Efficacy Study of Genexol-PM and Cisplatin in Locally Advanced Head and Neck Cancer

• Sponsor: Seoul National University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT01689194
• Collaborator: Clinical Research Center for Solid Tumor, Korea (Other)
• Enrollment: 53
• Locations: 2
• Arm: 1
• Actual Duration (Months): 54.9
• Patients Per Site: 26.5
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

This clinical trial is Phase II trial for evaluating efficacy of induction chemotherapy using Genexol-PM + cisplatin for locally advanced head and neck cancer. The investigators try to evaluate response rate of Genexol-PM + cisplatin chemotherapy, and safety profile.

Condition or Disease	Intervention/Treatment	Phase
Locally Advanced Head and Neck Squamous Cell Carcinoma	Drug: genexolPM + cisplatin	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 53 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase II Study of Genexol-PM and Cisplatin as Induction Chemotherapy in Unresectable, Locally Advanced Head and Neck Squamous Cell Carcinoma (HNSCC)
• Actual Study Start Date: Feb 1, 2013
• Actual Primary Completion Date: Apr 1, 2016
• Actual Study Completion Date: Aug 31, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: genexolPM + cisplatin	Drug: genexolPM + cisplatin

Outcome Measures

Primary Outcome Measures

1. response rate [every 2 cycles, 6wk later after chemotherapy]

   RECIST

Secondary Outcome Measures

1. Locoregional control rate [every 3wk (every cycle)]

   NCI CTCAE

2. Quality of life [every 3wk (every cycle)]

   EORTC Q30; performance scale(activities) pain adverse event(appetite, sleep and so on)

3. safety [every 3wk (every cycle)]

   NCI CTCAE v3.0; disease or syndrome, pathologic funtion, sign or symptom, imjury or poisoning, anatomical abnormality, mental or behavioral dysfunction Neutropenia, leucopenia, thrombocytopenia, hepatotoxicity, renal toxicity

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• locally advanced head and neck squamous cell carcinoma

• oral cavity, oropharynx, hypopharynx, larynx

• measurable lesion

• unresectable

• age 18 or more

• ECOG 0 or 1

Exclusion Criteria:

• distant metastasis

• pregnancy

• prior chemotherapy or radiation therapy

• 2ndary malignancy

• other unfit medical condition

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul National University Hospital	Seoul		Korea, Republic of	110-744
2	Seoul National University Hospital	Seoul		Korea, Republic of

Sponsors and Collaborators

• Seoul National University Hospital
• Clinical Research Center for Solid Tumor, Korea

Investigators

• Principal Investigator: Se-Hoon Lee, MD PhD, Seoul National University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Se-Hoon Lee, professor, Seoul National University Hospital
• ClinicalTrials.gov Identifier: NCT01689194
• Other Study ID Numbers: CRCST-L-0007; H-1204-103-407
• First Posted: Sep 21, 2012
• Last Update Posted: Dec 8, 2020
• Last Verified: Dec 1, 2020

• Additional relevant MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck; Cisplatin

Study Results

No Results Posted as of Dec 8, 2020