Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:55 PM
Ignite Modification Date:
2025-12-24 @ 5:55 PM
NCT ID:
NCT00060268
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed esophageal cancer
* Stages T1-T3, any N, any M
* Tumor partially or completely obstructing the esophagus
* Primary or recurrent tumor meeting 1 of the following criteria for treatment:
* Patient is too debilitated for or refused conventional therapy
* Recurred after or failed to respond to chemotherapy, radiotherapy, or surgery
* Deemed most appropriately treated by photodynamic therapy (PDT) in the opinion of the physician
* Persistent symptomatic disease required in patients who received prior radiotherapy, chemotherapy, or PDT with photofrin or HPPH
* Prior PDT with HPPH allowed only if tumor is evident outside of the original treatment site
* No tracheal or bronchial involvement by bronchoscopy
* No T4 lesions involving the aorta, lung, or pericardium by CT scan, MRI, or endoscopic ultrasonography
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* Not specified
Life expectancy
* Not specified
Hematopoietic
* WBC at least 2,000/mm\^3
* Platelet count at least 50,000/mm\^3
Hepatic
* Bilirubin no greater than 3.0 mg/dL
* Alkaline phosphatase no greater than 3 times upper limit of normal (ULN)
* SGOT no greater than 3 times ULN
* PT no greater than 1.5 times ULN
Renal
* Creatinine no greater than 3.0 mg/dL
Other
* Not pregnant
* Negative pregnancy test
* Fertile patients must use effective contraception
* No contraindications to endoscopy
* No porphyria
* No hypersensitivity to porphyrins
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* See Disease Characteristics
* More than 4 weeks since prior chemotherapy
* No concurrent chemotherapy
Endocrine therapy
* Not specified
Radiotherapy
* See Disease Characteristics
* More than 4 weeks since prior radiotherapy
* No concurrent radiotherapy
Surgery
* Not specified
Other
* No concurrent photosensitizing agents (e.g., tetracyclines, sulfonamides, phenothiazines, sulfonylureas, hypoglycemic agents, thiazide diuretics, and griseofulvin)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00060268
Study Brief:
Protocol Section:
NCT00060268