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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03367884
Other study ID # TJHPC-01
Secondary ID
Status Not yet recruiting
Phase N/A
First received December 5, 2017
Last updated December 10, 2017
Start date January 1, 2018
Est. completion date January 1, 2028

Study information

Verified date November 2017
Source Tianjin Medical University Cancer Institute and Hospital
Contact Yuansheng Duan, MD
Phone +86 022 23340123
Email duanyuansheng89@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

At the time of diagnosis, approximately 60%-80% of patients with hypopharyngeal cancer are found with cervical lymph node metastasis. Cervical nodal metastasis is an important prognostic factor in hypopharyngeal cancer. Induction chemotherapy is frequently used in advanced hypopharynx cancer. However, sometimes CR was obtained at the tumor's primary site but not in the palpable lymph nodes in the neck, the large cervical lymph node metastasis poorly responded to induction chemotherapy in a considerable percentage of patients. At present, patients with primary tumor achieved CR preferred to receive definitive radiotherapy no matter cervical lymph node metastasis SD or progression. But, radiotherapy was poor effective to the big cervical lymph node metastasis, because the inner of big cervical lymph node metastasis was hypoxic and necrosis. The investigators conducted a prospective, randomised trial to compare neck dissection with definitive radiotherapy for advanced hypopharyngeal cancer cervical lymph node metastasis with poor response to induction chemotherapy.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 120
Est. completion date January 1, 2028
Est. primary completion date January 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

1. Ability to understand and the willingness to sign a written informed consent document

2. Age= 18 and= 75 years

3. Histological/ cytological/ Imaging examination proven hypopharyngeal squamous-cell carcinoma in preoperative assessment

4. Advanced hypopharyngeal cancer with metastatic cervical lymph node more than 2cm in diameter

5. EPOG=1,KPS= 70

6. No contraindication of surgery and radiotherapy

7. No serious disease history of the heart, liver, kidney, lung and other important organs

8. Expected survival period= 12 months

9. Good compliance

Exclusion Criteria:

1. Inability to provide an informed consent

2. Other malignancy tumor history,(except for cured skin basal cell carcinoma and papillary thyroid carcinoma)

3. Serious cardiovascular, liver, respiratory, kidney and neurologic and psychiatric disease with clinical symptoms

4. The patient has received prior surgery or radiotherapy (except for biopsy)

5. The patient has received chemotherapy or immunotherapy

6. Pregnant or lactating women

7. Other disease requiring simultaneous surgery or radiotherapy

Study Design


Intervention

Procedure:
Neck dissection followed by radiotherapy(50Gy) according to risk factors
Neck dissection followed by radiotherapy(50Gy) according to risk factors
Radiation:
Definitive radiotherapy
Definitive radiotherapy (70Gy)

Locations

Country Name City State
China Tianjin Medical University Cancer Institute and Hospital Tianjin Tianjin

Sponsors (3)

Lead Sponsor Collaborator
Tianjin Medical University Cancer Institute and Hospital Tianjin Medical University General Hospital, Tianjin Medical University Second Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Neck control rates The percentage of patients without cervical lymph node metastasis 2 years
Secondary Disease-free survival The proportion of patients did not find clear evidence of recurrence or metastasis 1 year
Secondary Disease-free survival The proportion of patients did not find clear evidence of recurrence or metastasis 2 years
Secondary Disease-free survival The proportion of patients did not find clear evidence of recurrence or metastasis 3 years
Secondary Disease-free survival The proportion of patients did not find clear evidence of recurrence or metastasis 5 years
Secondary Overall survival The proportion of patients who survived 3 years
Secondary Overall survival The proportion of patients who survived 5 years
Secondary Quality of life(QOL) QLQ-C30 Evaluated by the European Organization for Research and Treatment of Cancer(EORTC)QLQ-C30 1 year
Secondary Quality of life(QOL) QLQ-HN35 Evaluated by the European Organization for Research and Treatment of Cancer(EORTC) QLQ-HN35 1 year
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