Neoplasms

All Conditions

Digestive System Diseases

Gland and Hormone Related Diseases

Rare Diseases

Cholangiocarcinoma

Pancreatic Neoplasms

Gallbladder Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Adenocarcinoma

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Biliary Tract Neoplasms

Biliary Tract Diseases

Gallbladder Diseases

Pancreatic Cancer

Bile Duct Cancer

Gallbladder Cancer

Antineoplastic Agents

All Drugs and Chemicals

Gemcitabine

Docetaxel

Fluorouracil

Antimetabolites

Tubulin Modulators

Antimitotic Agents

Gemcitabine 1000 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles

Docetaxel 35 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles

5FU CIVI 225 mg/m2 per day throughout radiation (starts 3 weeks after start of cycle 2)

Radiation 5040 cGy or 5400 cGy for positive margins (starts 3 weeks after start of cycle 2). Daily dose of 1.8 Gy five days per week.

Gemcitabine 1000 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)

Docetaxel 35 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)

Radiation

Benjamin Tan, M.D.

To assess the feasibility of administering induction chemotherapy with gemcitabine and docetaxel followed by concurrent radiation and continuous infusion 5FU and consolidation gemcitabine/docetaxel chemotherapy.

A Feasibility Phase II Study in the Treatment of Resected Cholangiocarcinoma, Gallbladder, Pancreatic and Ampullary Cancers

A Feasibility Phase II Study of Gemcitabine With Docetaxel With Concurrent 3-D Conformal Radiation Plus Continuous Infusion 5-Fluorouracil in the Treatment of Resected Cholangiocarcinoma, Gallbladder, Pancreatic and Ampullary Cancers

Toxicity was graded according to National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 2.0

Toxicity was graded according to National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 2.0. The most common grade 1-2 non-hematologic and hematologic toxicities were collected for this outcome.

Toxicity was graded according to National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 2.0. The most common grade 3-4 non-hematologic and hematologic toxicities were collected for this outcome.

DFS was defined as the time from the initiation of treatment to relapse or death, whichever occurred first.

OS was defined as the time from the initiation of treatment to death from any cause or last follow-up.

OS was defined as the time from the initiation of treatment to death from any cause or last follow-up

Washington University School of Medicine

Arm 1

Arm 1 (Gemcitabine, Docetaxel, 5FU, Radiation)

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

-There are some staging differences between biliary tract cancer, pancreatic cancer, and ampullary cancer but general staging information is listed below:

* Stage I (best outcome) and Stage II means that there is only cancer in the primary site with no spread to local lymph nodes or spread to other sites of the body.
* Stage III means that the cancer is in the primary site, possibly in nerves and blood vessels around the primary site, and may be in nearby lymph nodes.
* Stage IV means that the cancer has spread to distant parts of the body (worst outcome)

Overall stage

Pancreatic cancer

Biliary tract cancer

Ampullary cancer

Disease type

* T describes the size of the main (primary) tumor and whether it has grown outside the primary site and into nearby organs.
* T1 is generally associated with a better outcome and the outcome generally worsens as you increase the T number

T-stage

N describes the spread to nearby (regional) lymph nodes.

X: Nearby (regional) lymph nodes cannot be assessed.

N0: The cancer has not spread to nearby lymph nodes.

N1: The cancer has spread to nearby lymph nodes.

N-stage

Well

Moderate

Poor

Not reported

Well-differentiated cancer cells look more like normal cells and tend to grow and spread more slowly than poorly differentiated or undifferentiated cancer cells.

Differentiation

Not Reported

Lymphovascular involvement

40-100

>100

* Generally the higher the CA19-9 level the more the cancer is growing
* High CA 19-9 levels can also be caused by non-cancerous conditions such as gallstones, a blockage of the bile duct (jaundice), pancreatitis, cystic fibrosis, and liver disease.

Spots Global Cancer Trial Database for A Feasibility Phase II Study in the Treatment of Resected Cholangiocarcinoma, Gallbladder, Pancreatic and Ampullary Cancers

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial