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Dose Escalation Versus Standard in Laryngopharyngeal Cancers

NCT02757222 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2023-12-28

No results posted yet for this study

Summary

The primary objective of the study is to establish the safety of using a moderate escalation of radiotherapy dose in advanced/poor prognosis OPC and LH cancers receiving curative radiotherapy.

The study will also explore the efficacy (improvement in complete response rates at 2 years) of dose escalation in intermediate and high risk OPC and LH cancers patients.

Conditions

  • Malignant Neoplasm of Oropharynx Stage III
  • Malignant Neoplasm of Larynx Stage III
  • Malignant Neoplasm of Hypopharynx Stage III
  • Malignant Neoplasm of Oropharynx Stage IVa
  • Malignant Neoplasm of Oropharynx Stage IVb
  • Malignant Neoplasm of Larynx Stage IV
  • Malignant Neoplasm of Hypopharynx Stage IVa
  • Malignant Neoplasm of Hypopharynx Stage IVb

Interventions

RADIATION

Escalated Dose

Boost Target Volume (BTV): The PET CT GTV (thresholding at 40% of SUV max) with a 3mm margin will form the BTV. CTV1: A 3mm area around the BTV avid primary or 2mm area around the node will form the CTV1. CTV 2: This (CTV 2) includes the area around the primary or nodal levels at risk of harbouring microscopic primary or microscopic nodal metastatic disease and not already included in CTV1. Planning Target Volume: PTV - A margin of 5mm will be added to each of the CTV to obtain the PTV. BTV receives 73.5Gy in 30 fractions. PTV 1 receives 63Gy in 30 fractions. PTV 2 receives 54 Gy in 30 fractions. All patients receive concurrent platinum chemotherapy.

RADIATION

Standard Dose

CTV 1 includes 6mm isotropic margin around the entire PET-CT avid (thresholding at 40% of SUV max) larynx/ hypopharynx /oropharynx and 5mm isotropic margin around nodes. CTV 2: This (CTV 2) includes the area around the primary or nodal levels at risk of harbouring microscopic primary or microscopic nodal involvement, or at risk nodal areas, and not already included in CTV1. Planning Target Volume: PTV - A margin of 5mm will be added to each of the CTV to obtain the PTV. PTV 1 receives 66Gy in 30 fractions. PTV 2 receives 54 Gy in 30 fractions. All patients receive concurrent platinum chemotherapy.

Sponsors & Collaborators

  • Tata Medical Center

    lead OTHER

Principal Investigators

  • Sanjoy Chatterjee, FRCP, FRCR · Tata Medical Center: Kolkata

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2022-12-31
Completion
2022-12-31

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02757222 on ClinicalTrials.gov