Post-Operative Adjuvant Concurrent Chemoradiotherapy For High Risk Oral Cavity Squamous Cell Carcinoma Patients
NCT ID: NCT00201383
Last Updated: 2005-09-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
161 participants
INTERVENTIONAL
1999-10-31
2009-08-31
Brief Summary
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Detailed Description
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Chemotherapy has been added in the hope to improve this situation. Induction and adjuvant chemotherapy has resulted in a decrease in the appearance of systemic metastases in most trials, but has not improved locoregional control and survival.
For cases with unresectable head and neck cancers, concurrent chemoradiotherapy appears to have improved locoregional control, disease-free survival, and possibly overall survival, as compared to radiotherapy alone. Bachaud et al. reported a randomized trial of postoperative cisplatin and radiotherapy vs. radiotherapy alone for patients with Stage III or IV head and neck cancer. Cisplatin was administered 50 mg weekly during radiotherapy. There was a significant improvement in locoregional control (70% vs. 55%) as well as overall survival (median 36m vs. 20m) in patients who received concurrent chemoradiotherapy. Al-Sarraf et al. also reported a phase II concurrent chemoradiotherapy trial, using cisplatin 100 mg/m2 every three weeks. Based on comparison with similar patients treated in a prior RTOG trial, they conclude that postoperative radiotherapy with concurrent cisplatin may improve locoregional control rates10. The superiority of adjuvant concurrent chemoradiotherapy (CCRT) to RT alone or sequential adjuvant RT and chemotherapy has been further confirmed in an analysis of data of RTOG 85-03 and RTOG 88-24. Comparing high-risk patients of RTOG 85-03 with prognostically similar patients from RTOG 88-24, the data suggest that sequential surgery, RT, and chemotherapy produced better locoregional control than surgery plus RT, but that surgery followed by CCRT produced even higher locoregional control. Independent of the differences in the amount of RT delivered, the Cox proportional hazards model suggests that the addition of CCRT resulted in a 50% decrease in locoregional relapse rates compared with surgery plus postoperative RT with no chemotherapy. The reduction in mortality was 18%.
Although CCRT may be better than RT alone or sequential treatment, the 3 year survival in both adjuvant CCRT studies were only around 50%. Is more aggressive treatment warranted? Tolerance to CCRT is a major concern. In the French study, severe acute toxicity occurred in 18% of RT only patients and 41% of patients received CCRT. In the RTOG 88-24 trial, severe and life-threatening toxicities occurred in 20% and 12% of patients, respectively; the most common drug-related toxicities were leukopenia, anemia, nausea, and vomiting . Theoretically, to optimize CCRT, continuous presence of chemotherapeutic drug or drug effect is necessary to maximize the effect of radiosensitization. For radiosensitization purpose, daily chemotherapy may be better than weekly and weekly may be better than tri-weekly. French study used weekly cisplatin with a dose of 30 mg/m2. RTOG 88-24 used different treatment dose and schedule 100 mg/m2 of cisplatin on radiotherapy days 1, 23 and 43. We choose weekly for convenience and hope this can increase the recruitment of patients. In the pilot study, we observed a remarkable toxicity with this treatment schedule. Considering the remarkable toxicity reported and our preliminary experience, more drugs, higher dosage, or extended schedule may not be justified.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Interventions
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cisplatin
Eligibility Criteria
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Inclusion Criteria
buccal mucosa upper lip (140.3) lower lip (140.4) cheek (145.0) retromolar area (145.6) bucco-alveolar sulci upper and lower (145.1) oral tongue dorsum (141.1) lateral border (141.2) inferior surface (141.3)
With any one of the risk factors of recurrence listed below:
Nodal extracapsular spread of disease (ECS) Number of positive node \> 2 Perineural involvement Lymphovascular emboli/permeation in resected surgical specimen Histologically positive surgical margin
Exclusion Criteria
\-
ALL
No
Sponsors
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National Taiwan University Hospital
OTHER
Changhua Christian Hospital
OTHER
China Medical University Hospital
OTHER
Buddhist Tzu Chi General Hospital
OTHER
Mackay Memorial Hospital
OTHER
Koo Foundation Sun Yat-Sen Cancer Center
OTHER
Chi Mei Medical Hospital
OTHER
Kaohsiung Veterans General Hospital.
OTHER
National Health Research Institutes, Taiwan
OTHER
Principal Investigators
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Mow-Ming Hsu, MD
Role: STUDY_CHAIR
National Taiwan University Hospital
Locations
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National Taiwan University Hospital
Taipei, , Taiwan
Countries
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Related Links
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Related Info
Other Identifiers
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T2399
Identifier Type: -
Identifier Source: org_study_id