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Completed

NCT Number: NCT03389295

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

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

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Key information

Conditions

Nasopharyngeal Carcinoma Carcinoma Head and Neck Neoplasms Nasopharyngeal Diseases Nasopharyngeal Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Pharyngeal Diseases Pharyngeal Neoplasms Stomatognathic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Histopathologically proven nasopharyngeal carcinoma (WHO type 2 or 3)
  • Stage Ⅲ-ⅣB disease (AJCC/UICC 2010)
  • KPS more than 70
  • Life expectancy of more than 6 months
  • Signed written informed consent
  • 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

  • Evidence of distant metastasis
  • Prior chemotherapy or anti-cancer biologic therapy for any type of cancer, or prior radiotherapy to the head and neck region
  • Other previous or concomitant cancer, except for in situ cervical cancer and cutaneous basal cell carcinoma
  • Pregnant or breast-feeding females, or females and males of childbearing potential not taking adequate contraceptive measures
  • 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

Treatment and study plan

Reduced Target Delineation and Radiation Doses

Radiation

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.

Other names: 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)

Primary outcomes

  1. Progression-free survival

    Time frame: up to 5 years

    The time from date of treatment until date of first documented disease progression or death from any cause, assessed up to 5 years.

Secondary outcomes

  1. Local recurrence-free survival

    Time frame: up to 5 years

    The time from date of treatment until date of first documented disease recurrence at a local site, assessed up to 5 years.

  2. Regional recurrence-free survival

    Time frame: up to 5 years

    The time from date of treatment until date of first documented disease recurrence at a regional site, assessed up to 5 years.

  3. Overall survival

    Time frame: up to 5 years

    The time from date of treatment until date of death due to any cause, assessed up to 5 years.

  4. Distant metastasis-free survival

    Time frame: up to 5 years

    The time from date of treatment until date of first documented distant metastasis, assessed up to 5 years.

  5. Locoregional failure patterns

    Time frame: up to 5 years

    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.

  6. Number of participants with acute toxicities

    Time frame: during treatment

    Number of participants with acute toxicities occurred during the chemoradiotherapy according to CTCAE4.0

  7. Number of participants with late toxicities

    Time frame: up to 5 years

    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.

  8. Changes of tumor volume

    Time frame: 2 weeks after completion of induction chemotherapy

    Changes of tumor volume before and after induction chemotherapy

  9. Relationship between treatment failure and dose received by target

    Time frame: up to 5 years

    Relationship between treatment failure and dose received by target

Sponsors and collaborators

Lead sponsor

Xiayun He, MD

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2019
Study completion
2019
First posted
Jan 3, 2018
Registry last updated
Dec 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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