotherapy allowed concurrent with registration) | No. of positive lymph nodes: ≥4 vs <4; tumor size: ≤5 cm vs >5 cm; premenopausal vs postmenopausal | 1977/11 413 (17.3) |
| Breast, advanced | S0226, S0500 | 2004-2012 | Stage IV; no prior chemotherapy for metastatic disease | ERBB2 (formerly HER2)–negative vs ERBB2-positive; premenopausal vs postmenopausal; ER-positive and/or PR-positive vs ER-negative and PR-negative | 244/1247 (19.6) |
| Colorectal, advanced | S8611, S8905, S9420 | 1987-1999 | Metastatic (disseminated); maximum 1 prior adjuvant chemotherapy or immunotherapy | Performance status: 0-1 vs 2 | 286/1431 (20.0) |
| Gastric, adjuvant | S9008 | 1991-1998 | Stages IB-IV (M0) | No. of involved lymph nodes: 0 vs 1-3 vs ≥4; T stage: T1-T2 vs T3-T4 | 83/488 (17.0) |
| Colorectal, adjuvant | S9304, S9415 | 1994-2000 | Stage M0; no prior systemic or radiation therapy | No. of nodes involved: N0 vs N1 vs N2-N3; performance status: 0-1 vs 2; invasion of perirectal fat or adjacent organs: T1-T2 vs T3-T4 | 605/2593 (23.3) |
| Prostate 1, advanced | S8894 | 1989-1994 | D2 disease | Performance status: <2 vs ≥2; severity of disease: minimal vs extensive | 304/1333 (22.8) |
| Prostate 2, advanced | S9346 | 1995-2008 | D2 disease | Performance status: <2 vs ≥2; severity of disease: minimal vs extensive | 320/2055 (15.6) |
| Prostate, advanced hormone refractory | S9916, S0421 | 1999-2010 | Metastatic prostate cancer that is unresponsive or refractory to hormone therapy; maximum 1 prior systemic therapy | Extraskeletal metastatic disease: yes vs no; PSA progression only: yes vs no; performance status: <2 vs ≥2 | 325/1658 (19.6) |
| Ovarian, advanced | S8501, S8790, S9701 | 1986-2001 | Stage III or IV | Disease: optimal stage III vs suboptimal stage III or stage IVb | 170/903 (18.8) |
| Acute myeloid leukemia | S8600, S8706, S9031, S9333, S0106 | 1986-2009 | No previous systemic chemotherapy for acute leukemia | SWOG performance status: <2 vs ≥2 | 455/1748 (26.0) |
| NSCLC, advanced | S8738, S9308, S9509, S0003 | 1988-2002 | No previous systemic chemotherapy or biologic therapy for NSCLC | Weight loss: <5% vs ≥5%; LDH: normal (≤ULN) vs abnormal (>ULN); stage of disease: IIIB vs IV | 304/1461 (20.8) |
| Non-Hodgkin lymphoma, advanced aggressive | S8516, S9704 | 1986-2007 | Intermediate or high-grade histology; no prior chemotherapy or radiation therapy for lymphomac | IPI risk: low vs low-intermediate vs high-intermediate vs high | 278/1155 (24.1) |
| Non-Hodgkin lymphoma, advanced indolent | S0016, S8809 | 1988-2008 | Stages IIB-IV; no prior chemotherapy or radiation therapy for lymphoma | IPI risk: low vs low-intermediate vs high-intermediate vs high | 209/1035 (20.2) |
| Myeloma, multiple | S8624, S9028, S9210, S9321, S0232, S0777 | 1987-2012 | No prior chemotherapy for this disease | Stage: I-II vs III | 568/2493 (22.8) |
| Gastrointestinal stromal tumor, advanced | S0033 | 2000-2001 | Metastatic or unresectable | Performance status: 0-2 vs 3; measurable vs nonmeasurable disease | 107/633 (16.9) |
| Total | 44 unique trials | 1986-2012 | 7184/36 995 (19.4) |
Abbreviations: ER, estrogen receptor; IPI, International Prognostic Index; LDH, lactate dehydrogenase; NSCLC, non–small cell lung cancer; PR, progesterone receptor; PSA, prostate-specific antigen; ULN, upper limit of normal.
a
Including age (<65 vs ≥65 years), race (black vs other), and sex (where appropriate).
b
Definitions for suboptimal vs optimal stage III differed by study.
c
Study S9704 allows a single course of chemotherapy consisting of cyclophosphamide, doxorubicin, vincristine, and prednisone with or without rituximab.