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Trial Title:
Dose Escalation Using Hypoxia-adjusted Radiotherapy
NCT ID:
NCT06087614
Condition:
Head and Neck Squamous Cell Carcinoma
Conditions: Official terms:
Squamous Cell Carcinoma of Head and Neck
Hypoxia
Cisplatin
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
DE-HyART
Description:
The HSV delineation will be done for patients in arm 3 using baseline FMISO. The HSV will
be contoured and adjusted according to the second FMISO scan done between the 4th - the
5th week of radiation treatment. A planning CT will also be repeated at the time for
adjusting the HSV to account for temporal changes. The Biological Target Volume thus
generated after adequate margins will be prescribed 30 Gy in 10 fractions over and above
the standard fractination.
Arm group label:
Arm 3 - DE-HyART
Other name:
Dose escalated radiotherapy
Other name:
Hypoxic sub volume
Other name:
FMISO
Intervention type:
Radiation
Intervention name:
Standard Arm
Description:
The prescribed radiotherapy dose will be 70 Gy in 2 Gy per fraction daily. The elective
volume will be treated with 50 Gy in 2 Gy per fraction daily till the first 5 weeks. The
entire treatment will be delivered in a phased mannered using sequential planning.
Arm group label:
Arm 2 - Hypoxic Comparator Arm
Other name:
Standard Sequential fractionation without dose escalation
Intervention type:
Drug
Intervention name:
Cisplatin injection
Description:
Concurrent chemotherapy, weekly Inj Cisplatin 40mg/m2. This will be given if clinically
indicated
Arm group label:
Arm 1 - Non-hypoxic arm
Arm group label:
Arm 2 - Hypoxic Comparator Arm
Arm group label:
Arm 3 - DE-HyART
Intervention type:
Radiation
Intervention name:
Standard fractionation (Radiation Oncology preference)
Description:
Standard institutional practice is detailed before starting the patient. Doses 66-70 Gy
over 6-7 weeks
Arm group label:
Arm 1 - Non-hypoxic arm
Summary:
DE-HyART is a phase II clinical trial aimed at understanding the effects of escalating
radiation doses to hypoxic sub-volumes inherent to squamous cell head and neck cancer.
The study is aimed at assessing locoregional control, feasibility, and acceptable
toxicity with such a strategy.
Detailed description:
DE-HyART is a randomized, non-blinded study that assesses the effects of combining IMRT
(using SIB-Sequential planning) with dose-escalation to hypoxic sub-volume delineated
using [18-F] FMISO. The treatment protocol will also include concurrent chemotherapy with
cisplatin at standard uniform dosing.
Patients with HNSCC whose cancer is determined to originate from the oral cavity,
oropharynx, larynx, and hypopharynx will be selected. The included patients will be
subjected to [18F] FMISO scan, labeled as baseline FMISO. Depending upon the result of
the baseline FMISO, the patient will be either hypoxic or anoxic. Patients exhibiting no
hypoxia in their tumor will be labeled as Arm 1 and act as an external cohort. Patients
with hypoxia will be randomized (1:1) into two arms - Arms 2 and 3. Both arms will be
subjected to chemoradiation by IMRT and concurrent chemotherapy with cisplatin at
40mg/m2. In Arm 3, the trial arm will receive an additional 10 Gy @ 2 Gy per fraction in
phase II (total 80 Gy) to the HSV + 5mm isotropic margin.
One twenty-four patients will recruited in a 1:1 fashion between Arm 3 and Arm 2. The
primary endpoint will be locoregional control and its possible increase in control.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Age: 18 - 70 years
- Willingness to sign informed consent (written/video documentation)
- Performance status: ECOG 0 - 2
- Histology proved - squamous cell carcinoma
- Any grade, gender
- Tumour sites: Oral Cavity, Oropharynx, Hypopharynx and Larynx
- Sufficient bone marrow reserve within the last 14 days.
- Hb: > 10g/dl (corrected)
- TLC: > 4,000 per cumm
- Platelet: >1.5Lakh per cumm
- Liver functions and kidney functions within normal limits
- Nutritional and dental assessment before inclusion into the study
Exclusion Criteria:
- HPV (p16) positive tumours
- Prior surgery and/or radiation therapy given for any HNC
- T1/T2 Glottis
- Metastatic disease or disease not amenable for definitive locoregional treatment.
- Medical co-morbidity hampering the administration of radiation and/or chemotherapy
(cisplatin)
- Pregnancy or lactation
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Rajiv Gandhi Cancer Institute and Research Centre
Address:
City:
Delhi
Zip:
110085
Country:
India
Status:
Recruiting
Contact:
Last name:
Sarthak Tandon, DNB Radiation Oncology
Phone:
(+91)11-47022009
Email:
drsarthaktandon@yahoo.in
Investigator:
Last name:
Munish Gairola, MD, DNB Radiation Oncology
Email:
Principal Investigator
Investigator:
Last name:
Sarthak Tandon, DNB Radiation Oncology
Email:
Sub-Investigator
Start date:
April 8, 2024
Completion date:
April 2028
Lead sponsor:
Agency:
Rajiv Gandhi Cancer Institute & Research Center, India
Agency class:
Other
Collaborator:
Agency:
Varian, a Siemens Healthineers Company
Agency class:
Industry
Source:
Rajiv Gandhi Cancer Institute & Research Center, India
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06087614
