Reduced Target Delineation and Radiation Doses Chemoradiotherapy for Patients With Locoregionally Advanced Nasopharyngeal Carcinoma

Nasopharyngeal Carcinoma Clinical Trial

Official title:

Sequential Chemoradiotherapy With Reduced Target Delineation and Radiation Doses During Radiotherapy for Patients With Locoregionally Advanced Nasopharyngeal Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03389295
• Other study ID #: TPF-Shanghai
• Status: Completed
• Phase: Phase 2
• Start date: January 2010
• Est. completion date: April 2019

Study information

• Verified date: December 2019
• Source: Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: April 2019
• Est. primary completion date: April 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Histopathologically proven nasopharyngeal carcinoma (WHO type 2 or 3)

2. Stage ?-?B disease (AJCC/UICC 2010)

3. KPS more than 70

4. Life expectancy of more than 6 months

5. Signed written informed consent

6. Adequate organ function including the following:

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:

1. Evidence of distant metastasis

2. Prior chemotherapy or anti-cancer biologic therapy for any type of cancer, or prior radiotherapy to the head and neck region

3. Other previous or concomitant cancer, except for in situ cervical cancer and cutaneous basal cell carcinoma

4. Pregnant or breast-feeding females, or females and males of childbearing potential not taking adequate contraceptive measures

5. Presence of an uncontrolled concomitant illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia

Related Conditions & MeSH terms

• Carcinoma
• Nasopharyngeal Carcinoma

Intervention

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.

Locations

Country	Name	City	State
China	Fudan University Shanghai Cancer Center	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Xiayun He, MD

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	up to 5 years
Secondary	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.	up to 5 years
Secondary	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.	up to 5 years
Secondary	Overall survival	The time from date of treatment until date of death due to any cause, assessed up to 5 years.	up to 5 years
Secondary	Distant metastasis-free survival	The time from date of treatment until date of first documented distant metastasis, assessed up to 5 years.	up to 5 years
Secondary	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.	up to 5 years
Secondary	Number of participants with acute toxicities	Number of participants with acute toxicities occurred during the chemoradiotherapy according to CTCAE4.0	during treatment
Secondary	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.	up to 5 years
Secondary	Changes of tumor volume	Changes of tumor volume before and after induction chemotherapy	2 weeks after completion of induction chemotherapy
Secondary	Relationship between treatment failure and dose received by target	Relationship between treatment failure and dose received by target	up to 5 years