HIPOCP: Hypofractionated Radiotherapy and Concurrent Cisplatin for Head and Neck Cancer

• Sponsor: Barretos Cancer Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03194061
• Collaborator: (none)
• Enrollment: 20
• Arm: 1
• Anticipated Duration (Months): 56

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Radiotherapy; Complications	Radiation: Hypofractionated Radiotherapy; Drug: Weekly cisplatin	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Hypofractionated Radiotherapy and Concurrent Cisplatin for Locally Advanced Head and Neck Cancer: A Feasibility Trial
• Actual Study Start Date: Jan 1, 2015
• Anticipated Primary Completion Date: Aug 31, 2019
• Anticipated Study Completion Date: Aug 31, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. To evaluate the rate of patient who could complete the treatment. [up to 5 years after patient accrual]

   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.

2. To evaluate the rate of participants with treatment-related adverse events [up to 5 years after patient accrual]

   as assessed by investigators using the CTCAE v4.0 criteria

Secondary Outcome Measures

1. Quality of life according to the EORTC C30 questionaire and EORTC H&N 35 (evaluated together) [up to 18 months from treatment]

   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.

2. Response rate [up to 4 months after patient accrual]

   as determined by investigators using RECIST v1.1 criteria

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Barretos Cancer Hospital
• ClinicalTrials.gov Identifier: NCT03194061
• Other Study ID Numbers: HIPO CP.
• First Posted: Jun 21, 2017
• Last Update Posted: Jan 19, 2018
• Last Verified: Jun 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Barretos Cancer Hospital: chemotherapy; complication
• Additional relevant MeSH terms: Head and Neck Neoplasms; Cisplatin

Study Results

No Results Posted as of Jan 19, 2018