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Randomized Study of Carbon Ion Boost in Hypoxic Lesions for Locally Advanced Non-small Cell Lung Cancer

ConditionNon-small Cell Lung Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorJian Chen

About this trial

The goal of this randomized clinical trial is to learn about if carbon ion radiotherapy dose boost in hypoxia lesions detected by 18F-Misonidazole PET/CT could improve clinical outcomes in locally advanced non-small cell lung cancer patients compared with standard treatment protocol in our center. The patients will be randomly divided into two arms: standard treatment arm and hypoxic lesions dose boost arm. The standard treatment arm will receive carbon ion beam radiotherapy of 77Gy (RBE equivalent) per 22 fractions for gross tumor volume. The hypoxic lesions dose boost arm will receive 77Gy (RBE equivalent) per 22 fractions for gross tumor volume and a simultaneously dose boost of 83.6Gy (RBE equivalent) per 22 fractions for hypoxic lesions detected by 18F-Misonidazole PET/CT.

Researchers will compare the local progression-free survival of two groups (primary endpoint), progression-free survival (secondary endpoint), overall survival (secondary endpoint), response rate (secondary endpoint), factional hypoxia volume (FHV) reduction rate (secondary endpoint) and toxicities (secondary endpoint).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Between the ages of 18 and 80.

ECOG general status score of 0-2 .

Primary non-small cell lung cancer (NSCLC) confirmed by histology or cytological pathology, stage IIIa-IIIc (AJCC/UICC 8th edition). Largest diameter of primary tumor ≥ 4cm before carbon ion radiotherapy.

Medically inoperable, or patient refuses surgery.

Disqualifiers

Patients with squamous cell carcinoma treated with bevacizumab before radiotherapy.

Patient fails to comply with the treatment protocol.

Complicated with other malignant tumors that have not been controlled.

Patient whose particle radiotherapy plan cannot meet the minimum target dose coverage and dose volume limitation requirements, or cannot meet the dose constrains of normal tissue or organs.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Standard carbon ion beam radiotherapy

    Radiation

    The standard treatment arm will receive carbon ion beam radiotherapy of 77Gy (RBE equivalent) per 22 fractions for gross tumor volume.

  • Carbon ion beam radiotherapy simultaneously dose boost

    Radiation

    The hypoxic lesions dose boost arm will receive 77Gy (RBE equivalent) per 22 fractions for gross tumor volume and a simultaneously dose boost of 83.6Gy (RBE equivalent) per 22 fractions for hypoxic lesions detected by 18F-Misonidazole PET/CT.

Treatment groups

77 Participants
are divided into 2 treatment groups
Group A: Standard treatment armActive comparator 1 intervention
Group B: Boost armExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Local progression-free survival

Local progression-free survival was defined from the start of carbon ion radiotherapy till the date of local progression or the last follow-up

Time frame
From date of radiotherapy started until the date of first documented local disease progression, assessed up to 100 months

Secondary outcomes

1

Disease progression-free survival rate

Disease progression-free survival rate was defined from the start of carbon ion radiotherapy till the date of disease progression at any site or death, or the last follow up

Time frame
From date of radiotherapy started until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
2

Overall survival rate

Overall survival rate was defined from the start of carbon ion radiotherapy till the date of death or the last follow-up

Time frame
From date of radiotherapy started until the date of death from any cause, assessed up to 100 months
3

Overall response rate

Proportion of complete response and partial response in all patients

Time frame
From date of radiotherapy started until 6 months after first radiotherapy
4

Change of fractional hypoxia volume

The hypoxia volume of the hypoxia-positive region of interested was defined as the sum of pixels with a tumor muscle rate ≥1.4. The FHV, defined as the HV-to-gross tumour volume ratio. The FHV before and after carbon ion radiotherapy within 1 month will be recorded.

Time frame
From date of radiotherapy started until 1 month after first radiotherapy

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jian Chen

Lead sponsor

Shanghai Proton and Heavy Ion Center

Sponsor institution

Source ClinicalTrials.gov
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