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ProtocolTrial Name and Objective
071301

Comparative Analysis of Duodenal reconstruction with Roux-en-Y versus Primary Closure post Partial Duodenectomy - A Retrospective Chart Review

The optimal method of duodenal reconstruction following resection for oncologic surgery is not clear. We aim to clarify this through an analysis of outcomes following our experience with surgical reconstruction of the duodenum
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131307

Couple-Focused Intervention for Colorectal Cancer Screening

Specific Aim 1:To compare the efficacy of three interventions: Enhanced Couple-Tailored Intervention (E-CTI), an Enhanced Couples' Generic Intervention (E-GCI), and a Generic Print Intervention (GP) on couples' CRCS.
Hypothesis:CRCS rates at follow-up will be 22-30% in E-CTI, 12-15% in E-GCI, and 8% in GP.

Specific Aim 2:To evaluate the individual (perceived risk, decisional balance, planning, intentions) and relationship-level (relationship perspective, support for spouse screening, couples'discussions) factors which mediate E-CTI effects on couples' CRCS when compared with E-GCI and GP.
Hypothesis: E-CTI will result in significantly higher risk, more positive decisional balance, greater planning, higher CRCS intentions, adoption of greater relationship perspective on CRCS, more support for the partner's CRCS, and more frequent CRCS discussions when compared with E-GCI and GP, and that the meditational effect will be stronger in E-CTI.

Exploratory Aim: To evaluate the individual (gender, baseline intentions, support for spouse's screening, insurance status) and relationship-level (marital quality) factors which moderate E-CTI effects on couples' CRCS practices when compared with E-GCI and GP.
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001307

Molecular Analysis of Rare Tumors Subclasses

The overall aim is to determine what set of genomic alterations are present in ampullary cancers. If we find that, similar to our index case, activating mutations in tyrosine kinases are present in a significant subset of these cancers, this finding may lead to novel therapeutic strategies for these cancers.
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071008

CALGB C80702: A Phase III Trial of 6 versus 12 Treatments of Adjuvant FOLFOX plus Celecoxib or Placebo for Patients with Resected Stage III Colon Cancer

To compare disease-free survival of patients with stage III colon cancer randomized to standard chemotherapy (FOLFOX) or standard chemotherapy with 3 years of celecoxib 400 mg daily.
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071203

CALGB 80803: Randomized Phase II Trial of PET Scan-Directed Combined Modality Therapy in Esophageal Cancer

Primary: 1) To induce a pCR rate of 20% in PET scan responders treated with either induction FOLFOX or carboplatin/paclitaxel, who then cross over to the other regimen during radiotherapy
Secondary: 1) To compare pCR between induction treatment arms among PET/CT responders
2) To compare pCR between induction treatment arms among PET/CT responders
3)If both treatment regimens are found to be efficacious, to directly compare pCR between induction treatment arms among non-responders
4) To determine 8-month PFS in PET/CT scan responders, and in non-responders treated with alternative crossover chemoradiotherapy
5) Estimate the PFS and overall survival, overall and among PET responders and PET/CT non-responders by induction treatment
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071304

BAY 73-4506/15983: A Randomized, Double-blind, Placebo-controlled Phase-III Study of Adjuvant Regorafenib Versus Placebo for Patients with Stage IV Colorectal Cancer After Curative Treatment of Liver Metastases

To evaluate and compare the efficacy and safety of regorafenib versus placebo in subjects with colorectal cancer (CRC) after curative resection of liver metastasis and completion of all planned chemotherapy
In this study, the primary efficacy endpoint is disease-free survival (DFS) as assessed by the investigator; the secondary efficacy endpoint is overall survival. The exploratory efficacy endpoints are:
 Health-Related Quality of Life as assessed by the European Quality of Life Group five dimension 3-level and European Organization for Research and Treatment of Cancer Quality of Life-C30 questionnaires
 Biomarker evaluations
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051304

Phase IB Study of MK-3475 in Subjects with Select Advanced Solid Tumors

To evaluate preliminary signals of potential anti-tumor activity of MK-3475
in subjects with a given a histopathologic type of PD-L1 positive advanced solid tumor based on RECIST 1.1 as determined by the investigator in specific tumor indications
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071306

DEK-DKK1-P102: A Two Part, Phase 1, Multi-center, Open-label Study of DKN-01 in Combination with Weekly Paclitaxel; Arm A: A Dose-Escalation Study in Patients with Relapsed or Refractory Esophageal Cancer or Gastro-esophageal Junction Tumors; Arm B: An Expansion Cohort in Patients with Relapsed or Refractory Esophageal Cancer or Gastro-esophageal Junction Tumors

Primary Objective
The primary objective of this study is to characterize the safety and tolerability of DKN-01 in combination with weekly paclitaxel in patients with refractory/recurrent esophageal or gastro-esophageal junction cancer.

