Table 1. Radiation Therapy Compliance.
| Disease Site | RTOG Trial(reference #) | Study Design | Pt. # | Cases Reviewed # | Per-Protocol (%) | Variation Acceptable (%) | Deviation Unacceptable (%) | Other† (%) |
|---|---|---|---|---|---|---|---|---|
| Esophageal Trials | 9405 (15) | Phase III Trial of Combined Modality Therapy for Esophageal Cancer: High-Dose (A) vs. Standard-Dose RT (B) | 218 | A: 109 B: 108 |
A: 61 B: 79 |
A: 11 B: 8 |
A: 4 B: 5 |
A: 24 B: 8 |
| 0113 (16) | Phase II Randomized Trial of Two Nonoperative Regimens (A, B) of Induction Chemo Followed by ChemoRT with Localized Carcinoma of the Esophagus | 76 | A: 39 B: 37 |
A:46 B: 70 |
A:35 B: 11 |
A: 3 B: 0 |
A: 15 B: 19 |
|
| 0246 (17) | Phase II Study of a Paclitaxel-Based ChemoRT Regimen With Selective Surgical Salvage for Resectable Locoregionally Advanced Esophageal Cancer | 41 | 39 | 87 | 0 | 0 | 13 | |
| Gastric Trials | 9904 (18) | Phase II Trial of Preoperative ChemoRT in Patients with Localized Gastric Adenocarcinoma | 43 | 43 | 37 | 7 | 42 | 14 |
| 0114# (19) | Randomized Phase II Trial Evaluating Two Paclitaxel and Cisplatin-Containing ChemoRT Regimens (A, B) as Adjuvant Therapy in Resected Gastric Cancer | 73 | A: 28 B: 45 |
A: 64 B: 53 |
A: 11 B: 11 |
A: 4 B: 2 |
A: 21 B: 33 |
|
| Liver Trial | 0438# (20) | Phase I Study of Tightly Conformal RTfor Liver Metastases | 23 | 23 | 87‡ | 13 | 0 | 0 |
| Pancreas Trials | 9704 (21) | Phase III Study of Pre and Post ChemoRT 5-FU (A) vs. Pre and Post ChemoRT Gemcitabine (B) for Postoperative Adjuvant Treatment of Resected Pancreatic Adenocarcinoma | 451 | A: 230 B: 221 |
A: 51 B: 45 |
A: 36 B: 43 |
A: 5 B: 5 |
A: 8 B: 7 |
| 9812 (22) | Phase II Trial of External RT (50.4 Gy) and Weekly Paclitaxel (Taxol) for Non-Metastatic, Unresectable Pancreatic Cancer | 109 | 109 | 88 | 5 | 2 | 6 | |
| 0020 (23) | Randomized Phase II Trial of Weekly Gemcitabine, Paclitaxel and External RT (50.4 Gy) Followed by the Farnesyl Transferase Inhibitor R115777(A, B) (NSC #702818) for Locally Advanced Pancreatic Cancer | 185 | A: 91 B: 94 |
A: 60 B: 57 |
A: 33 B: 30 |
A: 0 B: 3 |
A: 7 B: 10 |
|
| 0411 (24) | Phase II Study of Bevacizumab with Concurrent Capecitabine and RT Followed by Maintenance Gemcitabine and Bevacizumab for Locally Advanced Pancreatic Cancer | 82 | 82 | 73 | 7 | 13 | 6 | |
| Rectal Cancer Trials | 0012 (25) | Randomized Phase II Trial of Preoperative Combined Modality ChemoRT (A, B) for Distal Rectal Cancer | 103 | A:50 B:53 |
A: 72 B: 77 |
A:16 B: 21 |
A: 4 B: 2 |
A: 8 B: 0 |
| 0247 (26) | Randomized Phase II Trial of Neoadjuvant Combined Modality Therapy (A, B) for Locally Advanced Rectal Cancer | 139 | A: 70 B: 69 |
A: 70 B: 67 |
A: 17 B: 26 |
A: 1 B: 1 |
A: 11 B: 6 |
|
| 0822# (27) | Phase II Evaluation of Preoperative ChemoRT utilizing IMRT in Combination with Capecitabine and Oxaliplatin for Patients with Locally Advanced Rectal Cancer | 68 | 68 | 85 | 7 | 7 | 0 | |
| Anal Cancer Trials | 9811 (28) | Phase III Trial of Fluororouracil, Mitomycin and RT (A) vs. Fluorouracil, Cisplatin and RT(B) for Carcinoma of the Anal Canal | 649 | A: 325 B: 324 |
A: 68 B: 69 |
A: 22 B: 18 |
A: 6 B: 8 |
A: 3 B: 6 |
| 0529# (29) | Phase II Evaluation of Dose-Painted IMRT in Combination with 5-Fluorouracil and Mitomycin-C for Reduction of Acute Morbidity in Carcinoma of the Anal Canal | 52 | 52 | 85* | 13 | 0 | 2 | |
| TOTAL | 2312 | 2309 | 65 | 21 | 5 | 8 |
Abbreviations: RT, radiation therapy; chemo, chemotherapy; chemoRT, chemoradiation; IMRT, Intensity Modulated Radiation Therapy.
†
Other - no RT given or incomplete RT: death, progression or refusal
‡
Tumor volume contouring score
*
Planning Target Volume (PTV) anal score
#
: Trials undergoing pre-treatment review