Clinical trial

A Phase II Randomised Controlled Study Assessing the Role of Dose Escalation Using [18F] FMISO PET CT in Head and Neck Cancer: The DE-HyART (Dose Escalation Using Hypoxia-adjusted Radiotherapy) Protocol

Name

Res/SCM/58/2023/33

Description

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.

Trial arms

Trial start

2024-04-08

Estimated PCD

2028-04-01

Trial end

2028-04-01

Status

Recruiting

Phase

Early phase I

Treatment

DE-HyART

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.

Arms:

Arm 3 - DE-HyART

Other names:

Dose escalated radiotherapy, Hypoxic sub volume, FMISO

Standard Arm

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.

Arms:

Arm 2 - Hypoxic Comparator Arm

Other names:

Standard Sequential fractionation without dose escalation

Cisplatin injection

Concurrent chemotherapy, weekly Inj Cisplatin 40mg/m2. This will be given if clinically indicated

Arms:

Arm 1 - Non-hypoxic arm, Arm 2 - Hypoxic Comparator Arm, Arm 3 - DE-HyART

Standard fractionation (Radiation Oncology preference)

Standard institutional practice is detailed before starting the patient. Doses 66-70 Gy over 6-7 weeks

Arms:

Arm 1 - Non-hypoxic arm

Size

124

Primary endpoint

Locoregional Control (LRC)

Disease recurrence locally or analysis cut-off point. The analysis cut off pint is 24 months

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 124, 'type': 'ESTIMATED'}}

Updated at

2024-04-10

1 organization

1 drug

1 indication

Organization

Rajiv Gandhi Cancer Institute & Research Center

Drug

Cisplatin

Indication

Head and Neck Squamous Cell Carcinoma