Tissue-of-origin Directing Therapy in Patients With Cancer of Unknown Primary

NCT03278600 | Completed Phase 3

• 1 other identifier: Fudan CUP-001
• Study Type: interventional
• Target: 182
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to evaluate the value of tissue-of-origin (ORIGIN-PanCA○R) profiling in predicting primary site and directing therapy in patients with cancer of unknown primary.

Conditions

Cancer of Unknown Primary Site

Outcome Measures

Primary Outcomes (1)

• progression free survival

  6 months

Secondary Outcomes (4)

• overall response rate

  2 months

• overall survival

  12 months

• Adverse Events

  2 months

• biomarker analysis

  6 months

Study Arms (2)

site-specific therapy

EXPERIMENTAL

standard treatments of sites of origin

Genetic: tissue-of-origin (ORIGIN-PanCA○R) profiling

standard empiric chemotherapy

ACTIVE COMPARATOR

standard empiric chemotherapy

Genetic: tissue-of-origin (ORIGIN-PanCA○R) profiling

Interventions

tissue-of-origin (ORIGIN-PanCA○R) profiling GENETIC

90-gene assay to predict the primary tumor site

site-specific therapy; standard empiric chemotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• had a diagnosis of cancer of unknown primary (CUP) after a standard evaluation (medical history, physical examination, blood counts, chemistry profile, chest/abdomen computed tomography scans, positron emission tomography scan, and directed evaluation of all symptomatic areas). Patients were required to have one of the following histologies: adenocarcinoma, poorly differentiated neoplasms, poorly differentiated carcinoma, squamous carcinoma. Sufficient archived biopsy tissue from a surgical or core needle biopsy was required to perform the molecular profiling assay. Eastern Cooperative Oncology Group performance status of 0 to 2; no previous systemic therapy; measurable or evaluable disease (RECIST); and adequate organ function.

You may not qualify if:

• carcinoma limited to single site which can be potentially cured by surgery of radiotherapy.patients with symptomatic brain metastases, active clinical severe infection

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Cancer Hospital

Shanghai, 200032, China

Location

Related Publications (1)

• Liu X, Zhang X, Jiang S, Mo M, Wang Q, Wang Y, Zhou L, Hu S, Yang H, Hou Y, Chen Y, Lu X, Wang Y, Zhou X, Li W, Chang C, Yang X, Chen K, Cao J, Xu Q, Sun Y, Luo J, Luo Z, Hu X. Site-specific therapy guided by a 90-gene expression assay versus empirical chemotherapy in patients with cancer of unknown primary (Fudan CUP-001): a randomised controlled trial. Lancet Oncol. 2024 Aug;25(8):1092-1102. doi: 10.1016/S1470-2045(24)00313-9. Epub 2024 Jul 25.

  PMID: 39068945 DERIVED

MeSH Terms

Conditions

Neoplasms, Unknown Primary

Condition Hierarchy (Ancestors)

Neoplasm Metastasis; Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

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: Professor

Model Details: Tissue-of-origin test

Study Record Dates

• First Submitted: September 8, 2017
• First Posted: September 11, 2017
• Study Start: September 18, 2017
• Primary Completion: March 18, 2021
• Study Completion: March 18, 2021
• Last Updated: January 24, 2022

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)