Hypofractionated Radiotherapy and Concurrent Cisplatin for Head and Neck Cancer
HIPOCP
1 other identifier
interventional
20
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2015
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2015
CompletedFirst Submitted
Initial submission to the registry
April 24, 2017
CompletedFirst Posted
Study publicly available on registry
June 21, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2019
CompletedJanuary 19, 2018
June 1, 2017
4.7 years
April 24, 2017
January 17, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (2)
Quality of life according to the EORTC C30 questionaire and EORTC H&N 35 (evaluated together)
up to 18 months from treatment
Response rate
up to 4 months after patient accrual
Study Arms (1)
Hypofractionated chemoradiation
EXPERIMENTAL20 fractions of 275cGy and concomitant weekly cisplatin 35mg/m2 x 4 cycles
Interventions
20 fractions of 275cGy 5 days/week
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Other oncologic treatment before
- Distant metastasis
- History of previous malignancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 30352576DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 24, 2017
First Posted
June 21, 2017
Study Start
January 1, 2015
Primary Completion
August 31, 2019
Study Completion
August 31, 2019
Last Updated
January 19, 2018
Record last verified: 2017-06
Data Sharing
- IPD Sharing
- Will not share