Secondary Objectives
The secondary objectives of this study are:
h To estimate the overall response rate (ORR) of patients with refractory/recurrent esophageal or gastro-esophageal junction cancer treated with DKN-01 in combination with paclitaxel.
h To estimate progression free survival (PFS), duration of response (DoR), and overall survival (OS) of patients with refractory/recurrent esophageal or gastro-esophageal junction cancer treated with DKN-01 in combination with paclitaxel.
h To characterize the pharmacokinetics of DKN-01 in combination with paclitaxel in patients with refractory/recurrent esophageal or gastro-esophageal junction cancer
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071401

CALGB A021202: Prospective Randomized Phase II Trial of Pazopanib (NSC # 737754, IND 75648) Versus Placebo in Patients with Progressive Carcinoid Tumors

Primary Objective
For patients with progressive carcinoid tumors, progression-free survival (PFS defined by central review according to RECIST 1.1) will be compared between patients randomized to treatment with pazopanib versus placebo.

Secondary Objectives
Overall Survival will be compared between treatment arms.
Objective Response Rate duration of response, and time to treatment failure will be compared between treatment arms.
Progression Free Survival as assessed by central radiology review and local radiology review will be compared overall and within treatment arms.
PFS at 6 months and 12 months will be estimated within each treatment arm.
Safety and Tolerability of treatment with pazopanib/placebo will be evaluated within each treatment arm.
Biochemical response (for chromogranin A, defined as a decrease of 50% or more in plasma chromogranin A levels from baseline and for 5-HIAA, defined as a decrease of 50% or more in urinary 5-HIAA levels from baseline) will be compared between treatment arms among patients with elevated baseline levels of CGA and 5-HIAA.
PFS and other indicators of efficacy will be estimated in patients who crossover to pazopanib from placebo.
Imaging objectives
Average time to submission of scans to the ICL and average ICL 'turn-around' time will be estimated.
Discordance between the local and central radiology review in assessment of progression will be estimated.
The rates and quality of radiographic progression (pre-study, on-study, and post-progression) will be characterized.
Quality of life objectives
To assess for differences in QOL-related domains between the two treatment groups (pazopanib versus placebo)
To determine if the more brief measures of QOL-related domains provide comparable information to that which is provided by the longer assessments (EORTC, NET21)
To provide validation data for the EORTC NET21 module in terms of responsiveness over time and differences across arms
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071403

Neogenix0901: A Phase 1/2 Therapeutic, Open Label, Multi-Center Clinical Trial of NPC-1C, a Chimeric Monoclonal Antibody in Adults with Recurrent, Locally Advanced Unresectable or Metastatic Pancreatic and Colorectal Cancer after Standard Therapy

Determine the safety and tolerability of escalating doses of NPC-1C (NEO-102) monoclonal antibody therapy in subjects with metastatic, locally advanced unresectable or recurrent pancreatic cancer or metastatic colorectal cancer that express NPC-1C target on tumor;
h Using the recommended phase 2 dose (RP2D) evaluate the overall survival (OS) associated with administration of NPC-1C(NEO-102) in subjects with metastatic, locally advanced unresectable or recurrent pancreatic cancer or metastatic colorectal cancer, that express NPC-1C target on tumor
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051406

NCI/CTEP #9571: A Phase IB Study of the Combination of AZD6244 Hydrogen Sulfate (Selumetinic) and Cyclosporin A (CsA) in Patients with Advanced Solid Tumors with an Expansion Cohort in Metastatic Colorectal Cancer

Primary Objective: To determine the maximum tolerated dose (MTD)and dose-limiting toxicities (DLT) of the combination of AZD6244 and cyclosporin A in adult patients with advanced solid tumors.
Seconday Objectives: (1) To determine the safety profile and tolerability of thsi regimen in this patient population. (2) To determine the pharmacokinetics of the combination. (3) To evaluate the selected biomarkers of drug effect in patients with advanced solid tumors or metastatic CRC. (4) Evaluate the activity of the combination in terms of objective response rate (per RECIST 1.1), overall survival, and progression-free survival.
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071410

TO-TAS-102-401: AN OPEN-LABEL EXPANDED ACCESS STUDY OF TAS-102 IN PATIENTS WITH METASTATIC COLORECTAL CANCER REFRACTORY TO OR FAILING STANDARD CHEMOTHERAPY

TO provide access to TAS-102 to patients with metastatic colorectal cancer who are refractory to or failing standard chemotherapy, are new to therapy with TAS-102 and in whom therapy with TAS-102 is clinically indicated, in the time period between completion of the Phase 3 clinical trial protocol TPU-TAS-102-301 and prior to TAS-102 being commercially available. This is an unmet clinical need
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