A Phase 2 interventional study of Reduced Target Delineation and Radiation Doses in Nasopharyngeal Carcinoma, sponsored by Xiayun He, MD. Completed at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2019-12-16.
Sponsored by Xiayun He, MD · Phase 2, Interventional, and Treatment
To determine the efficacy and safety of sequential chemoradiotherapy with regimen of docetaxel, cisplatin and fluorouracil and reduced target delineation and radiation doses IMRT for patients with locoregionally advanced nasopharyngeal carcinoma
Although concurrent chemoradiation is the standard treatment modality for locally advanced nasopharyngeal carcinoma (NPC), high incidences of distant metastases and severe treatment related toxicities have become an obstacle to be overcome. Besides, a common problem in locally advanced NPC is the narrow gap between the tumor and critical normal structures, which makes dose optimization difficult. Considering that significant tumor shrinkage may occur during induction chemotherapy, and incidences of distant metastases may be reduced by adjuvant chemotherapy, this study was designed to explore the efficacy and safety of sequential chemoradiotherapy with regimen of docetaxel, cisplatin and fluorouracil and reduced target delineation and radiation doses IMRT for patients with locoregionally advanced NPC.
Absolute neutrophil count (ANC) >= 1.5 * 109/l Platelets count >= 100 * 109/l Hemoglobin >= 10 g/dl AST and ALT \<= 2.5 times institutional upper limit of normal (ULN) Total bilirubin \<= 1.5 times institutional ULN Creatinine clearance >= 50 ml/min Serum creatine \<= 1 times ULN
Exclusion Criteria:
All patients were assigned to receive induction chemotherapy (IC) followed by IMRT with adjuvant chemotherapy (AC). IMRT was administered 2 weeks after IC, and AC was administered 1 month after IMRT. IC or AC (TPF regimen) comprised docetaxel (60 mg/m2/day, day 1), cisplatin (25 mg/m2/day, days 1-3), and 5-fluorouracil (500 mg/m2/day with a 120-h infusion) administered once every 3 weeks for two cycles. During radiotherapy, involved retropharyngeal lymph nodes and intracavity lesions of the primary tumor were delineated according to the post-IC volume, whereas the remainder of the involved tissues (eg, pterygopalatine fossa) of the primary tumor were delineated according to the pre-IC volume of the primary tumor as shown by MRI. Post-IC volumes of involved neck lymph nodes were used for delineation. The prescribed dose was 66 Gy to tumors above the slices of skull base or below the orapharynx with less than 5 mm retropharyngeal lymph nodes, or 70.4 Gy to tumors in other slices.
Radiation: Reduced Target Delineation and Radiation Doses
The target volumes were delineated according to the treatment protocol defined as follows: the GTV of the primary tumor (GTV-P) included retropharyngeal lymph nodes, considering the common phenomena of integration, and the rest involved lymph nodes that were defined as GTV-N. For the GTV-P, involved retropharyngeal lymph nodes and intracavity lesions were delineated according to the post-IC volume, whereas the remainder of the involved tissues (eg, pterygopalatine fossa) were delineated according to the pre-IC volume of the primary lesion as shown by MRI. Post-IC volumes of involved neck lymph nodes were used for GTV-N delineation. The prescribed dose was 66 Gy to tumors above the slices of skull base or below the orapharynx with less than 5 mm retropharyngeal lymph nodes, or 70.4 Gy to tumors in other slices.
Also known as: Drug: TPF regimen comprised docetaxel (60 mg/m2/day, day 1), cisplatin (25 mg/m2/day, days 1-3), and 5-fluorouracil (500 mg/m2/day with a 120-h infusion)
Progression-free survival
The time from date of treatment until date of first documented disease progression or death from any cause, assessed up to 5 years.
Time frame: up to 5 years
Local recurrence-free survival
The time from date of treatment until date of first documented disease recurrence at a local site, assessed up to 5 years.
Time frame: up to 5 years
Regional recurrence-free survival
The time from date of treatment until date of first documented disease recurrence at a regional site, assessed up to 5 years.
Time frame: up to 5 years
Overall survival
The time from date of treatment until date of death due to any cause, assessed up to 5 years.
Time frame: up to 5 years
Distant metastasis-free survival
The time from date of treatment until date of first documented distant metastasis, assessed up to 5 years.
Time frame: up to 5 years
Locoregional failure patterns
The failures were categorized as occurring inside or outside the high dose target volume, depending on the location of Vrecur: "in field" if 95% of Vrecur was within the 95% isodose; "marginal" if 20% to 95% of Vrecur was within the 95% isodose, or "outside" if less than 20% of Vrecur was inside the 95% isodose.
Time frame: up to 5 years
Number of participants with acute toxicities
Number of participants with acute toxicities occurred during the chemoradiotherapy according to CTCAE4.0
Time frame: during treatment
Number of participants with late toxicities
Number of participants with late toxicities occurred from 3 months after completion of radiotherapy to last follow-up visit according to Radiation Therapy Oncology Group radiation morbidity scoring criteria.
Time frame: up to 5 years
Changes of tumor volume
Changes of tumor volume before and after induction chemotherapy
Time frame: 2 weeks after completion of induction chemotherapy
Relationship between treatment failure and dose received by target
Relationship between treatment failure and dose received by target
Time frame: up to 5 years
Plan to share: No
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Xiayun He, MD