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Site:
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Gastroesophageal
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ID:
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CALGB 80101 Phase III
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Name:
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Adjuvant. Chemo-rad ( 5FU/LV) versus (Epirubicin/Cisplatin/5-FU) after resection of gastric or gastroesophageal adenoca
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Stage:
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IB
II
IIIA of B
IV MO
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Eligibility:
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En bloc resection of all known tumor. Must extend beyond muscularis propria or nodal involvement. MI disease excluded. No prior chemo or rads. PS 0-2. Stable weight.
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Site:
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Esopheageal/GE Juncton Opened 10/17/07
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ID:
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CALGB 80403/ E1206 Phase II
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Name:
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Study of ECF-C, IC-C, or FOLFOX-C in Metastatic Esopheageal and GE Junction CA
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Stage:
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-
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Eligibility:
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Histo, cytologic or radiologic documentation of metastatic squamous cell carcinoma or adeno of the esophagus or GE junction.Radiologic, endoscopic, histologic or cytologic evidence of locally recurrent or locally residual (post-resection) disease is also permitted. Pts must have measurable disease, no prior chemo or RT, must have completed any major surgery > 4 wks or any minor surgery > 2 wks before registration. PS 0-2, no MI < 6 months prior to registration or NY Heart Associationj classification III or IV, No > 2 diarrhea within 7 days prior to registration. See Protocol for further eligibility/ineligibility criteria
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Site:
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Colon
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ID:
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ECOG 5202 Phase III
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Name:
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Comparing 5-Fu, Leucovorin + Oxaliplatin vrs. 5-FU, Leucovorin, Oxaliplatin + Bevacizumab in pts. with stage II colon ca at high risk for recurrence to determine prospectively the prognostic value of molecular markers
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Stage:
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Stage II
(T3,4 N0, M0)
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Eligibility:
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Distal extent of tumor >12 cm from anal verge on endoscopy. Histologically confirmed adeno of colon
Must have > 8 L.N. evaluated and reported. P.S. 0-2. Pts must not have presented with obstruction or perforation of bowel. No systemic or RT initiated for this malignancy. Prior malignancies, including colorectal cancers are eligible if disease-free >5yrs.and low risk for recurrence. See protocol for further criteria
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Site:
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Colon
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ID:
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NCCTG N0147 Phase III
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Name:
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Oxaliplatin Plus 5 FU /Leucovorin with or without Cetuximab after Curative Resection for Patients with Stage III Colon CA
**Study temporarily suspended but will reopen to enrollment with the activation of amendment #9** (Refer to last page for explanation)
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Stage:
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Stage III
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Eligibility:
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Histologically documented adeno ca. Gross inferior (caudal) margin of primary tumor must be > 12 cm from anal verge by rigid proctoscopy (pts. with rectal ca are not eligible. Tumor must have been completely resected. In pts with tumor adherence to adjacent structures en bloc resection must be documented in the operative report. Pts with tumor-related obstruction or colonic perforation are eligible for enrollment. Must have at least one pathologically confirmed positive LN identified. No evidence of residual involved LN PS 0-1 or 2. Age > 18 years. No distant mets at time of randomization. No prior chemo or RT
See protocol for further eligibility/ ineligibility criteria
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Site:
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Colorectal
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ID:
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CALGB 80405 Phase III
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Name:
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Irionotecan/5-FU/Leucovorin or Oxaliplatin/5-FU/Leucovorin with Bevacizumab, or Cetuximab (C225), or with the Combination of Bevacizumab and Cetuximab for Patients with Untreated Metastatic Adenocarcinaom of the Colon or Rectum
** Study temporarily suspended but will reopen when a revised protocol is issued** (Refer to last page for explanation)
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Stage:
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-
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Eligibility:
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Eligible pts. must have histologically or cytologically documented adenocarcinoma of the colon or rectum. Pts. must have either locally advanced (unresectable) or metastatic disease. Pts with resected primary tumors who have documented metastases are eligible. No prior treatment for advanced or metastatic colorectal ca. No prior RT to > 25% of bone marrow. >4 weeks since major surgery. No previous or concurrent malignancy. Paraffin block or slides must be available. PS 0-1 See protocol for further eligibility criteria.
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