Ph 2 Intensification Regimen for Previously Untreated, Resectable, Advanced Squamous Cell Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00566540|
Recruitment Status : Unknown
Verified October 2016 by Enver Ozer, Ohio State University Comprehensive Cancer Center.
Recruitment status was: Active, not recruiting
First Posted : December 3, 2007
Last Update Posted : October 21, 2016
RATIONALE: Drugs used in chemotherapy, such as cisplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination chemotherapy together with radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving these treatments after surgery may kill any tumor cells that remain after surgery.
PURPOSE: This phase II trial is studying how well giving cisplatin and paclitaxel together with radiation therapy and surgery works in treating patients with advanced cancer of the oral cavity, oropharynx, or hypopharynx that can be removed by surgery.
|Condition or disease||Intervention/treatment||Phase|
|Head and Neck Cancer||Drug: Cisplatin Drug: Paclitaxel Radiation: Intensity-Modulated Radiation Therapy (IMRT) External Beam Radiation Procedure: Triple endoscopy and biopsy||Phase 2|
- Determine the feasibility of a new intensification regimen comprising cisplatin and paclitaxel in combination with radiotherapy and surgery in patients with resectable advanced squamous cell carcinoma of the oral cavity, oropharynx, or hypopharynx.
- Assess the disease-free interval and failure sites in patients treated with this regimen.
- Correlate molecular markers with treatment outcome in these patients.
- Correlate quality of life with treatment outcome in these patients.
- Determine the frequency and severity of toxicities of this regimen in these patients.
- Evaluate treatment completion in these patients.
- Preoperative therapy (weeks 1 and 2): Patients receive cisplatin IV over 2 hours on days 1-3. Patients also undergo intensity-modulated external beam radiotherapy once daily on days 1-5 and 8-12.
- Surgery (week 3): Patients undergo surgical resection of the primary tumor (with or without neck dissection) and intraoperative boost radiotherapy.
- Postoperative therapy (weeks 7-10): Patients receive cisplatin IV over 2 hours on days 1-3 and 22-24 and paclitaxel IV over 3 hours on days 1, 8, 15, and 22. Patients also undergo intensity-modulated external beam radiotherapy on days 1-5, 8-12, 15-19, and 22-26.
Patients undergo blood and tissue sample collection at baseline, in weeks 3, 7-10, and 14, and then periodically thereafter for biomarker correlative studies.
Quality of life is assessed at baseline, at 3, 6, and 12 months after completion of treatment, and then annually thereafter.
After completion of study treatment, patients are followed every 2 months for 1 year and then periodically thereafter.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Intensification Regimen for Previously Untreated, Resectable, Advanced Squamous Cell Carcinoma of the Oral Cavity, Oropharynx, and Hypopharynx: Incorporation of Intensity Modulated Radiotherapy and Submandibular Gland Transfer to Minimize Treatment Morbidity; Correlative Imaging/Molecular Markers.|
|Study Start Date :||December 2007|
|Actual Primary Completion Date :||February 2010|
Experimental: Treatment (neoadjuvant, adjuvant chemotherapy and radiation)
PREOPERATIVE:Patients receive cisplatin IV over 2 hours three times weekly in week 1 once daily(QD),5 days a week, in weeks 1-2.
SURGERY:Patients undergo triple endoscopy and biopsy with submandibular gland transfer in week 3.
INTRAOPERATIVE: Patients also undergo Intensity-Modulated Radiation Therapy (IMRT) External Beam Radiation.
POSTOPERATIVE: Patients receive paclitaxel IV over 3 hours in weeks 7-10 and cisplatin IV over 1-2 hours three times weekly in weeks 7 and 10. Patients also undergo Intensity-Modulated Radiation Therapy (IMRT) External Beam Radiation QD, 5 days a week, in weeks 7-10.
Patients will receive Cisplatin (30 mg/m2 i.v.) daily x 3 days in week 1.
Patients will receive Paclitaxel (45 mg/m2i.v.) infusion over 3 hours during weeks 7,8,9,10
Other Name: Taxol®
Radiation: Intensity-Modulated Radiation Therapy (IMRT) External Beam Radiation
Patients will receive Intensity-Modulated Radiation Therapy (IMRT) External Beam Radiation to tumor and involved regional nodes 20Gy over 10 daily (M-F) treatments (2 Gy Fractions with 6 millivolts photons)week 1 and 2.
Procedure: Triple endoscopy and biopsy
Resection of the primary tumor: Patients must have surgery performed according to the following surgical guidelines. The extent of the surgical resection will be dictated by the extent of the tumor at the time of initial evaluation. The primary lesion must be widely excised using accepted criteria for adequate excision depending on the region involved. All patients will undergo percutaneous endoscopic gastrostomy tube placement at the time of endoscopy and biopsies.
- Feasibility of treatment [ Time Frame: Up to one year ]
- Disease-free interval and failure sites [ Time Frame: Up to one year ]
- Correlation of molecular markers with treatment outcome [ Time Frame: Up to week 14 ]
- Correlation of quality of life with treatment outcome [ Time Frame: Up to one year ]
- Frequency and severity of toxicities [ Time Frame: Up to one year ]
- Treatment completion [ Time Frame: up to one year ]Patients are to be seen at Ohio State Medical center for a physical exam every 2 months for the first year.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00566540
|United States, Ohio|
|Ohio State University Medical Center|
|Columbus, Ohio, United States, 43210|
|Principal Investigator:||Enver Ozer, MD||Ohio State University|