IMPT Dose Escalation for NSCLC (HyDose)

Browse trials for

• Carcinoma, Non-Small-Cell Lung 6,485
• Lung Neoplasms 7,243

Keywords

• Lung Neoplasms
• Proton Therapy
• Radiotherapy

Carcinoma, Non-Small-Cell Lung

6,485 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,630 are open to participants now.

This study's planned enrollment of 87 is above the median of 62 across 5,211 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.

Lead sponsor

University Medical Center Groningen is the lead sponsor of 609 studies on the registry; 174 are open to participants now.

Study arms

• Experimental
  Arm 1 Intervention group

  Dose-escalated IMPT

  Radiation: Dose-escalated intensity-modulated proton therapy (IMPT-74) · Drug: Cisplatin or carboplatin + pemetrexed for induction chemotherapy, cisplatin + docetaxel for concurrent chemotherapy · Drug: Immunotherapy: adjuvant durvalumab

Interventions

• RadiationDose-escalated intensity-modulated proton therapy (IMPT-74)

  Heterogeneous simultaneous integrated boost of 74.0 Gy (RBE) to primary tumor \>15mm away form mediastinal envelope, and 64.0 Gy (RBE) to primary tumor =\< 15mm away from mediastinal envelope. The rest of the clinical target volume, including affected lymph nodes, receives 60.0 Gy (RBE).

• DrugCisplatin or carboplatin + pemetrexed for induction chemotherapy, cisplatin + docetaxel for concurrent chemotherapy

  Induction course: -Cisplatin (75 mg/m2) or carboplatin (AUC 6) + pemetrexed (500mg/m2). Concurrent chemoradiotherapy: * Weekly cisplatin (20mg/m2) + docetaxel (20mg/m2) on Mondays. * Radiotherapy will be given for 5x5 days.

• DrugImmunotherapy: adjuvant durvalumab

  Adjuvant treatment will be given starting 1-6 weeks after chemoradiotherapy if no progression, good performance (PS 0-1), no other contra-indication for immunotherapy. Doses: * Start durvalumab 10 mg/kg 1x/14 days. * If possible after 2 courses switch to 1500 mg flat dose 1x/4 wk. * Continue for 12 months in total.

Primary outcomes

1. Severe (grade 3+) adverse effects up to six months after radiotherapy

   Time frame: Data for assesing safety will be recorded from day 1 to 365

Secondary outcomes

1. Local control of the lung tumour assessed by the treating physician and radiologist according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1)

   Local control was defined as the time from randomization until the date of objective disease progression in the lungs (RECIST 1.1). Local progression was defined using RECIST 1.1 as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Local control was calculated using the Kaplan-Meier technique.

   Time frame: Data for assessing local control will be recorded up to 2 years after chemoradiotherapy

2. Progression-free survival based on review by the treating physician and radiologist according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1)

   PFS was defined as the time from randomization until the date of objective disease progression (RECIST 1.1) or death (by any cause in the absence of progression). Progression was defined using RECIST 1.1 as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. PFS was calculated using the Kaplan-Meier technique.

   Time frame: Data for assessing progression-free survival will be recorded up to 2 years after chemoradiotherapy

3. Distant metastasis control based on review by the treating physician and radiologist according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1)

   Time to distant metastasis was defined as the time from the date of randomization until the first date of distant metastasis. Distant metastasis was defined as any new lesion that was outside of the radiation field according to RECIST 1.1 or proven by biopsy. Time to distant metastasis was calculated using the Kaplan-Meier technique.

   Time frame: Data for assessing distant metastasis will be recorded up to 2 years after chemoradiotherapy

4. Overall survival

   Time frame: Data for assessing overall survival will be recorded up to 2 years after chemoradiotherapy

5. Grade 2+ adverse effects (i.e., requiring medication), both acute and late

   Time frame: Data for assesing safety will be recorded from day 1 to 365

6. Qualifying for adjuvant immunotherapy after finishing chemoradiotherapy yes/no

   Time frame: Data on qualifying for adjuvant immunotherapy will be recorded up to 6 weeks after finishing chemoradiotherapy

7. European Organization for Research and Treatment of Cancer Quality of Life Questionnaires Core-30 item (EORTC QLQ-C30)

   The EORTC QLQ-C30 is a disease specific measurement instrument for use in patients with or cured from cancer. It measures a number of aspects of quality of life, namely: physical functioning; role functioning; emotional functioning; cognitive functioning; social functioning. It also evaluates symptoms, such as pain, nausea, sleep, dyspnea, cancer related fatigue, and constipation, diahorrea, and fincancial problems, as well as two questionas about overall quality of life. The questionnaire consists of a total of 30 items, divided over 9 subscales. The items are on Likert scales. The scores for each subscale can be calculated on a 0-100 scale, as well as the total score. A high score for a functional scale represents a high/healthy level of functioning. A high score for global health status / QoL represents a high QoL. By contrast, a high score for a symptom scale/item represents a high level of symptomatology/problems.

   Time frame: Data for assesing quality of life will be recorded up to day 730

8. European Organization for Research and Treatment of Cancer Quality of Life Questionnaires Lung Cancer 13-item (EORTC-QLQ-LC13)

   The EORTC QLQ-LC13 is a 13-item lung cancer-specific questionnaire module meant as a disease-specific extension to the EORTC QLC-C30. It contains both multi-item (dyspnea) and single-item (all others) measures of lung cancer-associated symptoms (i.e. coughing, haemoptysis, dyspea and pain) and side-effects from conventional chemo- and radiotherapy (i.e. hair loss, neuropathy, sore mouth and dysphagia). The items are scored on likert scales, and can be converted to a 0-100 scale for each symptom and side effect. A high score represents a high level of symptomatology or problems.

   Time frame: Data for assesing quality of life will be recorded up to day 730

9. 3 EuroQoL-5D three-level version (EQ-5D-3L)

   This questionnaire consists of two pages: the EQ-5D descriptive system and the EQ-5D visual analogue scale (EQ VAS): * The descriptive system comprises five dimensions, each describing a different aspect of health: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has three levels: no problems, some problems, extreme problems (labelled 1-3). The respondent indicates their health by checking the box against the most appropriate statement in each of the five dimensions. * The EQ VAS redords the respondent's self-rated health on a vertical VAS where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. This information can be used as a quantitative measure of health outcome as judged by the individual respondents.

   Time frame: Data for assesing quality of life will be recorded up to day 730

10. Lymphocyte counts after finishing chemoradiotherapy

    Time frame: Data for assessing lymphocyte counts will be assessed between 4 and 6 weeks after chemoradiotherapy