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

Primary Purpose

Radiotherapy; Complications

Status

Unknown status

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Hypofractionated Radiotherapy

Weekly cisplatin

About this trial

This is an interventional treatment trial for Radiotherapy; Complications focused on measuring chemotherapy, complication

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Hypofractionated chemoradiation

Arm Description

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

Outcomes

Primary Outcome Measures

To evaluate the rate of patient who could complete the treatment.

The treatment is considered completed when patients receive at least 90% of radiation dose (49,5Gy) with a cumulative cisplatin dose of 105mg/m2 or more (3 of 4 cycles) and the treatment duration is inferior to 35 consecutive days.

To evaluate the rate of participants with treatment-related adverse events

as assessed by investigators using the CTCAE v4.0 criteria

Secondary Outcome Measures

Quality of life according to the EORTC C30 questionaire and EORTC H&N 35 (evaluated together)

Frequency and intensity of symptoms as described by patients before treatment (baseline), at the end of treatment, 1 month, 7 months and after 1 year following the treatment.

Response rate

as determined by investigators using RECIST v1.1 criteria

Full Information

NCT ID

NCT03194061

First Posted

April 24, 2017

Last Updated

January 17, 2018

Sponsor

Barretos Cancer Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03194061

Brief Title

Hypofractionated Radiotherapy and Concurrent Cisplatin for Head and Neck Cancer

Acronym

HIPOCP

Official Title

Hypofractionated Radiotherapy and Concurrent Cisplatin for Locally Advanced Head and Neck Cancer: A Feasibility Trial

Study Type

Interventional

2. Study Status

Record Verification Date

June 2017

Overall Recruitment Status

Unknown status

Study Start Date

January 1, 2015 (Actual)

Primary Completion Date

August 31, 2019 (Anticipated)

Study Completion Date

August 31, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Barretos Cancer Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Radiotherapy; Complications

Keywords

chemotherapy, complication

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Hypofractionated chemoradiation

Arm Type

Experimental

Arm Description

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

Intervention Type

Radiation

Intervention Name(s)

Hypofractionated Radiotherapy

Intervention Description

20 fractions of 275cGy 5 days/week

Intervention Type

Drug

Intervention Name(s)

Weekly cisplatin

Intervention Description

Concomitant weekly cisplatin 35mg/m2 x 4 weeks

Primary Outcome Measure Information:

Title

To evaluate the rate of patient who could complete the treatment.

Description

Time Frame

up to 5 years after patient accrual

Title

To evaluate the rate of participants with treatment-related adverse events

Description

as assessed by investigators using the CTCAE v4.0 criteria

Time Frame

up to 5 years after patient accrual

Secondary Outcome Measure Information:

Title

Quality of life according to the EORTC C30 questionaire and EORTC H&N 35 (evaluated together)

Description

Frequency and intensity of symptoms as described by patients before treatment (baseline), at the end of treatment, 1 month, 7 months and after 1 year following the treatment.

Time Frame

up to 18 months from treatment

Title

Response rate

Description

as determined by investigators using RECIST v1.1 criteria

Time Frame

up to 4 months after patient accrual

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials: