Adjuvant Chemoradiation With Weekly Oxaliplatin in Resected Head and Neck Cancer
|ClinicalTrials.gov Identifier: NCT00256308|
Recruitment Status : Unknown
Verified May 2010 by University of California, Irvine.
Recruitment status was: Active, not recruiting
First Posted : November 21, 2005
Last Update Posted : May 7, 2010
Oxaliplatin-containing regimens have been safely and successfully used in combination with concurrent radiation in treatment of solid tumors such as rectal and esophageal cancers. The Lyon R0-04 phase II trial utilized the combination of Oxaliplatin, infusional 5FU and radiation in the treatment of rectal cancer. A total of 40 operable subjects were entered onto the study. Radiotherapy was delivered with A three-field technique to a dose of 50 Gy (total dose) over 5 weeks with a concomitant boost approach. Two cycles of chemotherapy were given synchronously on weeks 1 and 5, with Oxaliplatin 130 mg/m2 in day 1 followed by continuous infusion of fluorouracil 350 mg/mg2 and L-folinic acid 100mg/m2 for 5 days. Surgery was planned 5 weeks later. All subjects completed treatment without modification except one who experience grade 3-4 toxicity. Grade 3 toxicity was seen in seven subjects. Surgery was performed in all subjects after a mean interval time of 5 weeks. An objective clinical response was seen in 30 subjects (75%). Sphincter-saving surgery was possible in 26 subjects. No postoperative deaths occurred. In four subjects (10%), a reoperation was necessary (anastomotic fistula, n=2; pelvic abscess, n=2). In six cases the operative specimen was sterilized (15%), and in 12 cases (30%), only few residual cells were detected. Such a combined preoperative chemoradiotherapy and Oxaliplatin-containing regimen is well tolerated with no increase surgical toxicity. The good response rate observed warrants its use in further clinical trials.
The combination of oxaliplatin, 5FU, and radiation also have been used in a Phase I/II trial in esophageal cancer. In this particular trial, eligibility included therapeutically naïve esophageal cancer subjects with clinical disease stages II to IV. Initial doses and schedules for cycle 1 consisted of Oxaliplatin 85 mg/m2 on days 1, 15, and 29; continuous infusion of 5-FU 180 mg/m2 for 24 hours for 35 days; and RT 1.8 Gy in 28 fractions starting on day 8. At completion of cycle 1, eligible subjects could undergo an operation or begin cycle 2 without RT. Postoperative subjects were eligible for cycle 2. Stage IV subjects were allowed three cycles in the absence of disease progression. 38 subjects were treated (22 stage IV, 16 stage II-III). 38 eligible subjects received therapy: 22 non-invasively staged as IV and 16 non-invasively staged as IV and 16 non-invasively staged as II and III. 36 subjects completed cycle 1, 29 subjects started cycle 2, and 24 subjects completed cycle 2. The combined-modality therapy was well tolerated, but dose limiting toxicity (DLT) prevented Oxaliplatin and 5-FU escalation. No grade 4 hematologic toxicity was noted. Eleven grade 3 and two grade 4 clinical toxicities were noted in eight subjects. After cycle 1, 29 subjects (81%) had no cancer in the esophageal mucosa. 13 subjects underwent an operation with intent to resect the esophagus and 5 subjects (38%) exhibited pathologic complete responses. There was no surgical mortality. Only 1 subject developed post-operative tracheosphageal fistula.
The results of these trials described above indicated that combination of oxaliplatin and radiation is safe and efficacious and dose not compromise surgical wound healing, repair and clinical outcome.
|Condition or disease||Intervention/treatment||Phase|
|Head and Neck Cancer||Drug: Oxaliplatin Procedure: Radiation||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Adjuvant Chemoradiation With Weekly Oxaliplatin in Patients With High Risk Resected Squamous Cell Carcinoma of the Head and Neck Region|
|Study Start Date :||April 2005|
|Estimated Primary Completion Date :||December 2010|
|Estimated Study Completion Date :||December 2010|
- Assess the frequency and severity of toxicities [ Time Frame: 2 years ]
- Evaluate the 2 year locoregional control rate [ Time Frame: 2 years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00256308
|United States, California|
|Chao Family Comprehensive Cancer Center|
|Orange, California, United States, 92868|
|Principal Investigator:||Ignatius Ou, MD||Chao Family Comprehensive Cancer Center|