P53 Gene Combined With Radio- and Chemo-therapy in Treatment of Unresectable Locally Advanced Head and Neck Cancer

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2018-12-31

Brief Summary

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The objectives of this study are to investigate the efficacy and safety of rAd-p53 gene combined with radio- and chemo-therapy vs. radio- and chemo- therapy only in treatment of unresectable, locally advanced head and neck cancer. This is a phase 2, open labeled, and active-controlled study.

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Detailed Description

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To evaluate benefits of rAd-p53) gene therapy combined with radio- and chemo-therapy in treatment of unresectable, locally advanced head and neck cancer, total of 60 patients with above condition will be randomly assigned to two groups: the experiment group (EG) and the control group (CG). The EG received multi-point injections of rAd-p53 into tumor on day 1, 8 and 15 at a dose of 2 × 10\^12 viral particles (VP) in a 21-days cycle. Both EG and CG were given radiotherapy at a total dose of 60 Gy and chemotherapy (Cisplatin 100 mg/m2 IV on days 1 plus paclitaxel 30 mg/m2 IV on day 1, 8 and 15). The patients will be treated until disease progression, withdrawal from study, or untolerated adverse events. study endpoints are efficacy (Progression-free survival, overall survival) and safety variables.

Conditions

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Advanced Head and Neck Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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rAd-p53 plus radiation and chemotherapy

rAd-p53 tumor injection combined with radio- and chemo-therapy.

Group Type EXPERIMENTAL

rAd-p53

Intervention Type DRUG

multi-point injections of rAd-p53 into tumor on day 1, 8 and 15 at a dose of 2 × 10\^12 viral particles (VP) in a 21-days cycle.

radiation

Intervention Type RADIATION

radiation therapy will be given at a total dose of 60 Gy by 2.0 Gy/fraction, daily Monday-Friday for 6 weeks.

Cisplatin

Intervention Type DRUG

Cisplatin 100 mg/m2 IV on days 1 plus paclitaxel 30 mg/m2 IV on day 1, 8 and 15

radiation and chemotherapy

radiation combined with chemotherapy

Group Type ACTIVE_COMPARATOR

radiation

Intervention Type RADIATION

radiation therapy will be given at a total dose of 60 Gy by 2.0 Gy/fraction, daily Monday-Friday for 6 weeks.

Cisplatin

Intervention Type DRUG

Cisplatin 100 mg/m2 IV on days 1 plus paclitaxel 30 mg/m2 IV on day 1, 8 and 15

Interventions

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rAd-p53

multi-point injections of rAd-p53 into tumor on day 1, 8 and 15 at a dose of 2 × 10\^12 viral particles (VP) in a 21-days cycle.

Intervention Type DRUG

radiation

radiation therapy will be given at a total dose of 60 Gy by 2.0 Gy/fraction, daily Monday-Friday for 6 weeks.

Intervention Type RADIATION

Cisplatin

Cisplatin 100 mg/m2 IV on days 1 plus paclitaxel 30 mg/m2 IV on day 1, 8 and 15

Intervention Type DRUG

Other Intervention Names

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p53 gene therapy chemotherapy: cisplatin

Eligibility Criteria

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Inclusion Criteria

1. histopathologically diagnosed head and neck cancer;
2. unresectable, locally advanced;
3. 18 years or older;
4. with an Eastern Cooperative Oncology Group (ECOG) score of 0-2;
5. with normal tests of hemogram, blood coagulation, liver and kidney function; 6.signed the informed consent form.

Exclusion Criteria

1. Serious blood coagulation disorder, bleeding tendency, platelet \< 6 \* 1000000000/L;
2. have serious heart, lung function abnormalities or severe diabetes patients;
3. active infection;
4. severe atherosclerosis;
5. AIDS patients;
6. serious thrombotic or embolic events within 6 months;
7. renal insufficiency requiring hemodialysis or peritoneal dialysis;
8. pregnant or lactating women;
9. mental disorder or disease.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No