Hypofractionated Radiotherapy and Concurrent Cisplatin for Head and Neck Cancer (HIPOCP)

Barretos Cancer Hospital

Status: Unknown

Conditions: Radiotherapy; Complications

Treatments: Drug: Weekly cisplatin; Radiation: Hypofractionated Radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03194061

HIPO CP.

Details and patient eligibility

About

The aim of this study is to evaluate the feasibility of hypofractionated radiation therapy and concomitant chemotherapy with cisplatin for locally advanced head and neck cancer in a high volume brazilian center.

Full description

To evaluate if concomitant cisplatin and hypofractionated radiation therapy wold be feasible in a brazilian population.

Patients eligibility criteria:

older than 18 years old Biopsy proven squamous cell carcinoma of oropharynx, larynx and hypopharynx. Stage III an IV, with no distant metastasis. ECOG performance status 0-2. Adequate renal and liver function. Good status for radical treatment

Treatment considered feasible if:

1. Patient receive at least 90% of radiation dose (18 of 20 fractions of 275cGy)
2. Patients receive at least 3 of 4 weekly cycles of cisplatin (35mg/m2)
3. Treatment length up to 35 days.
4. Grade 4 toxicity lower than 25%

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Biopsy proven squamous cell carcinoma of oropharynx, larynx and hypopharynx.
• Stage III an IV, with no distant metastasis.
• ECOG performance status 0-2.
• Adequate renal and liver function.
• Good status for radical treatment

Exclusion criteria

• Other oncologic treatment before
• Distant metastasis
• History of previous malignancy

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Hypofractionated chemoradiation

Experimental group

Description:

20 fractions of 275cGy and concomitant weekly cisplatin 35mg/m2 x 4 cycles

Treatment:

Radiation: Hypofractionated Radiotherapy

Drug: Weekly cisplatin