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

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

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.

Study Overview

• Status: Unknown
• Conditions: Radiotherapy; Complications
• Intervention / Treatment: Radiation: Hypofractionated Radiotherapy; Drug: Weekly cisplatin

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:

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%

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hypofractionated chemoradiation; 20 fractions of 275cGy and concomitant weekly cisplatin 35mg/m2 x 4 cycles	Radiation: Hypofractionated Radiotherapy; 20 fractions of 275cGy 5 days/week; Drug: Weekly cisplatin; Concomitant weekly cisplatin 35mg/m2 x 4 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	up to 5 years after patient accrual
To evaluate the rate of participants with treatment-related adverse events	as assessed by investigators using the CTCAE v4.0 criteria	up to 5 years after patient accrual

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	up to 18 months from treatment
Response rate	as determined by investigators using RECIST v1.1 criteria	up to 4 months after patient accrual

Collaborators and Investigators

• Sponsor: Barretos Cancer Hospital
• Investigators: Principal Investigator: Alexandre A Jacinto, MD, Barretos Cancer Hospital; Study Director: Andre Lopes Carvalho, Phd, Barretos Cancer Hospital; Study Chair: Luciano Souza Viana, Phd, Barretos Cancer Hospital; Study Chair: Pedro de Marchi, Barretos Cancer Hospital; Study Chair: Eronides Salustiano Batalha, Barretos Cancer Hospital

Publications and helpful links

General Publications

• Jacinto AA, Batalha Filho ES, Viana LS, De Marchi P, Capuzzo RC, Gama RR, Boldrini Junior D, Santos CR, Pinto GDJ, Dias JM, Canton HP, Carvalho R, Radicchi LA, Bentzen S, Zubizarreta E, Carvalho AL. Feasibility of concomitant cisplatin with hypofractionated radiotherapy for locally advanced head and neck squamous cell carcinoma. BMC Cancer. 2018 Oct 23;18(1):1026. doi: 10.1186/s12885-018-4893-5.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2015
• Primary Completion (Anticipated): August 31, 2019
• Study Completion (Anticipated): August 31, 2019

Study Registration Dates

• First Submitted: April 24, 2017
• First Submitted That Met QC Criteria: June 20, 2017
• First Posted (Actual): June 21, 2017

Study Record Updates

• Last Update Posted (Actual): January 19, 2018
• Last Update Submitted That Met QC Criteria: January 17, 2018
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: chemotherapy; complication
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Antineoplastic Agents; Cisplatin
• Other Study ID Numbers: HIPO CP.

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No