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Omitting CTV for Primary Tumor in LS-SCLC

ConditionsSCLC, Limited StageRadiation ExposureRadiotherapy Side EffectProgression
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSun Yat-sen University

About this trial

This randomized controlled non-inferior trial prospectively enrolled patients with limited-stage small cell lung cancer (LS-SCLC). Patients in the experimental group would receive radiotherapy with omission of the clinical target volume (CTV) for the primary tumor, while those in the control group would receive radiotherapy including CTV. The efficacy and toxicity of the two groups are compared to provide evidence for the radiotherapy of LS-SCLC. The target volume of LS-SCLC may be reduced by omitting CTV without increasing local recurrence but potentially reducing the dose to organs at risk and the side effects.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Small cell lung cancer confirmed by histology or cytology; TNM stage IA-IIIC (AJCC 8th edition, 2017; limited-stage) without intrapulmonary metastasis;

Aged 18-75 years, KPS score ≥ 80, ≤ 10% weight loss within the past 6 months;

Have measurable lesions per RECIST 1.1 criteria;

Have no disease progression after 2-4 cycles of etoposide/carboplatin or etoposide/cisplatin;

Disqualifiers

Other malignant tumors (prior or concurrent), except those that have been curatively treated with disease-free survival ≥ 5 years, such as non-melanoma skin cancer, cervical carcinoma in situ, or early-stage papillary thyroid cancer;

Uncontrolled heart disease or myocardial infarction within the past 6 months;

Patients with a history of mental illness;

Pregnant and lactating patients;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Radiation Therapy

    Radiation

    Twice-daily (45 Gy/30 fractions) or once-daily (45 Gy/15 fractions) thoracic radiotherapy after 2-4 cycles of chemotherapy

  • Etoposide + carboplatin; Etoposide + cisplatin

    Drug

    Carboplatin IV (AUC=5) on day 1 combined with etoposide IV (100mg/m2) on days 1-3, or cisplatin IV (25mg/m2) on days 1-3 combined with etoposide IV (100mg/m2) on days 1-3. Treatment is repeated every 21 days for 4-6 cycles.

  • Creating CTV for primary tumor

    Radiation

    A margin of 0.8 cm beyond the gross target volume of primary tumor.

  • prophylactic cranial irradiation (PCI)

    Radiation

    Beginning 4-6 weeks after chemoradiotherapy completion, patients in both arms who achieve a complete or partial response without brain metastasis receive PCI at 25 Gy/10 fractions or 26 Gy/13 fractions, delivered once daily (5 days per week).

Treatment groups

852 Participants
are divided into 2 treatment groups
Group A: Control groupActive comparator 4 interventions
Group B: Experimental groupExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Local progression free survival

Time frame
From the date chemotherapy commenced to the first clinical or radiological evidence of progressive disease at the primary site or death, whichever occurs first, to be assessed up to 3 years
2

Severe toxicity free survival

Time frame
From the date chemotherapy commenced to the first record of serious adverse events related to radiotherapy, to be assessed up to 3 years

Secondary outcomes

1

Overall survival

Time frame
From the date chemotherapy commenced to the date of death from any cause or the end of follow-up at 3 years
2

Progression free survival

Time frame
From the date chemotherapy commenced to disease progression or death, whichever occurs first, to be assessed up to 3 years
3

Number of participants with recurrence or metastasis as evaluated by RECIST 1.1

Time frame
From the date chemotherapy commenced to the end of follow-up at 3 years
4

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Time frame
From the date chemotherapy commenced to the end of follow-up at 3 years

Other outcomes

Sponsors and contacts

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

Sun Yat-sen University

Lead sponsor

Source ClinicalTrials.gov
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