Stereotactic Boost and Short-course Radiation Therapy for Oropharynx Cancer (SHORT-OPC)
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|ClinicalTrials.gov Identifier: NCT04178174|
Recruitment Status : Recruiting
First Posted : November 26, 2019
Last Update Posted : February 21, 2021
|Condition or disease||Intervention/treatment||Phase|
|Head and Neck Cancer Oropharynx Cancer Human Papilloma Virus||Radiation: SABR boost and de-escalated chemoradiation Radiation: Standard chemoradiation||Phase 2|
Concurrent platinum-based chemoradiation remains the standard of care in locally advanced head and neck cancer. The current standard radiation regimen consists in a 7-week course of conventionally fractionated radiotherapy to the gross tumor volume (GTV), along with bilateral prophylactic neck irradiation to an elective dose of ~ 50 Gy in 2 Gy per fraction. In addition to being cumbersome, the current protracted daily radiation course is associated with high rates of acute and late toxicities and significant deterioration of patients' quality of life. In the light of the remarkably improved prognosis of the distinct subgroup of HPV-OPC, there is growing interest for treatment de-intensification strategies in contemporaneous OPC cohorts.
Stereotactic ablative radiotherapy (SABR) allows for ultra-precise delivery of ablative radiation dose over a small number of fractions, by combining sharp dose gradients with use of optimal image guidance. The increased conformity and reduced margins used in SABR can substantially reduce the dose to surrounding organs at risk and could therefore reduce toxicity. In addition, previous work has shown that an elective dose of 40 Gy in 2 Gy per fraction, in conjunction with chemotherapy, is sufficient for microscopic sterilisation of cancer cells and can translate into a reduction of toxicities.
The goal of this trial is to compare the efficacy and safety of short-course chemoradiation consisting in stereotactic boost to the gross tumor of 14 Gy in 2 fractions followed by de-esclalated chemoradiation (40 Gy in 20 fractions and concurrent 2 cycles of Cisplatin 100mg/m2) in human papilloma associated oropharynx cancer vs. the current standard 7-week course chemoradiation (70 Gy in 33 fractions with 2-3 cycles of Cisplatin 100mg/m2).
This is an open label randomized phase II trial with 2 planned interim safety (toxicity) analysis and 1 futility (locoregional control) analysis with go/no go decision to pursue the study based on probabilities of toxicities and LRC (Bayesian adaptive design). Patients will be randomized using a 1:1 ratio between the standard and the experimental arm and will be stratified by tumor stage. At the significance level of 0.2 and assuming the LRC rate of 90% for both experimental and control arms, 80% for the non-inferiority test with the margin of 10%, and 6% attrition rate, a total of 106 patients will be enrolled.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||106 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Stereotactic Boost and SHOrt-course Radiation Therapy for HPV-associated OroPharynx Cancer Trial: A Randomized Multicentric Phase II Trial|
|Actual Study Start Date :||February 23, 2020|
|Estimated Primary Completion Date :||December 2023|
|Estimated Study Completion Date :||December 2025|
Experimental: SABR boost and de-escalated chemoradiation
SABR boost of 14 Gy in 2 fractions to the GTV, immediately followed by de-escalated chemoradiation. De-escalated chemoradiation will consist in 40 Gy in 20 fractions with concurrent high dose Cisplatin (3-weekly, 100 mg/m2) for 2 cycles, aiming for a cumulative dose of 200 mg/m2.
Radiation: SABR boost and de-escalated chemoradiation
Stereotactic body radiotherapy boost to the gross tumor volume to a dose of 14 Gy in 2 fractions, followed by cisplatin-based chemoradiation to a dose of 40 Gy in 20 fractions
Active Comparator: Standard chemoradiation
The standard arm will consist of conventionally radiation to a dose of 70 Gy in 33 fractions concurrently with high dose Cisplatin (3-weekly, 100 mg/m2) for 2-3 cycles, aiming for a cumulative dose of ≥ 200 mg/m2.
Radiation: Standard chemoradiation
Standard Cisplatin-based chemoradiation to a dose of 70 Gy in 33 fractions
- Locoregional control [ Time Frame: 2 years after the end of chemoradiation ]Patient alive with locoregional control at 2 years after the end of chemoradiation
- Subacute toxicity [ Time Frame: Between 2 and 6 months after the end of chemoradiation ]Rate of grade ≥ 3 subacute toxicity
- Acute toxicity [ Time Frame: Less than 2 months after the end of chemoradiation ]Rate of grade ≥ 3 acute toxicity
- Late toxicity [ Time Frame: Between 6 months and 5-years after the end of chemoradiation ]Rate of grade ≥ 3 late toxicity
- OS [ Time Frame: At 2- and 5-years after the end of chemoradiation ]Overall survival
- PFS [ Time Frame: At 2- and 5-years after the end of chemoradiation ]Progression free survival
- Head and neck symptom burden [ Time Frame: At baseline, and 1-, 3-, 6-, 12- months post-treatment, and yearly from years 2-5 after the end of chemoradiation ]Patient-reported head and neck symptom burden as measured by the MD Anderson Symptom Inventory Head and Neck Cancer Module. The core and head and neck cancer specific symptoms are rated on a 0-10 scale to indicate the presence and severity of the symptoms. Lower scores represent better functioning and quality of life.
- Dysphagia [ Time Frame: At baseline, and 1-, 3-, 6-, 12- months post-treatment, and yearly from years 2-5 after the end of chemoradiation ]Patient-reported dysphagia as measured by the MD Anderson Dysphagia Index. Overall score ranges from 0 to 100, with higher score representing better functioning and quality of life.
- Time from treatment start to return to work [ Time Frame: Measured in days and reported at 2-years post-treatment ]Time from first day of treatment start to first day of return to work.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04178174
|Contact: Diane Trudelemail@example.com|
|Centre Hospitalier de l'Université de Montréal||Recruiting|
|Montreal, Quebec, Canada, H2X 1R6|
|Contact: Mom Phat 514-890-8000 ext 26906 firstname.lastname@example.org|
|Principal Investigator: Houda Bahig|
|Sub-Investigator: Phuc-Félix Nguyen-Tan|
|Study Chair:||Houda Bahig, MD PhD||Centre hospitalier de l'Université de Montréal (CHUM)|
|Study Chair:||Phuc-Felix Nguyen-Tan, MD||Centre hospitalier de l'Université de Montréal (CHUM)|
|Principal Investigator:||David Palma, MD PhD||Lawson Health Research Institute|
|Principal Investigator:||Jack Phan, MD PhD||M.D. Anderson Cancer Center|
|Principal Investigator:||Khalil Sultanem, MD||Montreal Jewish General Hospital|