Photodynamic Therapy (PDT) Trial for Palliation of Cholangiocarcinoma

NCT00907413 | Terminated Phase 3 DMC

• 1 other identifier: 13898
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This research study is a phase III double arm, multicenter, randomized controlled clinical trial comparing endoscopic retrograde cholangiopancreatography (ERCP) and stenting plus photodynamic therapy (PDT) versus ERCP with stenting alone in adult patients with unresectable cholangiocarcinoma. The study objectives are to investigate the efficacy of photodynamic therapy (PDT) in increasing the survival time of patients with unresectable cholangiocarcinoma and to assess the effect of PDT on both cholestasis and health-related quality of life (HRQoL).

Conditions

Cholangiocarcinoma

Keywords

cancer; bile duct

Outcome Measures

Primary Outcomes (1)

• Survival time in each group will be compared as well as effect of each treatment arm on cholestasis and HRQoL

  2.4 years

Study Arms (2)

ERCP and PDT

EXPERIMENTAL

Endoscopic Retrograde Cholangio Pancreatography (ERCP) and stenting combined with Photodynamic Dynamic Therapy ERCP and PDT

Procedure: ERCP and Photodynamic Therapy; Procedure: ERCP only

ERCP alone

ACTIVE COMPARATOR

Endoscopic Retrograde Cholangio Pancreatography (ERCP) with stenting alone

Procedure: ERCP only

Interventions

ERCP and Photodynamic Therapy PROCEDURE

Photodynamic Therapy is a new therapeutic approach that specifically targets neoplastic cells. This therapy has been used in other tumors as a local treatment and involves the intravenous administration of a photosensitizing agent followed by activation of the agent by illumination with non-thermal light of a specific wavelength, resulting in cell death from direct cytotoxicity and ischemic necrosis. Cytotoxicity is directly proportional to tissue oxygenation.

ERCP and PDT

ERCP only PROCEDURE

Endoscopic retrograde cholangiopancreatography and stenting.

ERCP alone; ERCP and PDT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient is age 18 years or older
• Patient is diagnosed with non-resectable cholangiocarcinoma, as determined by CT within 30 days of enrollment and CT shows Bismuth Tumor Stage as: IIIa, IIIb, IV (Bismuth tumor stage I and II are not eligible to participate)
• Patients must have adequate organ and marrow function as defined below:
• Patient's INR ≤ 2 within 30 days of treatment
• Patient's platelets \> 50,000/cmm within 30 days of treatment
• Patient's Absolute Neutrophil Count (ANC) \> 1,500/cmm within 30 days of treatment
• Patient's creatinine ≤ 3 mg/dL within 30 days of treatment
• Patient has the ability to understand and the willingness to comply with the study procedures and provide written informed consent to participate in the study

You may not qualify if:

• Patient was diagnosed with cholangiocarcinoma more than 3 months ago
• Patient has any metastatic disease
• Patient has acute porphyria
• Subjects exhibiting neurologic or cutaneous symptoms will undergo urinary delta-aminolevulinic acid and porphobilinogen dosage tests to determine severity.
• Patient is pregnant (Women of child bearing age must have a negative pregnancy test prior to registration and must agree to use adequate contraception during study therapy)
• Patient has a concurrent non solid malignancy

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Sites (1)

University of Virginia

Charlotteville, Virginia, 22908, United States

Location

Related Publications (1)

• Cerecedo-Rodriguez J, Phillips M, Figueroa-Barojas P, Kumer SC, Gaidhane M, Schmitt T, Kahaleh M. Self expandable metal stents for anastomotic stricture following liver transplant. Dig Dis Sci. 2013 Sep;58(9):2661-6. doi: 10.1007/s10620-013-2703-0. Epub 2013 May 24.

  PMID: 23703448 DERIVED

MeSH Terms

Conditions

Cholangiocarcinoma; Neoplasms

Interventions

Cholangiopancreatography, Endoscopic Retrograde; Photochemotherapy

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Cholangiography; Radiography, Abdominal; Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Digestive System; Endoscopy, Digestive System; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Combined Modality Therapy; Therapeutics; Drug Therapy; Phototherapy

Study Officials

• Michel Kahaleh, MD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Endoscopy

Study Record Dates

• First Submitted: May 21, 2009
• First Posted: May 22, 2009
• Study Start: May 1, 2010
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: June 3, 2015

Record last verified: 2015-06

Locations

US (1)